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ENABLE-App-Based Digital Capture and Intervention of Patient-Reported Quality of Life, Adverse Events, and Treatment
Thomas M Deutsch1, Léa L Volmer2, Manuel Feisst3
1Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.
Background:
In recent years, breast cancer treatment has taken the path toward personalized medicine. Based on individual tumor biology, therapy tailored to the particular subtype of cancer is increasingly being used. The aim here is to find the most suitable therapy for the disease. However, the success of therapy depends to a large extent on the patient's adherence to treatment. This, in turn, depends on how the therapy is tolerated and how the treatment team cares for the patient. Patient-centered care seeks to identify and address the individual needs of each patient and to find the best form of care for that person.
Objective:
In order to improve comprehensive oncological care of patients with breast cancer, the ENABLE trial digitally recorded the health-related quality of life (HRQoL), adverse events (AEs), and patient satisfaction using a mobile smartphone app. The trial provided individualized responses to reported AEs and offered assistance. Additionally, it assessed the impact of a patient-reported outcome-based intervention across various therapy settings.
Methods:
Patients with breast cancer were eligible to participate in the study before neoadjuvant, adjuvant, postneoadjuvant, or palliative systemic therapy against breast cancer was initiated at the Heidelberg, Mannheim, and Tuebingen, Germany, university hospitals. After 1:1 randomization into an intervention and a control group, HRQoL assessments were performed at six fixed time points during the therapy using validated questionnaires. In the intervention group, HRQoL was also assessed briefly every week using a visual analog scale (EQ-VAS). In cases of significant deterioration, therapy-associated side effects were assessed in a graduated manner, recommendations were sent to the patient, and the treatment team was informed. Additionally, the app served as an "eHealth companion" for education, training, and organizational support during therapy.
Results:
Recruitment started in March 2021; follow-up was completed in February 2024. In total, 606 patients were enrolled, and 592 patients participated in the study. Enrollment was completed in September 2023, and the last visit was in February 2024. The first results are expected to be published in Q2 2025.
Conclusions:
Participation in the intervention group is expected to improve treatment satisfaction, adherence, detection, and timely treatment of critical AEs. The close-meshed, weekly, brief HRQoL assessment will also be tested as a screening tool to detect relevant side effects during therapy. The study offers a more objective HRQoL assessment across treatment strategies.
Trial Registration:
Deutsches Register Klinischer Studien DRKS00025611; https://drks.de/search/en/trial/DRKS00025611.
International Registered Report Identifier (Irrid):
DERR1-10.2196/69855.
Insights
The ENABLE trial used a smartphone app to monitor breast cancer patients' quality of life and side effects, aiming to improve treatment adherence and satisfaction. Early results suggest this digital approach enhances patient-centered care and timely intervention.
Area of Science:
- Oncology
- Digital Health
- Patient-Centered Care
Background:
- Personalized medicine is advancing breast cancer treatment, tailoring therapies to individual tumor biology.
- Treatment success hinges on patient adherence, influenced by therapy tolerance and healthcare team support.
- Patient-centered care emphasizes addressing individual needs for optimal treatment outcomes.
Purpose of the Study:
- To enhance oncological care for breast cancer patients through the ENABLE trial.
- To digitally record health-related quality of life (HRQoL), adverse events (AEs), and patient satisfaction using a mobile app.
- To assess the impact of a patient-reported outcome-based intervention on treatment across diverse settings.
Main Methods:
- The ENABLE trial enrolled 606 breast cancer patients across three German university hospitals.
- Patients were randomized 1:1 to an intervention or control group, with HRQoL assessed using validated questionnaires and a weekly visual analog scale (EQ-VAS) in the intervention group.
- The intervention group received individualized responses to reported AEs and support via a mobile app, which also served as an eHealth companion.
Main Results:
- Recruitment occurred between March 2021 and September 2023, with follow-up completed in February 2024.
- 592 patients participated in the study.
- First results are anticipated in Q2 2025.
Conclusions:
- The intervention is expected to improve treatment satisfaction, adherence, and the detection and management of critical AEs.
- Weekly HRQoL assessments via the app may serve as a screening tool for therapy-related side effects.
- The study aims to provide a more objective HRQoL assessment across various breast cancer treatment strategies.
