CONNECT: Combining Navigation, Networks, and Electronic monitoring to improve endoCrine Therapy adherence - PROJECT SUMMARY: Endocrine therapy (ET) reduces the risk of breast cancer (BC) recurrence and mortality and is typically prescribed for 5–10 years for women with hormone receptor–positive (HR+) BC. However, ET often causes side effects that negatively impact quality of life (QOL) and contribute to high rates of non-adherence (27–72%). These challenges exacerbate differences in outcomes among various population groups that are not fully explained by tumor biology or treatment. Whereas interventions that have focused solely on individual-level barriers (e.g., limited knowledge of symptom management) have shown limited success, approaches that address social connectedness, a multilevel construct reflecting the extent to which individuals have supportive relationships and participate in social interactions, may offer greater benefit in improving adherence and QOL. In our prior work, Enhanced Monitoring (EM), defined as standard of care (SOC; clinic visits every 3 months) + smart pill bottles (SPB), improved ET adherence compared with SOC alone at both 6 months (70.8% SOC vs 82.1% EM) and 12 months (53.1% SOC vs 69.5% EM). However, adherence still declined over time, indicating that monitoring alone is not sufficient for sustained adherence. Building on this, we developed CONNECT (Combining Navigation, Networks, and Electronic monitoring to improve endoCrine Therapy adherence), a multilevel intervention designed to provide a more comprehensive and sustainable approach. CONNECT integrates EM with navigator-led self-management education and skills training, social needs screening and linkage to resources, and social prescribing to culturally relevant peer and community programs. Grounded in Self-Determination Theory (SDT), CONNECT targets three basic psychological needs. To support autonomy, it uses motivational interviewing techniques to provide a clear rationale for ET, encourage choice, and promote elaboration. To strengthen competence, it offers navigator-led skills training in problem solving, communication, symptom management, and mobilizing social support. To enhance relatedness, it fosters connections across interpersonal, system and community levels. A total of 300 HR+ BC survivors will be randomized to (1) EM or (2) CONNECT (EM + patient navigation). AIM 1 evaluates the efficacy of CONNECT in improving ET adherence (primary outcome) and QOL (secondary outcome) at 6 months, and tests whether these effects are sustained at 12 months. AIM 2 assesses implementation outcomes (reach, effectiveness, adoption, implementation, maintenance) and the contextual factors influencing them. AIM 3 (exploratory) examines theory-informed mechanisms and moderators of intervention effects. CONNECT introduces a multilevel, clinic-community care model to support long-term adherence to endocrine cancer therapy. Findings will improve understanding of how social relationships influence adherence and quality of life in breast cancer and will inform the design of future interventions to promote adherence for other oral anticancer therapies and chronic disease treatments.
