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 BackgroundAdherence 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. MethodsThe 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. DiscussionThis 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. Trial registrationISRCTN: 12027752. Reigstered 24 December 2020, https://doi.org/10.1186/ISRCTN12027752

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Lifestyle and quality of life in patients with early-stage breast cancer receiving adjuvant endocrine therapy

Current Opinion in Oncology ◽

10.1097/cco.0000000000000781 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Antonio Di Meglio ◽

Davide Soldato ◽

Daniele Presti ◽

Ines Vaz-Luis

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Endocrine Therapy ◽

Early Stage ◽

Adjuvant Endocrine Therapy ◽

Early Stage Breast Cancer

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Role of individualized intervention(s) on quality of life (QoL) and adherence to adjuvant endocrine therapy in premenopausal women with early-stage breast cancer (bc): MyChoice study

Annals of Oncology ◽

10.1093/annonc/mdz240.113 ◽

2019 ◽

Vol 30 ◽

pp. v98

Author(s):

S. Ahmed ◽

H.I. Chalchal ◽

L. Dwernychuk ◽

N. Iqbal ◽

M. Salim ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Endocrine Therapy ◽

Early Stage ◽

Premenopausal Women ◽

Adjuvant Endocrine Therapy ◽

Early Stage Breast Cancer ◽

Individualized Intervention

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Investigating Associations Between Health-Related Quality of Life and Endocrine Therapy Underuse in Women With Early-Stage Breast Cancer

Journal of Oncology Practice ◽

10.1200/jop.2016.018630 ◽

2017 ◽

Vol 13 (5) ◽

pp. e463-e473 ◽

Cited By ~ 3

Author(s):

Laura C. Pinheiro ◽

Stephanie B. Wheeler ◽

Katherine E. Reeder-Hayes ◽

Cleo A. Samuel ◽

Andrew F. Olshan ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Endocrine Therapy ◽

Early Stage ◽

Health Related Quality ◽

Logistic Regression Models ◽

Increased Risk ◽

Related Quality ◽

Health Related

Purpose: Endocrine therapy (ET) underuse puts women at increased risk for breast cancer (BC) recurrence. Our objective was to determine if health-related quality of life (HRQOL) subgroups were associated with underuse. Methods: Data came from the third phase of the Carolina Breast Cancer Study. We included 1,599 women with hormone receptor–positive BC age 20 to 74 years. HRQOL was measured, on average, 5 months postdiagnosis. Subgroups were derived using latent profile (LP) analysis. Underuse was defined as not initiating or adhering to ET by 36 months postdiagnosis. Multivariable logistic regression models estimated adjusted odds ratios (ORs) between HRQOL LPs and underuse. The best HRQOL LP was the reference. Chemotherapy- and race-stratified models were estimated, separately. Results: Initiation analyses included 953 women who had not begun ET by their 5-month survey. Of these, 154 never initiated ET. Adherence analyses included 1,114 ET initiators, of whom 211 were nonadherent. HRQOL was not significantly associated with noninitiation, except among nonchemotherapy users, with membership in the poorest LP associated with increased odds of noninitiation (adjusted OR, 5.5; 95% CI, 1.7 to 17.4). Membership in the poorest LPs was associated with nonadherence (LP1: adjusted OR, 2.2; 95% CI, 1.2 to 4.0 and LP2: adjusted OR,1.9; 95% CI, 1.1 to 3.6). Membership in the poorest LP was associated with nonadherence among nonchemotherapy users (adjusted OR, 2.1; 95% CI, 1.2 to 5.1). Conclusion: Our results suggest women with poor HRQOL during active treatment may be at increased risk for ET underuse. Focusing on HRQOL, a modifiable factor, may improve targeting of future interventions early in the BC continuum to improve ET initiation and adherence and prevent BC recurrence.

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