Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial

Abstract

Background

Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. Previous interventions focused on educating women to enhance adherence have proved minimally effective. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to enhance medication decision-making and quality of life by targeting a broader range of factors, including side-effect management and psychological flexibility. This study aims to establish key trial parameters, assess the acceptability of the intervention and the extent to which it can be delivered with fidelity, and to demonstrate “proof of principle” regarding its efficacy on primary and process outcomes.

Methods

The ACTION intervention includes an individual 1:1 ACT session followed by three group sessions involving 8–10 women and two practitioner psychologists. Participants are also provided with access to a website containing evidence-based methods for self-managing side-effects. The ACT sessions were adapted during the COVID-19 pandemic to be remotely delivered via video conferencing software. To evaluate the feasibility and acceptability of this intervention, a multi-site, exploratory, two-arm, individually randomised external pilot trial with a nested qualitative study will be undertaken. Eighty women with early stage breast cancer prescribed adjuvant endocrine therapy will be randomised (1:1) to receive treatment as usual or treatment as usual plus the ACTION intervention. The planned future primary outcome is medication adherence assessed by the ASK-12 measure. Progression to a phase III RCT will be based on criteria related to recruitment and follow-up rates, acceptability to patients, competency and fidelity of delivery, and proof of principle for change in medication adherence.

Discussion

This external pilot trial will be used to ascertain the feasibility of undertaking a future phase III RCT to definitively evaluate an ACT-based intervention to support medication taking behaviour and quality of life in women with early stage breast cancer on adjuvant endocrine therapy.

Metadata

Item Type:	Article
Authors/Creators:	Smith, SG https://orcid.org/0000-0003-1983-4470 Ellison, R Hall, L Clark, J Hartley, S Mason, E https://orcid.org/0000-0002-0735-3007 Metherell, J Olivier, C Napp, V https://orcid.org/0000-0001-6726-2222 Naik, J Buckley, S Hirst, C Hartup, S Neal, RD Velikova, G https://orcid.org/0000-0003-1899-5942 Farrin, A https://orcid.org/0000-0002-2876-0584 Collinson, M https://orcid.org/0000-0003-3568-6455 Graham, CD
Copyright, Publisher and Additional Information:	© The Author(s) 2022. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Keywords:	Medication adherence, Breast cancer, Acceptance and Commitment Therapy, Pilot, Quality of life, Remote delivery, Group therapy, Video conferencing
Dates:	Published: December 2022 Published (online): 8 February 2022 Accepted: 19 January 2022
Institution:	The University of Leeds
Funding Information:	Funder Grant number Yorkshire Cancer Research Account Ref: 2UOLEEDS L417
Depositing User:	Symplectic Publications
Date Deposited:	18 Feb 2022 10:55
Last Modified:	27 Jun 2023 13:41
Status:	Published
Publisher:	BMC
Identification Number:	10.1186/s40814-022-00985-6
Related URLs:	PubMed URL
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:183757

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Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial

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