Grant Number:	1R01CA303943-01A1 Interpret this number
Primary Investigator:	Arch, Joanna
Organization:	University Of Colorado
Project Title:	Randomized Trial of a Novel Intervention to Increase Endocrine Therapy Adherence Among Depressed Breast Cancer Survivors
Fiscal Year:	2026

ABSTRACT As oral anti-cancer treatments taken at home become increasingly common, improving outcomes for cancer survivors at risk of poor adherence is urgent. Depression, one of the most common risk factors for poor anti- cancer medication adherence, has been rarely addressed. Adjuvant endocrine therapy (AET)—one of the most widely prescribed oral anti-cancer medications in the US and globally—is taken daily for 5-10 years, reducing cancer recurrence by 40-50% for the 275,000 US women diagnosed annually with the most common form of breast cancer. AET has well-characterized side effects and predictors of adherence, making it an ideal target for adherence efforts. Despite its effectiveness, adhering to AET is challenging, especially for the one in three breast cancer survivors with depression. Depression predicts poor AET adherence and associated higher recurrence and mortality—yet almost no AET adherence efforts have targeted it. We address this gap by evaluating REACH+, an enhanced intervention that builds on findings from our original REACH intervention tested in an NCI-funded R21. REACH findings were promising but highlighted the need to directly address depression and manage AET side effects. REACH+ leverages personal values-based strategies from REACH along with novel strategies adapted from Positive Affect Treatment—a cutting-edge behavioral treatment for depression that outperforms previous approaches—which we adapted to reduce depression and boost positive AET associations among breast cancer survivors. These strategies will be delivered via well-piloted, online, self-paced sessions, supported by telehealth coaching from social workers in patients’ community cancer care clinics. REACH+ also integrates calls from advance practice providers in these community clinics to manage AET side effects, another major barrier to adherence, with calls guided by a personalized decision tree algorithm. This is the first known RCT to target AET adherence by treating depression and medication side effects in a single streamlined intervention, and one of the first embedded in community cancer clinics, where most US patients are treated. In a fully-powered RCT, we will compare REACH+ to well-piloted, Education-enhanced usual care (EUC) in 236 breast cancer survivors with clinically significant depression symptoms. We will assess short-term effects of REACH+ vs. EUC on AET daily adherence (primary outcome), AET persistence, medication side effects, depression, and quality of life (secondary outcomes) at post- treatment (Aim 1), as well as longer-term effects at 6-month follow-up (Aim 2). Theorized mechanisms for each intervention component will be evaluated to elucidate how the intervention works. AET adherence will be assessed objectively using Wisepill real-time monitoring devices, an approach we have expertise using in breast cancer. This study aims to advance science and practice to tackle depression—a long overlooked barrier to oral anti-cancer medication adherence—using a scalable, community-based approach.





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