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. 2025 May 26:14:e69855.
doi: 10.2196/69855.

ENABLE-App-Based Digital Capture and Intervention of Patient-Reported Quality of Life, Adverse Events, and Treatment Satisfaction in Breast Cancer: Protocol for a Randomized Controlled Trial

Thomas M Deutsch  1 , Léa L Volmer  2 , Manuel Feisst  3 , Laura Bodenbeck  1 , Kathrin Hassdenteufel  1 , Lara Tretschock  1 , Christiane Breit  1 , Stefan Stefanovic  4 , Armin Bauer  5 , Carolin Anders  6   7 , Lina Weinert  6   8 , Tobias Engler  2 , Andreas D Hartkopf  2 , Nico Pfeifer  9   10 , Pascal Escher  9   10 , Marc Mausch  9   10   11 , Oliver Heinze  12 , Marc Suetterlin  4 , Sara Y Brucker  2 , Andreas Schneeweiss  13   14 , Markus Wallwiener  15
Affiliations

ENABLE-App-Based Digital Capture and Intervention of Patient-Reported Quality of Life, Adverse Events, and Treatment Satisfaction in Breast Cancer: Protocol for a Randomized Controlled Trial

Thomas M Deutsch et al. JMIR Res Protoc. .

Erratum in

Abstract

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.

Keywords: HRQoL; breast cancer; eHealth apps; ePRO; electronic patient-reported outcomes; health-related quality of life.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Timepoints of questionnaire assessments (visits) depending on the therapy and therapeutic strategy. Adj. CT: adjuvant chemotherapy; Adj. ET: adjuvant endocrine therapy; CT: chemotherapy; EoCT: end of chemotherapy; NACT: neoadjuvant chemotherapy; OP: operation; POST-NACT/pNACT: postneoadjuvant chemotherapy.
Figure 2
Figure 2
Study design of the ENABLE trial: upon patient enrollment in the care portal, randomization is performed automatically using centralized block randomization. ePRO-CTCAE: electronic patient-reported outcome Common Terminology Criteria of Adverse Event; HRQoL: health-related quality of life; PRO: patient-reported outcome; PROMIS-29: Patient-Reported Outcomes Measurement Information System-29; QLQ-BR45: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-BR45; QLQ-C30: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-C30; R: 1:1 randomization; RPA: reactive patient-reported outcome assessment.
Figure 3
Figure 3
(A) RPA procedure with HRQoL screening via EQ-VAS, (B) symptom query, and psycho-oncological screening in case of a value <50 or a decrease of 10 % in comparison to the last EQ-VAS value. The symptom query is followed by (C) care advice, (D) an alarm for the care team via the “PIA” platform, and (E) educational content for the patient via the app. The images show the app representations for the patient. centralized block randomization. PRO-CTCAE: patient-reported outcome Common Terminology Criteria of Adverse Event; HRQoL: health-related quality of life; RPA: reactive patient-reported outcome assessment.
Figure 4
Figure 4
The home screen of the ENABLE app with representation of the different functions. ePROM: electronic patient-reported outcome measurement.
See this image and copyright information in PMC

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