Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention

Abstract

Objectives

This study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico.

Design

We conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention’s effect on patients’ supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention’s benefits and barriers and understand its feasibility.

Participants

50 women aged 20–75 diagnosed with stage I–III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers.

Setting

Oncology services in three public hospitals of the Mexican Social Security Institute.

Intervention

The ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks.

Results

50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms.

Conclusions

This pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation.

Trial registration number

ClinicalTrials.gov ID: NCT05925257.

Correspondence to Dr Svetlana V Doubova; [email protected]

Strengths and limitations of this study

• The study combined quantitative and qualitative methods to provide evidence on the effects of the intervention as well as acceptability, feasibility, usability, perceived benefits and barriers from both patient and healthcare provider perspectives.

• Retention was high in the study, attributed to the user-friendly electronic patient-reported outcome application and the patient-centred approach of the nurses in their follow-up with the women.

• Given the non-randomised pre-test/post-test design, the observed effects on quality of life and supportive care needs could be attributable in part to factors besides the intervention, such as expected improvements over the course of cancer treatment.

• Generalisability of this initial pilot study is limited to major oncology hospitals and to literate patients without visual impairment, cognitive disability or severe depression.

Introduction

The incidence of breast cancer has increased in Mexico in the past 60 years, with the health system struggling to provide timely diagnosis and treatment to avert morbidity and mortality.^{1 2} Breast cancer treatment typically involves a combination of local treatments, such as surgery and radiation therapy, and systemic treatments, such as chemotherapy, hormonal therapy or targeted molecular therapy. Treatment side effects can negatively impact a patient’s physical and emotional health and quality of life, potentially interrupting cancer treatment and decreasing the patient’s chances of survival.³ Patient-centred cancer care is intended to address needs arising from the disease as well as those related to treatment and its side effects.⁴ Patient-reported outcome measures (PROs) have been developed to guide patient-centred care by aligning health services with patients’ values. Electronic PRO (ePRO) interventions have been proposed to facilitate patient-centred cancer care.^{5 6} These interventions have been proven effective in enhancing communication between patients and healthcare professionals, monitoring treatment side effects, promoting patient participation in their care and ultimately improving health outcomes.^{5 6}

The Mexican Institute of Social Security (IMSS) is Mexico’s largest public healthcare system: it provides healthcare to over 70 million people (57% of the national population), mainly formal labour market workers and their families.⁷ In 2022, IMSS treated 71 000 women for breast cancer.⁸ To provide this treatment, IMSS has specialised oncology breast services in 22 secondary hospitals, 6 general hospitals and 3 tertiary hospitals.⁹ Currently, these services do not provide digital monitoring of patients’ supportive care needs, although patients undergoing breast cancer treatment have reported information gaps on their condition, treatment-related side effects and non-pharmacological treatment options.^{10 11} Nearly all women treated for breast cancer at IMSS reported at least one unmet supportive care need, including health systems and information needs as well as psychological, physical, sexuality and patient care needs.⁵

To address the supportive care needs of women with breast cancer at IMSS, we designed an intervention combining a responsive web application registry to capture symptoms and supportive care needs with proactive follow-up by nurses guided by predefined clinical algorithms.¹² Following validation of the intervention content, we conducted a non-randomised pilot study to assess intervention acceptability, feasibility, usability and preliminary effects and to adapt the intervention and study procedures in preparation for an effective randomised controlled trial (RCT).

Methods

Design and setting

We conducted a multimethod non-randomised pilot study from August 2023 to February 2024 within the oncology services of three IMSS hospitals, two in Mexico City and one in Puebla city. We used a pre-test/post-test design for quantitative assessment of the intervention’s effect on patients’ supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with patients and healthcare workers to explore the intervention’s benefits and barriers and understand its acceptability and feasibility through thematic analysis.

Patient and public involvement

Patients participated in the previously reported development of the intervention¹²; those participating in IDIs helped to inform the planned RCT.

Quantitative stage

Study population and eligibility criteria

Intervention eligibility was defined as women between 20 and 75 years diagnosed with stage I–III breast cancer who: have started neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy within the past 2 weeks; have access to the internet via mobile phone, computer or tablet; and provided written informed consent. The study excluded women with stage IV breast cancer, illiterate women and those with blindness or low vision not corrected with glasses, cognitive disability (eg, Alzheimer’s disease, other dementias or other mental illness with intellectual disability) or severe depression (≥12 points on the Hospital Anxiety and Depression Scale).¹³

During the study, oncologists notified the research team daily of patients who met the selection criteria. Then, two nurses hired and trained for the study contacted these patients, verified the selection criteria and invited them to participate. An in-person appointment was scheduled to provide further information about the study and obtain signed informed consent. Women who agreed to participate were assigned a username and password to access the ePRO application and were trained on its use.

Intervention

The pilot implementation of the ePRO intervention included 6 weeks of using a responsive web application with weekly reporting of symptoms and supportive care needs and follow-up by nurses guided by predefined clinical algorithms, as described in the study protocol.¹²

In the ePRO application, the weekly symptoms report asked about the presence and severity of 20 symptoms commonly experienced by women with breast cancer during neoadjuvant and adjuvant chemo and radiotherapy. These symptoms include (1) pain, (2) fatigue, (3) nausea and/or vomiting, (4) constipation, (5) diarrhoea, (6) anorexia, (7) dyspnoea, (8) insomnia, (9) oral mucositis, (10) pruritus, (11) acute radiodermatitis, (12) palmar-plantar erythrodysesthesia, (13) papulopustular rash, (14) lymphoedema, (15) proctitis, (16) peripheral neuropathy, (17) infusion phlebitis, (18) anxiety and depression and (19) changes in sexuality and other symptoms.¹² In addition, the ePRO application also inquired about characteristics that help define the severity of these symptoms as mild, moderate or severe. For instance, patients reporting any pain symptoms were asked to rate their level of pain from 1 to 6 (with accompanying emoticons) and to identify what activities of daily living they had difficulty completing due to pain. Classification of symptoms was based on the PRO Common Terminology Criteria for Adverse Events: grade 1=mild, grade 2=moderate and grades 3 and 4=severe.¹⁴ Complete details on intervention content are provided in the published study protocol.¹²

Participants were asked to report symptoms weekly on enrolment into the study; those who did not record symptoms for two consecutive weeks were contacted by phone by nurses.

Women who registered mild symptoms received automated messages via email or SMS with non-pharmacological recommendations. For those with moderate and severe symptoms, the nurses received immediate automatic alerts by email and followed-up with patients by telephone within 5–20 min to provide non-pharmacological guidance. The nurses had the support of an oncologist to resolve complex cases and were in constant contact with the research team to address any questions or concerns. The nurses’ working hours were from 8:00 to 20:00, Monday through Friday. All participants were informed that if they experienced severe symptoms outside of these hours, or did not receive a response within 20 min after recording their symptoms, they should go to the emergency room if the severe symptoms persisted or worsened. Nurses recorded their follow-up activities in the nursing interface in the ePRO application.

To facilitate the use of the ePRO application, women were given a prepaid internet data recharge for 1 month. Throughout the pilot study, participants received usual oncological care according to IMSS protocols.

Data collection

Participants consenting to the study were provided an orientation to the ePRO application and then responded to a baseline assessment within the application that included clinical and demographic details as well as supportive care needs and quality of life measures. After 4 weeks of using the ePRO application, participants completed the follow-up assessment with the same measures and a questionnaire on application usability; they were asked to use the application for an additional 2 weeks without support for internet payment, in order to assess its usability with and without data recharge. We monitored application use throughout the 6 weeks based on visits by IP address and symptom alerts registered.

Outcome variables

The primary pilot study outcome was the usability of the web application at the 4-week time point, measuring using the mHealth App Usability Questionnaire (MAUQ) for interactive mHealth Apps (patient version).¹⁵ This 21-item questionnaire measures ease of use and satisfaction, system information arrangement and application usefulness, using 7 responses from 1 to 7 and the global score is obtained by summarising responses to all items and dividing it by 21, the score close to 7 means the higher usability of the application.

We also tracked the frequency of responsive ePRO application use (site visits by IP address) and the completion of weekly reports of symptoms and supportive care needs. We calculated recruitment rate (number of recruited women/number of eligible women×100) and retention rate (number of women providing the outcomes of interest/number of recruited women×100). We defined adherence to the ePRO application as per cent of weekly symptom registries completed out of a maximum of six.

Secondary outcomes included the health systems and information supportive care needs domain, measured by the Supportive Care Needs Survey Short Form 34, previously validated in Mexico.¹⁶ This scale comprises 34 items and assesses 5 domains: (1) psychological needs, (2) health systems and information needs, (3) physical and daily living activities needs, (4) care needs and (5) needs related to sexuality. It uses a 5-point Likert scale to measure if a patient needs support and the extent of such need. Each domain score is standardised and ranges from 0 to 100, with a high score indicating a high need.

We also measured the global quality of life using the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire (QLQ)-C30 and breast symptoms by applying the EORTC QLQ-BR23. Both questionnaires were validated in Mexico.^17–19 The EORTC QLQ-C30 questionnaire comprises 30 items and includes 5 functional scales (physical functioning, role emotional, cognitive and social), 3 symptom scales (fatigue, pain, nausea/vomiting), a global quality of life scale and 6 single items (shortness of breath, loss of appetite, insomnia, constipation, diarrhoea and economic difficulties).

The breast cancer questionnaire EORTC QLQ-BR23 comprises 23 items and has been validated among patients with Mexican cancer. It includes five symptom scales (body image, sexual functioning, systemic therapy side effects, breast and arm symptoms) and six single items (sexual enjoyment, future perspective and upset by hair loss).

For both questionnaires, we used linear transformation to standardise raw summary scores. The standardised scores range from 0 to 100 for each scale, with the higher scores representing a higher quality of life or higher intensity of symptoms.^{20 21}

The outcome variables were obtained through the baseline and 1-month evaluations in the ePRO application.

Study covariates

The covariates comprised participant demographic and clinical characteristics including age, formal educational attainment (primary school or less and secondary school or higher), marital status, number of people who live in the patient’s home, number of people who provide caregiving to the patient, time since cancer diagnosis (in weeks), cancer stage (I, II or III) and type of treatment (chemo, or radiotherapy), local/regional recurrence, chronic diseases prior to cancer diagnosis (eg, diabetes, hypertension).

Sample size

We determined the required sample size in consideration of three planned analyses: usability of the ePRO application, preliminary effect in reducing supportive care needs and trial feasibility in preparation for larger studies. Conservatively assuming 10% attrition, the 45 participants provide sufficient sample to yield a 95% CI of width 14% (margin of ±7) on the MAUQ score and 90% probability that the CI width will be no larger than 14 in a future study. Based on prior studies among patients with breast cancer providing an average score of 45 (SD=29) on supportive care needs in the health system information domain,^{4 5} we will have 80% power to detect an improvement of at least 11 points (45 vs 34) between pre-test and post-test on a one-sided paired comparison with alpha set to 0.05 and within-person correlation of 0.5. Finally, the pilot study has a sufficient sample to detect study design problems with an expected prevalence of 6% or greater with 95% confidence.²²

Statistical analysis

We conducted a descriptive analysis of participants’ baseline socio-demographic and clinical characteristics, the frequency of responsive ePRO application use, the completion of a weekly report of symptoms and supportive care needs and ePRO application usability based on MAUQ score at the 4-week follow-up.

We used the McNemar test to compare baseline and 4-week proportions (supportive care needs by domain and proportion of women with anxiety and depression). Due to the non-normal distribution of the numerical study variables verified through the Shapiro-Wilk test, we compared the medians of the variable’s baseline scores (pre-test) and 4-week scores (post-test) using the Wilcoxon signed-rank test (paired data). A p value of ≤0.05 was considered statistically significant. The analysis was performed using Stata V.17.0 statistical software.

Qualitative stage

Study population

During the qualitative stage of the study, we interviewed 10 healthcare providers, including 2 chiefs of oncology services, 4 medical oncologists, 2 radiation oncologists and 2 nurses, including all healthcare providers providing breast cancer care in the study hospitals. Additionally, we interviewed 18 women who participated in the pilot study, 9 of whom had high adherence to the intervention (≥70%) and 9 with low adherence (<70%). We used purposeful sampling to identify women with diverse clinical and socio-demographic characteristics with regard to their age, level of schooling and type of cancer treatment. The number of qualitative stage participants was determined based on the recommendation of a systematic review of the sample sizes for saturation in qualitative research.²³

Healthcare providers were an average of 36.5 years old (SD=5.9), with an average of 7.9 years (SD=4.4) of experience treating patients with breast cancer. The average age of the women was 49.9 years, with an SD of 10.4. 61% of participants received chemotherapy.

Data collection

We developed a semi-structured interview guide (online supplemental material 1) to capture perceived benefits and barriers to better understand the acceptability, feasibility and usability of the ePRO intervention; the guide was adapted for use with patients and with healthcare providers. We drew from the Consolidated Framework for Implementation Research in identifying implementation domains for consideration.²⁴ The interviews were conducted by a psychologist with a master’s degree and research experience. All interviews were conducted in Spanish, audio recorded and transcribed for analysis.

Data analysis

The data were analysed using inductive thematic analysis.²⁵ Three researchers (SVD, SECS and IPMV) analysed the interviews separately. Individual decisions on emerging themes and the classification of responses were cross-checked to ensure consistency and reliability of the coding. In the cases of discrepancy, the classification of responses into themes and subthemes was corroborated through discussion and collective agreement. During the analysis, we looked for common and specific themes for each group of participants (patients and providers). The illustrative interview excerpts were labelled according to the type of participant—patient with breast cancer (BCP), healthcare provider (HP)—and with study identifier, age, level of schooling and type of undergoing treatment—chemotherapy (CT) or radiotherapy (RT) reported for patients.

Ethics

The National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants signed an informed consent form prior to joining the study (online supplemental material 2). The RCT was registered at ClinicalTrials.gov.

Results

Quantitative stage

Out of 107 women identified as potential participants, 17 were unreachable by phone, 3 denied receiving any study-related information and 1 passed away before being invited (figure 1). 20 of the 86 remaining women (23.3%) did not meet inclusion criteria. Out of 66 women who met the inclusion criteria, 16 declined to participate (24.2%) mainly due to lack of time or interest, while 50 women agreed to participate, resulting in a recruitment rate of 75.8%.

Figure 1. Pilot study flowchart of recruitment.

We initially attempted to enrol patients with breast cancer from a major IMSS oncology hospital in Mexico City, as per the study protocol. However, the number of eligible participants per week was extremely low, ranging from one to three women. Hence, after 2 months of recruitment, we invited two additional hospitals with breast cancer oncology services to join the study.

Table 1 describes the key characteristics of the pilot study participants. The mean age was 53.4 years with 60% completing secondary schooling. More than half were married and dedicated to household activities. Participants reported a median of 2 individuals helping to care for them, including their children (reported by 74% of participants) and husbands or common-law partners (54%). 44% had clinical stage III, 40% had clinical stage II and the mean time since diagnosis was 39.5 weeks. Half received CT, and another half received RT. Local recurrence in the breast was observed in only 6% of patients. The main comorbidities were diabetes mellitus (16%) and hypertension (20%).

Table 1

Socio-demographic and clinical characteristics of the study participants

Characteristics	n=50 n (%)
Age in years (mean±SD)	53.3±11.4
Schooling
None	5 (10.0)
Primary school	4 (8.0)
Secondary school	12 (24.0)
High school	18 (36.0)
University or higher	11 (22.0)
Occupation
Housekeeping	26 (52.0)
Administrative employee	9 (18.0)
Professional	6 (12.0)
Other	6 (12.0)
Civil status
Married	26 (52.0)
Free union	7 (14.0)
Single	6 (12.0)
Divorced/separated	5 (10.0)
Widow	6 (12.0)
Caregivers
Number (median and IQR)	2 (1–3)
Type*
Children	37 (74.0)
Husband or common-law partner	27 (54.0)
Father and/or mother	5 (10.0)
Other	5 (10.0)
Clinical stage
I	8 (16.0)
II	20 (40.0)
III	22 (44.0)
Weeks since diagnosis (median and IQR)	39.5 (12.0–58.0)
Type of treatment
Chemotherapy	25 (50.0)
Radiotherapy	25 (50.0)
Local recurrence	3 (6.0)
Comorbidities
Diabetes	8 (16.0)
Hypertension	10 (20.0)
Other	3 (6.0)

*The sum of the categories of the type of caregiver exceeds 100% due to participants reporting multiple caregivers.

On average, there were 203 website visits per IP address per month. Overall adherence to weekly symptom reporting was 76.3%, decreasing from 100% in the first week to 66% in the sixth week. Half of the participants had an adherence rate of 70% or higher.

Table 2 displays the frequency of alerts recorded by participants in the ePRO application. Out of 364 alerts, pain (17%), fatigue (15.4%), nausea (11%) and peripheral neuropathy (5.8%) were the most common symptoms reported. Among the registered symptoms, 33% were mild, 44.5% as moderate and 6.6% as severe. Additionally, 152 recordings specified ‘Doubts not-related to specific symptoms’. The median time nurses took to respond to moderate or severe alerts during business hours was 13 min, with an IQR of 8–20.5 min.

Table 2

Frequency of the responsive electronic patient-reported outcome application use by the level of severity

Reason for alert	Mild n (%)	Moderate n (%)	Severe n (%)	Doubts not-related to specific symptoms n (%)	n=364 n (%)
Pain	27 (43.6)	33 (53.2)	2 (3.2)	-	62 (17.0)
Fatigue	12 (21.4)	41 (73.2)	3 (5.4)	-	56 (15.4)
Nausea y/o vomit	21 (52.5)	16 (40.0)	3 (7.5)	-	40 (11.0)
Peripheral neuropathy	7 (33.3)	11 (52.4)	3 (14.3)	-	21 (5.8)
Diarrhoea	12 (80.0)	2 (13.3)	1 (6.7)	-	15 (4.1)
Insomnia	3 (23.1)	7 (53.8)	3 (23.1)	-	13 (3.6)
Acute radiodermatitis	5 (38.5)	8 (61.5)	0 (0.0)	-	13 (3.6)
Oral mucositis	7 (58.3)	5 (41.7)	0 (0.0)	-	12 (3.3)
Loss of appetite	3 (30.0)	7 (70.0)	0 (0.0)	-	10 (2.8)
Constipation	4 (40.0)	6 (60.0)	0 (0.0)	-	10 (2.8)
Pruritus	1 (11.1)	8 (88.9)	0 (0.0)	-	9 (2.5)
Infusion phlebitis	3 (42.9)	4 (57.1)	0 (0.0)	-	7 (1.9)
Anxiety symptoms	6 (85.7)	0 (0.0)	1 (14.3)	-	7 (1.9)
Proctitis	1 (16.7)	3 (50.0)	2 (33.3)	-	6 (1.7)
Dyspnoea	1 (20.0)	2 (40.0)	2 (40.0)	-	5 (1.4)
Lymphoedema	1 (25.0)	3 (75.0)	0 (0.0)	-	4 (1.1)
Depression symptoms	1 (25.0)	2 (50.0)	1 (25.0)	-	4 (1.1)
Aspects of sexuality	4 (100.0)	-	-	-	4 (1.1)
Palmar-plantar erythrodysesthesia	2 (66.7)	1 (33.3)	0 (0.0)	-	3 (0.8)
Papulopustular rash	0 (0.0)	1 (100.0)	0 (0.0)	-	1 (0.3)
Other	3 (4.8)	2 (3.2)	3 (4.8)	54 (87.0)	62 (17.0)
Total	120 (33.0)	162 (44.5)	24 (6.6)	58 (15.9)	364 (100.0)

Nearly all (96%) women accepted a 1-month internet data recharge for their cell phones. Use of the application was comparable during the month when they had Internet data recharge with two additional weeks when they did not, with an average of 86 weekly symptom reports in each period.

All participants completed the 4-week assessment. Participants rated the ePRO application usability highly, with an overall MAUQ score of 6.33 points out of 7 (95% CI of 5.98 to 6.59) and similar points in domains related to the application ease of use and satisfaction (6.38 points), system information arrangement (6.17 points) and its usefulness (6.21 points) (information not presented in the tables).

Table 3 shows the comparison between the baseline measurement and 1 month of the outcome variables of the pilot study. The median number of supportive care needs decreased significantly from baseline to 4-week assessment: 11 versus 3, difference −8. Likewise, there was a statistically significant reduction in the median scores of all domains of supportive care needs, mainly in needs related to health and information services (28.4 vs 13.6 points, difference −14.8) and in psychological needs (22.5 vs 10 points, difference −12.5). The EORTC QLQ-C30 global health score increased from 70.8 to 83.3 points (difference of +12.5), with similar increases in all functional scales, including role, social and emotional functioning. The EORTC QLQ-BR23 also showed an increase in the score for future perspective (from 33.3 to 66.7 points, difference of +33.4) and body image (from 75.0 to 91.7 points, difference of +16.7). Also, there was a statistically significant reduction in symptoms on the EORTC QLQ-C30, including constipation (from 33.3 to 0.0 points, difference of −33.37), side effects of systemic therapy (from 38.1 to 19.0 points, difference of −19.1) and nausea and vomiting (from 16.7 to 0.0 points, difference of −16.7), insomnia (from 33.3 to 16.7 points, difference of −16.6) and financial difficulties (from 33.3 to 16.7 points, difference of −16.6).

Table 3

Baseline and 4-week-comparison of the outcome variables

Variables (n=50)	Baseline	4-week	P value
	Median (percentile 25, 75)	Median (percentile 25, 75)
Supportive care needs (SCNS-SFM 34)
Number of supportive care needs	11 (3, 19)	3 (0, 6)	<0.001
Domain scores
Physical and daily living activities needs	25.0 (15.0, 45.0)	20.0 (5.0, 30.0)	<0.01
Psychological needs	22.5 (10.0, 47.5)	10.0 (5.0, 35.0)	<0.001
Health systems and information needs	28.4 (9.1, 43.2)	13.6 (2.3, 25.0)	<0.01
Care needs	15.0 (10.0, 45.0)	10.0 (0.0, 20.0)	<0.01
Needs related to sexuality	0.0 (0.0, 16.7)	0.0 (0.0, 8.3)	0.06
Presence of supportive care needs	n (%)	n (%)
Physical and daily living activities needs	28 (56.0)	11 (22.0)	<0.001
Psychological needs	24 (48.0)	14 (28.0)	<0.01
Health systems and information needs	27 (54.0)	8 (16.0)	<0.001
Care needs	22 (44.0)	8 (16.0)	<0.001
Needs related to sexuality	12 (24.0)	1 (2.0)	<0.01
Quality of life (EORTC QLQ-C30)
Global quality of life	70.8 (58.3, 83.3)	83.3 (66.7, 91.7)	<0.001
Physical functioning	86.7 (73.3, 93.3)	93.3 (86.7, 100.0)	<0.001
Role functioning	66.7 (66.7, 83.3)	100.0 (83.3, 100.0)	<0.001
Emotional functioning	70.8 (50.0, 83.3)	83.3 (75.0, 91.7)	<0.001
Cognitive functioning	83.3 (66.7, 100.0)	91.7 (83.3, 100.0)	0.02
Social functioning	66.7 (50.0, 100.0)	83.3 (83.3, 100.0)	<0.001
Quality of life (EORTC QLQ-BR23)
Body image	75.0 (50.0, 91.7)	91.7 (66.7, 100.0)	<0.001
Future perspective	33.3 (0.0, 66.7)	66.7 (66.7, 100.0)	<0.001
Sexual functioning	0.0 (0.0, 33.3)	0.0 (0.0, 16.7)	0.04
Symptoms and others (EORTC QLQ-C30)
Pain	25.0 (0.0, 50.0)	16.7 (0.0, 33.3)	<0.001
Fatigue	33.3 (22.2, 44.4)	22.2 (0.0, 33.3)	<0.001
Nausea and/or vomiting	16.7 (16.7, 33.3)	0.0 (0.0, 16.7)	<0.001
Dyspnoea	0.0 (0.0, 33.3)	0.0 (0.0, 0.0)	<0.001
Insomnia	33.3 (0.0, 33.3)	16.7 (0.0, 33.3)	<0.001
Loss of appetite	0.0 (0.0, 33.3)	0.0 (0.0, 33.3)	0.06
Constipation	33.3 (0.0, 33.3)	0.0 (0.0, 33.3)	<0.01
Diarrhoea	0.0 (0.0, 33.3)	0.0 (0.0, 0.0)	0.06
Financial difficulties	33.3 (0.0, 33.3)	16.7 (0.0, 33.3)	<0.01
Symptoms (EORTC QLQ-BR23)
Systemic therapy side effects	38.1 (23.8, 47.6)	19.0 (9.5, 28.6)	<0.001
Breast symptoms	25.0 (16.7, 41.7)	16.7 (8.3, 25.0)	<0.001
Arm symptoms	22.2 (11.1, 33.3)	11.1 (0.0, 22.2)	<0.001

EORTC, European Organisation for Research and Treatment of Cancer; QLQ, Quality of Life Questionnaire; SCNS-SFM 34, Supportive Care Needs Survey Short Form 34.

Qualitative stage

Analysis of patient IDIs identified four themes related to perceived ePRO intervention benefits and five related to barriers. For health personnel, we identified two themes related to benefits, four to barriers and five to the feasibility of implementing the ePRO application in clinical practice (figure 2).

Figure 2. Thematic map. ePRO, electronic patient-reported outcome; IMSS, Mexican Institute of Social Security.

Research area: I. perceived benefits of the ePRO intervention

Theme A: the ePRO application is user-friendly

Most women and health professionals expressed that the ePRO application is user-friendly because it is (A1) easily accessible, (A2) practical, simple and clear for symptom recording and (A3) visually appealing and illustrative, thanks to the use of images. They also noted that the colours used are not overwhelming or tiring to look at.

(A1, A2)

Access was really very easy. I have it on my phone, so I could use it anywhere that was available… So I think it is very practical to transport.…I am a little familiar with some applications, so for me, the application is simple and friendly. (BCP17, 52 years old, bachelor’s degree, RT)

(A2)

It is practical because it is only about answering whether or not I had [any symptom], selecting the image… In addition, I find the language to be very clear, very simple. (HP10, 34 years old, man, medical oncologist)

(A3)

The [ePRO] platform is very good, it is clear, very illustrative, …the colors are good, you don’t get tired of looking at it. (BCP3, 50 years old, postgraduate, RT)

…I like that there are images, not just text. It makes it visually pleasing and faster to understand. (BCP6, 35 years old, bachelor’s degree, CT)

Theme B: user-centred skills of nurses

Women expressed appreciation for the user-centred skills of nurses, including (B1) the promptness of nurses’ response to symptom alerts; (B2) the clarity of the recommendations, which were easy to understand and follow; (B3) communication through different means considering women’s preferences, including phone calls, WhatsApp messages, SMS and email and (B4) polite and humane treatment.

(B1)

…the response was almost immediate, just as I sent [the symptom record], about five, ten minutes later the nurses called me by phone, and they gave me the recommendations that I could follow to feel better. (BCP48, 39 years old, bachelor’s degree, CT)

Among the benefits I had is receiving timely or immediate response from the nurses to support me with the symptoms. This is a great benefit that they [the nurses] are alert, and as soon as we send a notification, we can immediately receive care. (BCP33, 30 years old, bachelor’s degree, CT)

(B2)

The recommendations have been very clear and very simple… …these are things that I started doing as habits already in my life and I have improved a lot. (BCP16, 57 years old, high school, RT)

(B3)

I received an email and a follow-up message through WhatsApp, because I don’t answer phone calls from unknown numbers. (BCP3, 50 years old, postgraduate, RT)

(B4)

I think the nurses are extremely attentive and friendly; I received a lot of attention from them. …They were very kind; their voice was cheerful, making us feel well. (BCP23, 70 years old, high school, RT)

Theme C: protection, accompaniment and support of women during their treatment by IMSS and their health professionals

Women highlighted that (C1) ePRO intervention generates a feeling of protection and support from the IMSS and their health professionals, making them feel they are not alone in fighting cancer.

(C1)

…when the nurse spoke to me [on the phone] for the first time, I felt very protected by the medical center because as strong as I can be, I always [have] some doubt, some fears, …so for me, it was a lot of protection knowing that I was not alone. (BCP18, 61 years old, high school, RT)

Both women and health professionals commented that recording symptoms in the ePRO application and its follow-up by the study nurses represent important assistance, ‘accompaniment’, in women’s words. For them, this accompaniment included (C2) responding to the women’s health-related needs to resolve any doubts from home, avoiding unnecessary travel to the hospital and providing recommendations helpful for symptom relief and (C3) being listened to and receiving emotional support by the nurses.

(C2)

[The ePRO intervention], it helps not going to the doctors and telling them “I have a headache; I have skin irritation today.” It helped me a lot to resolve the minor issues and have guidance from home. (BCP32, 49 years old, secondary school, RT)

…unfortunately, at IMSS, there is a large population [of cancer patients] under treatment, and sometimes [physicians] do not have time to explain each symptom fully. Therefore, I think the application helps patients a lot by resolving their doubts since many have doubts about the treatment they receive and its adverse effects… (HP3, 35 years old, woman, oncologist)

(C3)

We need someone to listen to us even when we feel sad, and the application helps us by listening to us… (BCP20, 40 years old, secondary school, CT)

Many of the patient’s needs are emotional; they need to be listened to, they need someone to give them that accompaniment, because sometimes it is not easy for them to express it [those needs] to the family or friends, because they don’t want to worry them… (HP2, 28 years old, woman, nurse)

Generally, all women expressed satisfaction with the ePRO intervention, suggesting recommending it to other women.

Theme D: facilitation of physician work by providing individualised, standardised and evidence-based guidance

Furthermore, health professionals noted that follow-up of women’s symptoms and supportive care needs by trained nurses translates into (D1) individualised, standardised and evidence-based guidance. This is because each patient’s situation is assessed individually, and recommendations are provided based on evidence-based clinical algorithms. This guidance of patients by nurses (D2) facilitates the physicians’ work by providing information and non-pharmacological recommendations that can be performed at home, thus involving patients in their self-care that can reinforce adherence to pharmacological treatment.

(D1)

…this app helps us to provide individualized guidance, as to address each alert, a brief but detailed assessment is conducted to better understand patient’s problems and provide best recommendations based on the scientific evidence. (HP2, 28 years old, woman, nurse)

(D2)

…When patients are better informed, they are more likely to adhere to the treatment, and as a physician, this benefits your medical practice. …sometimes, when the symptoms are not properly explained to the patients, they prefer to abandon or are irregular with the treatments, which in the long run makes treatment objectives difficult to achieve. (HP6, 43 years old, man, radiation oncologist)

It is crucial that the patient is committed to the treatment and takes co-responsibility. Typically, patients tend to leave the responsibility solely to the physician. However, this application promotes co-responsibility and self-care, facilitating follow-ups, appointment attendance. and other related aspects. The application covers it very well. This, in turn, makes the doctor’s job much easier. (HP8, 42 years old, man, head of oncology service)

Theme E: internet recharge as a support for women with a precarious economic situation

Several women have found internet recharge to their cell phones to be helpful in managing financial difficulties that arise from their illnesses.

The truth is that it’s really helpful to receive a recharge because, in my case, I rely on my salary. However, due to my disability, my salary is very low right now. So, sometimes I don’t have enough money to put credit on my phone. Therefore, the provided recharge has been very useful. (BCP25, 48 years old, high school, CT)

However, multiple participants reported that they did not find the internet recharge very useful as they already had access to internet services on their mobile phones or at home, while two women even declined this benefit.

I gave up that benefit [of telephone recharge]. I explained to the lady who invited me to participate that I normally have Wi-Fi at home and work, where I normally stay, and where I could use the application, so recharge support was unnecessary. (BCP17, 52 years old, bachelor’s degree, RT)

Research area: II. barriers to implementing the ePRO digital intervention

Barriers to implementing the ePRO digital intervention were reported at the individual level (women), intervention level (application+follow-up) and organisational level (IMSS).

II.1. Barriers at the individual level

Theme F: digital illiteracy generates difficulties and the need for help in using the ePRO application, mainly in women with low education and older age

At the individual level, some women and healthcare professionals have expressed that they faced difficulties in using the ePRO application due to unfamiliarity with digital technologies. As a result, some women had to seek support from study nurses and their families to use the application, especially older women with less education.

Yes, I needed support because I found it difficult to use the technology on my own. My daughter and the nurse were the ones who helped me. As a matter of fact, I couldn’t perform those actions [use the ePRO App] on my own because I didn’t have any schooling, and the truth is, I really can’t do it; so, that’s why my daughter assisted me. (BCP34, 61 years old, no schooling, CT)

Digital illiteracy. …many women, even those with telephones, often only use them to make calls. As a result, explaining to them how to install access and use the [ePRO] application has sometimes been complicated. This has led to a certain dependence on us, nurses, or family to help them constantly access the application. (HP2, a 28-year-old, woman, nurse)

Theme G: situations of irregular use of the ePRO application

Several women who participated in the study reported that they did not use the ePRO application regularly for different reasons. Some of them (G1) did not have any symptoms or support needs to report. Others (G2) only had mild symptoms or the same symptoms as the previous week, which made them feel that there was no need to record them. Some women (G3) had symptoms that limited their daily activities such as fatigue or pain, which made it difficult for them to use the application consistently. Finally, some women simply (G4) forgot to use the application or prioritised other activities. It’s worth noting that the study nurses identified similar situations of irregular use of the ePRO application.

(G1)

There were times when I didn’t have symptoms, …in those moments, the truth is, I didn’t see much point in answering that I hadn’t had symptoms. (BCP6, 35 years old, bachelor’s degree, CT)

(G2)

…because they were very mild symptoms, which were controlled with the medication, so, I didn’t see it as necessary to send [the alert] that I had mild symptoms. (BCP25, 48 years old, high school, CT)

I decided not to do it [not record symptoms], because my symptoms were still the same as the previous week and I didn’t see much reason to record them again. …I don’t know if weekly is the best frequency, because what I notice is that there are symptoms that are very repetitive or that take time to go away, such as skin irritation or numbness in the feet. Therefore, the periodicity of a week is too short, perhaps it should be every fifteen days. (BCP17, 52 years old, bachelor’s degree, RT)

(G3)

On the third day of chemotherapy, I was too fatigued to turn on my computer [and use the application]. (BCP48, 39 years old, bachelor’s degree, CT)

(G4)

Suddenly I forgot that I had to register [my symptoms] every week, as I didn’t have the habit. (BCP17, 52 years old, bachelor’s degree, RT)

II.2. Barriers at the intervention level

In addition to barriers at the individual level, women and health professionals reported some barriers at the intervention level.

Theme H: need to adjust the duration and schedule of the recording symptoms and follow-up

Some women who were undergoing CT treatment emphasised the importance of (H1) delaying the start or extending the individual use of the ePRO intervention because they experienced adverse effects several weeks after beginning the treatment. They also mentioned the (H2) need for nurses to provide support during nights and weekends since accessing medical services during these times is difficult.

(H1)

I think that, perhaps, in the beginning, when they give us access to the [ePRO] application, it should be after starting our chemotherapy so that we can have more time to benefit [from its use]. …Well, my symptoms started practically two and a half to three months after I began chemotherapy; therefore, I couldn’t use it [the application, when I needed it the most due to the six week follow-up of the pilot study]. (BCP6, 35 years old, bachelor’s degree, CT)

(H2)

The downside is that there is no support available on weekends or holidays. Obviously, we can’t tell our bodies, ‘Don’t feel bad on the weekend’, so this is one of the disadvantages. (BCP48, 39 years old bachelor’s degree, CT).

At the same time, the majority of health providers have suggested that (H3) the follow-up duration for CT and RT patients should be different based on the duration and adverse effects of treatment. They agreed that a 6-month follow-up would be appropriate for CT but excessive for patients receiving RT due to its duration of 1 month, and that once treatment is finished, adverse effects do not last long. In addition, they recommended (H4) recording symptoms according to each patient’s needs as an alternative to weekly recording, which could make follow-up easier.

(H3)

Six months of chemotherapy treatment is enough because we are including patients in locally advanced stages. This treatment is a scheme of eight cycles every 21 days for six months. In radiotherapy, the management of symptoms generally impacts during the acute phase. Six months for radiotherapy is excessive. Usually, [the adverse] effects occur in the first two months [of radiotherapy] to be modified by medical interventions. (HP10, 34 years old, man, medical oncologist)

(H4)

…I feel that maybe the fact that it is weekly [the recording of symptoms] does make it heavy for the patients. …maybe it will be [more practical] when they need it most and require it… (HP1, 27 years old, woman, nurse)

Theme I: long questionnaires make evaluations difficult

Some women found the evaluation questionnaires to be lengthy and time-consuming to complete. They suggested reducing the number of questions. This concern applied to the questionnaires used for evaluation, not the primary intervention content.

The number of questions in the questionnaires, mainly in the quarterly reports [baseline and final evaluation]. The weekly ones [registers] are quick to complete, but the quarterly ones are quite lengthy; maybe they [the questions] in the quarterly reports could be more concise and fewer in number. (BCP17, 52 years old, bachelor’s degree, RT)

II.3. Barriers at the institutional level

In addition, health professionals identified barriers at the organisational level.

Theme J: shortage of oncology physicians and nurses limits the feasibility of their participation in this intervention

Some chiefs of oncology services and doctors commented that in IMSS hospitals, there is a shortage of nurses and physicians specialising in oncology. This situation may complicate the participation of these personnel in the digital intervention and the implementation of the ePRO intervention may become unfeasible in IMSS. Therefore, a greater budget may be required for the hiring of health personnel for the ePRO intervention.

There is not enough nursing staff; we would need to hire more staff because right now it is insufficient, and this activity does require time dedicated to patients. And right now, with the staff we have, it would be difficult to implement it because there is still a lack of regular staff [in the hospital], and adding one more task to their workload will affect the usual care provided to patients. …it would be a matter of budget concern to hire the nurses who will work with this program; therefore, I think the barrier would be the availability of nursing staff. (HP4, 42 years old, man, chief of oncology services)

We are very few oncologists; we have only half the necessary oncologists and no oncologically-knowledgeable nursing staff, so that would be an important barrier. (HP10, 34 years old, man, medical oncologist)

Theme K: the activities established in the job description and contract, and rotation of the nursing staff can negatively affect nurses’ acceptance of the ePRO intervention

Some interviewees shared their concerns about the nursing staff’s acceptance of the ePRO because the institution’s job contract and internal job description dictate clinical activities for each category of health personnel, which do not currently include phone counselling of patients by nurses.

I am not sure how many nurses would be willing to accept [to participate in the intervention], given the job description. …I believe that the main barrier lies on the nursing side. I am concerned that when it comes time to rotate the nursing staff in charge of the [ePRO] area as part of the hospital’s internal job rotation, the new nurse may not want to perform phone counseling, and the contract will protect him [the new nurse]. (HP8, 42 years old, man, chief of oncology services)

However, in general, most of those interviewed believed the intervention would be well-received, given doctors’ and nurses’ commitment to patients.

Theme L: nurses do not prescribe medicines

In the IMSS, nurses are not authorised to prescribe medication to patients. Therefore, during the study, the nurses provided only non-pharmacological recommendations. However, some women and nurses pointed out that this approach had a drawback. When the non-pharmacological recommendations failed to reduce the adverse effects, patients had to go to the emergency room or wait for the next consultation with the oncologist.

The girls [nurses] are very efficient and super kind in caring for and listening to all our symptoms, but they can’t do much, because they can’t recommend us medicines, they can only help us with palliative care. (BCP17, 52 years old, bachelor’s degree, RT)

Some women have expressed that they would like to have recommendation about some medications, and when you tell them that the intervention is not focused on that, they have taken it the wrong way… (HP2, 28 years old, woman, nurse)

Research area: III. suggestions to improve ePRO intervention and make its implementation more feasible and useful

We asked women and health professionals about their suggestions to improve ePRO intervention and make its implementation more feasible and useful.

Theme M. ‘A work team comprising nursing staff must be assembled and trained’ and supported by physicians

Some physicians and chiefs of oncology services suggested the creation and implementation at IMSS a team of nurses trained to provide remote care and supported by oncologists during follow-up, to handle complex situations that nurses may not be able to resolve. The participants have also suggested coordinating the schedules of oncology physicians to identify times when they can support the programme, yet some healthcare professionals feel that an oncologist’s involvement is unnecessary.

…I believe that an entire team needs to be put together, mainly comprising nursing staff, who will be responding. In the First-World hospitals, the consultation process is very divided. Generally, when a patient visits a doctor, he has an interview with healthcare personnel, mainly a nurse. They are the ones who capture if patients had toxicity and if they had any adverse events, and when the patient meets the doctor, the nurses report the results they have obtained. The decision to continue with chemotherapy or make changes in the treatment is made by the oncologist. Then the nurse returns to explain all the discomfort that chemotherapy can cause. (HP4, 42 years old, man, chief of oncology services)

If the nurses have any doubts, they can rely on us, the oncologists, to assess whether further adjustments to the treatment are necessary. However, I believe that they are highly qualified. (HP3, 35 years old, woman, medical oncologist)

Theme N: training of a general practitioner to assist in the follow-up of women with breast cancer who need general pharmacological recommendations

A chief of oncology services emphasised that due to the shortages of oncologists at IMSS, general practitioners can be trained to support nurses in monitoring patients’ symptoms, especially for pharmacological treatment of adverse events of CT or RT.

It would be a waste to have an oncologist [in the ePRO program] due to the oncologists’ shortage in IMSS. However, a general practitioner can be trained to provide guidance on supportive medications for symptoms treating. This is similar to call centers, where patients report symptoms and [the call center workers] who are not specialists are trained to provide interventions. It would be a waste of specialist resources answering phones, but a general practitioner can be trained to do this intervention. (HP4, 42 years old, man, chief of oncology services)

Theme O: enabling oncology consultation by bringing together information from the ePRO application symptoms registry and IMSS health records

The majority of healthcare professionals identified that integrating information from the ePRO application symptom registry into institutional electronic health records would be highly beneficial. This would allow physicians to track the evolution of patients between consultations, making clinical decisions more efficient.

It would be highly advisable to combine data from the [IMSS] health records and the [e-PRO] application symptoms registry because when opening the health record, there would be the information the patient reported in the application, the consultation would be more agile. …So if all oncologists would have access to the toxicities and adverse events or symptoms presented by the patient, then it would be highly recommended for the entire IMSS. (HP4, 42 years old, man, head of oncology service)

As a physician, when you review the electronic health record, you would not only see what you did and recommended, but you would also see what has been happening to the patient or what the patient reports. It would be a huge help for the physician to make a clinical decision. (HP6, 43 years old, man, radiation oncologist)

Discussion

The present study identified that both women and health professionals perceived multiple benefits of the ePRO intervention, characterised by the easy-to-use user-friendly responsive web application, user-centred skills of nurses, the usefulness of the intervention to resolve women’s doubts from home and generate the feeling of protection, accompaniment and support from health professionals and IMSS, as well as facilitation of the physician work. These results are in line with qualitative studies that evaluated the feasibility of other e-Health interventions for patients with breast cancer undergoing CT in other countries.^26–28

The perceived benefits of the present intervention were also reflected in the reasonable recruitment rate, high retention rate, decrease in the supportive care needs and breast symptoms and increase in global quality of life, justifying further RCT. These results are in line with other ePRO implementations around the world.^29–35

At the same time, several barriers to successful ePRO implementation at individual, intervention and institutional levels were identified, suggesting improvements to the RCT protocol methods. Initially, we conducted the pilot study in one principal IMSS oncology hospital, but we encountered difficulties in recruiting patients at a steady pace due to the small number of patients with stage I–III breast cancer initiating CT or RT. This finding was unexpected, as previous studies from this hospital showed that over 85% of patients with breast cancer are diagnosed in clinical stages I–III, and over 60% of them receive neoadjuvant or adjuvant CT.³⁶ To overcome this issue, we decided to invite two additional hospitals to participate in the study, expanding our pool of potential participants and improving study generalisability.³⁷

Additionally, we identified a need to change the eligibility criteria by focusing recruitment on patients with CT and extending the recruitment period from 2 weeks after starting CT to 6 weeks and not including patients initiating RT. This decision was based on feedback from interviews with women and health professionals. They suggested that at IMSS, RT for patients with breast cancer was always indicated after CT, and the duration of RT was 1 month, with adverse effects lasting between 1 and 2 months. In contrast, the duration of CT and its adverse effects was around 6 months. Therefore, the proposed full intervention duration of 9 months of follow-up would be appropriate for those starting CT and would include patients who receive RT after CT.

Moreover, to simplify follow-up, women and nurses suggested recording symptoms according to individual needs rather than weekly. As a result, we consider requesting weekly symptom recording during the first month, with reminders and then allowing patients to record symptoms based on their needs and switching reminders to every 2 weeks. In addition, to provide assistance to women with low education and older age who face challenges in using the ePRO application, as well as those with severe symptoms, we will recommend and offer training to their family caregivers on how to use the ePRO application. Also, as recommended by the health professionals, we have decided to include and train two general practitioners who will assist in the follow-up of women with breast cancer, providing general pharmacological recommendations to the patients. However, due to research funding constraints, we are unable to address the need to provide nurses’ support at night and on weekends and support with telephone-internet recharges for women in a precarious economic situation.

Among the study’s strengths is that it incorporated a qualitative approach, which helped us to comprehend the perceived advantages and obstacles of ePRO intervention and opportunities for improvement. Another strength is the high retention rate, which is attributable to the user-friendly application, user-centred follow-up and the caregiver’s involvement in assisting women who are not familiar with technology in using the ePRO application.

Among the study limitations is the non-randomised nature of the pilot study that prevents us from drawing conclusions about the effectiveness of the ePRO intervention. Furthermore, although the study included three hospitals, most participants (80%) belonged to the oncology hospital where the study was started, which may limit the generalisation of the results.

Conclusion

The present study identified multiple benefits of the ePRO intervention perceived by women and health professionals and encouraging prelaminar results related to high retention rate, decrease in the supportive care needs and breast symptoms and increase in global quality of life, justifying further RCT. The study also revealed several barriers to successful ePRO implementation at individual, intervention and institutional levels and suggested improvements to the RCT protocol methods.

SECS (CVU 822323) thanks the Programa de Maestría y Doctorado en Ciencias Médicas Odontológicas y de la Salud de la Universidad Nacional Autónoma de México where he is enrolled, for supporting his studies, as well as Consejo Nacional de Humanidades, Ciencias y Tecnologías (CONAHCYT).

Data availability statement

Data are available upon reasonable request. De-identified data will be available to secondary researchers whose proposed research has received institutional review board approval once a trial is completed and its primary results are published and for 5 years thereafter. The data will be available upon reasonable request from Dr Svetlana V. Doubova, email: [email protected].

Ethics statements

Patient consent for publication

Not applicable.

Ethics approval

The National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants gave informed consent to participate in the study before taking part.

Footnote

X @zwittang, @AdMoGu

Contributors SECS and SVD conceptualised the study, supervised the fieldwork, conducted quantitative and qualitative data analysis, interpretation of the study results and prepared the first draft of the manuscript. IPM-V conducted in-depth interviews, participated in the qualitative data analysis and data interpretation. HL participated in the study conceptualisation and methodological improvements, obtained funding from the University of California San Francisco (UCSF) Global Cancer Program at the Helen Diller Family Comprehensive Cancer Care Center, critically reviewed the manuscript for significant intellectual content. RGA, RV-V, AKDB, LL-M, WJMP, JGNC, ADH-L, RZV, VM-O, VJV-Z, AJM-J, AG-G, EIT-G, RS-R, JA-G and MEA-A contributed to the recruitment of the study participants, participated in in-depth interviews and critically reviewed the manuscript for significant intellectual content. MZ-T and AM participated in the study conceptualisation and critically reviewed the manuscript for significant intellectual content. All authors read and approved the final manuscript. SVD is responsible for the overall content of the article as the guarantor.

Funding The project received an award from the University of California San Francisco (UCSF) Global Cancer Program at the Helen Diller Family Comprehensive Cancer Care Center and the UCSF Academic Senate Committee to support the pilot testing of the intervention and a grant funding from the Research Funding Program of the Mexican Institute of Social Security as part of the 2023 IMSS Call for funding research projects focus on Priority Health issues, Vulnerable Populations and Emerging Issues to finance the clinical trial. N/A for the award/grant number for the UCSF and the IMSS.

Competing interests None declared.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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