The BrEasT cancer afTER-CARE (BETTER-CARE) program, a cluster-randomized controlled trial, is underway in Germany to evaluate an innovative approach to breast cancer follow-up care. The study, which began in March 2023 and is expected to run until June 2025, involves 30 breast cancer centers and aims to improve the health-related quality of life for patients after curative primary treatment.
Study Design and Participants
The BETTER-CARE trial is designed as a parallel-arm cluster-randomized controlled trial. Participating Breast Cancer Centres were selected based on German Cancer Society certification and ability to export routine data via Onkozert® software. Inclusion criteria include breast cancer patients aged 18 or older who have completed primary treatment. Exclusion criteria involve metastatic breast carcinoma diagnosis or lack of access to a mobile device with internet connection. Patients already participating in similar digital follow-up programs are also excluded.
Intervention Components
Patients in the control group receive usual care according to German clinical guidelines. The intervention group benefits from a complex intervention developed using the Medical Research Council (MRC) framework. This includes structural components such as an intersectoral and multidisciplinary network of local healthcare providers coordinated by the Breast Cancer Centre, and an electronic health record (myoncare®) used by both the Breast Cancer Centre and primary follow-up care providers.
The behavioral components consist of regular assessment of patient needs, individual use of a follow-up care passport, and individual use of digital applications and interventions. Trained nurses (BETTER-CARE-Nurse) and physicians (BETTER-CARE-Coordinator) at the Breast Cancer Centre conduct regular needs assessments via phone calls. Low-risk patients are contacted every 6 months, while high-risk patients are contacted every 3 months. If patients do not use the app, phone call frequency increases.
Digital Tools and Support
The BETTER-CARE trial incorporates two digital applications to support patients. The PIA (“Patient-informiert-interaktiv-Arzt”) Health app is used to assess well-being, with low-risk patients assessed every 3 months and high-risk patients assessed weekly. The app also facilitates communication with the Breast Cancer Centre and offers a 4-week fatigue intervention based on the National Comprehensive Cancer Network guideline on fatigue. Additionally, an ACTonCancer intervention, based on acceptance and commitment therapy (ACT), is available for patients with high psychological distress (GAD-7/PHQ-8 score ≥ 10).
Primary and Secondary Outcomes
The primary outcome is health-related quality of life (HRQoL), measured by the EORTC QLQ-C30 Global health status/QoL scale. Secondary outcomes include quality of life, treatment adherence, treatment consequences (e.g., fatigue, neurotoxicity), psychological comorbidities (e.g. anxiety, depression), guideline-adherent follow-up examinations, participation in work life, rehospitalization, progression-free survival, and patient satisfaction. A health economic evaluation will also investigate follow-up costs in the first year.
Statistical Analysis and Sample Size
The study aims to recruit a total of 1140 patients across 30 clusters, with approximately 38 patients per cluster. Evaluations will be conducted according to modified intention-to-treat. The primary hypothesis will be tested via a univariate linear mixed effects model, adjusting for intra-cluster correlations. Multivariable linear mixed effects models will adjust for pre-defined confounders such as age and risk of recurrence. The concept of evaluating economic effects and costs is based on an incremental analysis comparing intervention to control.
Pilot Phase and Process Evaluation
A pilot phase was conducted to record the duration of the baseline survey and the implementation of intervention components. A process evaluation is also being carried out to examine the implementation of the study intervention, including interviews with patients and healthcare professionals.
