Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors

Abstract

Background Oral anti-cancer treatments such as adjuvant endocrine therapies (AET) for breast cancer survivors are commonly used but adherence is a challenge. Few low-touch, scalable interventions exist to increase ET adherence. Purpose To evaluate the acceptability, feasibility, and initial efficacy of a low-touch, remotely-delivered values plus AET education intervention (REACH) to promote AET adherence. Methods A mixed-methods trial randomized 88 breast cancer survivors 1:1 to REACH or Education alone. Wisepill real-time electronic adherence monitoring tracked monthly AET adherence during a 1-month baseline through 6-month follow-up (FU) (primary outcome). Patient-reported outcomes were evaluated through 3- and 6-month FU (secondary). Multiple indices of intervention feasibility and acceptability were evaluated. Qualitative exit interviews (n = 38) further assessed participants’ perceptions of feasibility/acceptability and recommendations for intervention adaptation. Results The trial showed strong feasibility and acceptability, with an eligible-to-enrolled rate of 85%, 100% completion of the main intervention sessions, and “good” intervention satisfaction ratings on average. For Wisepill-assessed AET adherence, REACH outperformed Education for Month 1 of FU (p = .027) and not thereafter. Participants in REACH maintained high adherence until Month 4 of FU, whereas in Education, adherence declined significantly in Month 1. Conditions did not differ in self-reported adherence, positive affective attitudes, future intentions, or necessity beliefs. REACH trended toward less negative AET attitudes than Education at 3-month FU (p = .057) reflecting improvement in REACH (p = .004) but not Education (p = .809). Exploratory moderator analyses showed that average to highly positive baseline AET affective attitudes and oncologist-patient communication each predicted higher adherence following REACH than Education; low levels did not. Participants identified recommendations to strengthen the interventions. Conclusions REACH, a low-touch values intervention, showed good feasibility and acceptability, and initial promise in improving objectively-assessed AET adherence among breast cancer survivors (relative to education alone). Future research should target improving REACH’s tailoring and endurance.

Motivational Interviewing Counseling to Increase Endocrine Therapy Adherence in Diverse Patients

“…Patel and colleagues recently tested the effects of an outpatient pharmacy team-led intervention that reduced treatment delays in medication initiation, but did not directly assess longer-term adherence [ 31 ]. Non-counseling-based interventions have leveraged text message services for reminders, educational support, and electronic medication monitoring and feedback [ 32 , 33 ], but have had mixed results [ 34 ]. Other multicomponent intervention packages using intervention mapping and other stakeholder-engaged approaches have been developed and are being further evaluated [ 18 , 35 ].…”

A Systematic Review and Meta-Analysis of Interventions to Promote Adjuvant Endocrine Therapy Adherence Among Breast Cancer Survivors

“…[16][17][18][19][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] Comparatively few studies (n 5 8) used continuous measures of adherence. [39][40][41][42][43][44][45][46] Studies collected adherence data in various ways including self-report, medical chart records, prescription records, health insurance claims, electronic monitoring devices, and biological assays (urine or blood). Seven studies used more than one measure of adherence.…”

“…[16][17][18][19] Fifteen studies included women across the full trajectory of adjuvant treatment (0-51 years). 22,27,29,32,33,35,39,41,42,[44][45][46][48][49][50] One study included patients who had taken 4-5 years of tamoxifen at baseline and were eligible to continue with letrozole, 19 and two studies did not report any information regarding how long women had been taking AET. 18,21 Participant Selection on the Basis of Risk Factors for Nonadherence…”

“…A minority of studies (n 5 8) selected participants with a known risk factor for nonadherence: low income, 16,17,36 suboptimal baseline adherence or difficulties taking their medication, 29,32,39 significant AI-related pain, 44 or elevated AET distress about taking the medication or medication side effects. 45 Apart from studies that focused on low-income women, 16,17,36 no studies recruited participants on the basis of other known demographic risk factors for nonadherence (eg, age, race/ethnicity).…”

“Interventions to increase adherence to oral therapies in breast cancer patients: A systematic review based on the behavior change technique taxonomy”

“…Among these, social cognitive theory 71 was the more frequently applied, 36,37,46,48,49 followed by Cognitive Behavioral Therapy. 47,52,62,[72][73][74] Other interventions were based on the models of concordance and shared decision making, 66,75 the theory of planned behavior, 59,68,76 the health belief model, 38,53,77 the common-sense model of self-regulation, 59,78 the Acceptance and Commitment Therapy, 51,61,79 the Mindfulness-Based Stress Reduction, 53,80 and the self-affirmation theory. 51,81 Across the articles examined, the sample size varied between 27 and 7867, with a total of 28,528 BC patients.…”