Abstract

Background

About 30% of cancer survivors suffer from chemotherapy-induced peripheral neuropathy (CIPN) ≥6 months after completion of chemotherapy. This condition, for which treatment options are scarce, comes with limitations in daily life functioning and decreased quality of life. The current study examines the effectiveness of an online self-help intervention based on Acceptance and Commitment Therapy (ACT) in comparison to a waiting list condition (WLC) to deal with CIPN. In addition, it examines which factors moderate effects and to what extent the effects differ between guided and unguided ACT intervention.

Methods

A two-parallel, non-blinded randomized controlled trial (RCT) will be carried out. Adult cancer survivors who experience painful CIPN for at least 3 months and completed chemotherapy at least 6 months ago will be recruited (n=146). In the intervention condition, participants will follow an 8-week self-management course containing 6 modules regarding psychoeducation and ACT processes, including therapeutic email guidance. By means of text and experiential exercises, supplemented with illustrations, metaphors, and audio files, people will learn to carry out value-oriented activities in their daily life with pain. Participants will learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Participants in the WLC will be invited to follow the intervention without therapeutic guidance 5 months after start. Pain interference is the primary outcome, while psychological distress, quality of life, CIPN symptom severity, pain intensity, psychological flexibility, mindfulness skills, values-based living, and pain catastrophizing will serve as secondary outcomes. All outcome measures will be evaluated at inclusion and baseline, early-intervention, mid-intervention, post-treatment, and 3- and 6-month post-treatment. Qualitative interviews will be conducted post-treatment regarding experiences, usage, usability, content fit, and satisfaction with the intervention.

Discussion

This study will provide valuable information on the effectiveness of an online self-help intervention based on ACT versus WLC for chronic painful CIPN patients.

Trial registration

ClinicalTrials.gov NCT05371158. Registered on May 12, 2022.

Protocol version: version 1, 24-05-2022

Details

Title
Effectiveness of the online Acceptance and Commitment Therapy intervention “Embrace Pain” for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial
Author
van de Graaf, Daniëlle L. 1   VIAFID ORCID Logo  ; Mols, Floortje 1 ; Trompetter, Hester R. 2 ; van der Lee, Marije L. 3 ; Schreurs, Karlein M. G. 4 ; Børøsund, Elin 5 ; Nes, Lise Solberg 6 ; Smeets, Tom 2 

1  Tilburg University, CoRPS - Center of Research on Psychological disorders and Somatic Diseases, Department of Medical and Clinical Psychology, Tilburg, The Netherlands (GRID:grid.12295.3d) (ISNI:0000 0001 0943 3265); Netherlands Comprehensive Cancer Organisation (IKNL), Department of Research, Utrecht, The Netherlands (GRID:grid.470266.1) (ISNI:0000 0004 0501 9982) 
2  Tilburg University, CoRPS - Center of Research on Psychological disorders and Somatic Diseases, Department of Medical and Clinical Psychology, Tilburg, The Netherlands (GRID:grid.12295.3d) (ISNI:0000 0001 0943 3265) 
3  Tilburg University, CoRPS - Center of Research on Psychological disorders and Somatic Diseases, Department of Medical and Clinical Psychology, Tilburg, The Netherlands (GRID:grid.12295.3d) (ISNI:0000 0001 0943 3265); Helen Dowling Institute, Centre for Psycho-Oncology, Scientific Research Department, Bilthoven, The Netherlands (GRID:grid.470968.4) (ISNI:0000 0004 0401 8603) 
4  University of Twente, Department of Psychology, Health & Technology, Centre for eHealth & Well-being Research, Enschede, The Netherlands (GRID:grid.6214.1) (ISNI:0000 0004 0399 8953) 
5  Oslo University Hospital, Department of Digital Health Research, Division of Medicine, Oslo, Norway (GRID:grid.55325.34) (ISNI:0000 0004 0389 8485); University of South-Eastern Norway, Faculty of Health and Social Sciences, Drammen, Norway (GRID:grid.463530.7) (ISNI:0000 0004 7417 509X) 
6  Oslo University Hospital, Department of Digital Health Research, Division of Medicine, Oslo, Norway (GRID:grid.55325.34) (ISNI:0000 0004 0389 8485); Mayo Clinic, Department of Psychiatry and Psychology, College of Medicine and Science, Rochester, USA (GRID:grid.66875.3a) (ISNI:0000 0004 0459 167X); University of Oslo, Institute of Clinical Medicine, Faculty of Medicine, Oslo, Norway (GRID:grid.5510.1) (ISNI:0000 0004 1936 8921) 
Pages
642
Publication year
2022
Publication date
Dec 2022
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-022-06592-3
ProQuest document ID
2808564023
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.