Actively Recruiting
Preventing Moderate to Severe Radiation Skin Reactions in Women Receiving Adjuvant Radiotherapy for Breast Cancer Using a Skin Care Reminder App
Led by University Hospital Schleswig-Holstein · Updated on 2025-01-16
268
Participants Needed
5
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether using a reminder app alongside standard skin care helps reduce the occurrence of moderate to severe radiation dermatitis in female breast cancer patients receiving adjuvant radiotherapy. This multinational, randomized trial compares standard skin care alone to standard skin care supported by an app that reminds patients to perform skin care four times daily. The study also looks at pain levels, patient satisfaction with the app, and how the app affects the use of health technology, especially in different age groups. Participants receive radiotherapy over about three to four weeks using hypo-fractionated doses, with some patients receiving additional radiation boosts based on age and risk factors. All patients perform standard skin care, which includes applying fatty cream with urea and possibly mometasone furoate cream in the app-supported group, patients also receive reminders and guidance through the app. The app allows patients to set notification schedules, postpone care reminders, and earn points for adherence. Patients in the app group will complete a questionnaire on their satisfaction and the apps impact at the end of treatment. During the study, radiation dermatitis is assessed weekly and at the end of radiotherapy by trained observers. Pain scores and patient satisfaction are also measured throughout the approximately four-week treatment period. Data on the apps use and support benefits are collected from the app group. The study includes 268 female patients aged 18 years and older with invasive breast cancer, who can use a smartphone and provide consent. Safety and compliance are monitored, with statistical analysis planned to compare outcomes between groups.
CONDITIONS
Brief Title
Dermatitis During Adjuvant Irradiation for BREAst Cancer:
Research Team
D
Dirk Rades, MD, FASTRO
C
Carlos A. Narvaez-Wolf, MD
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