Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)

Area of Science:

• Oncology
• Digital Health
• Patient Self-Management

Background:

• Growing number of mHealth tools for breast cancer patients lack scientific evidence.
• Previous studies show mixed impacts of mHealth tools on users.
• OWise Breast Cancer app facilitates symptom self-monitoring and care management.

Purpose of the Study:

• To assess the impact of the OWise Breast Cancer mobile application on patient self-management.
• To evaluate the app's effect on patient activation in early-stage breast cancer patients.
• To determine the influence on quality of life, psychological distress, and healthcare resource utilization.

Main Methods:

• Randomized controlled trial comparing standard care with standard care plus OWise app.
• Participants (early-stage breast cancer) assessed using PAM-13 for patient activation at 3 months.
• Health-related quality of life, psychological distress, and NHS resource utilization tracked over 12 months.
• Data linked to an integrated care record; contamination in control group measured and mitigated.

Main Results:

• Primary outcome: patient activation at 3 months post-diagnosis (PAM-13 questionnaire).
• Secondary outcomes: changes in quality of life, psychological distress, and healthcare resource use.
• Analysis includes per-protocol assessment for robustness.

Conclusions:

• The study aims to provide evidence on OWise effectiveness for early-stage breast cancer patient activation.
• Results will inform patient-level and NHS health system-level impacts of the OWise app.
• Findings have implications for wider NHS adoption and potential expansion to other cancer types.