Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade ≥2 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In the randomized DAI-BREAC trial, a reminder app will be prospectively tested that reminds breast cancer patients four times each day to perform the required skin care. This will likely contribute to the reduction of grade ≥2 radiation dermatitis in these patients. A total of 268 patients will be randomized to receive standard skin care supported by a reminder app (Arm A) or standard skin care alone (Arm B). Stratification will be done using the three factors treatment volume, radiation boost, and at least one risk factor of dermatitis. Secondary aims include pain (radiation fields), patient satisfaction with the reminder app (Arm A only), impact of the app on the use of health technology (Arm A only), and benefit from support by staff members of the treating Department of Radiation Oncology and/or the UKSH academy regarding the use of the app (Arm A only).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically proven invasive breast cancer

• Indication for adjuvant hypo-fractionated radiotherapy

• Possession of and ability to use a smartphone

• Female gender

• Age ≥18 years

• Written informed consent

• Capacity of the patient to contract

Locations
Other Locations
Denmark
Vejle Hospital, University Hospital of Southern Denmark
NOT_YET_RECRUITING
Vejle
Germany
Malteser Hospital St. Franziskus
NOT_YET_RECRUITING
Flensburg
Medical Practice for Radiotherapy and Radiation Oncology
NOT_YET_RECRUITING
Hanover
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
RECRUITING
Lübeck
Medical School Hamburg, Schwerin Campus
NOT_YET_RECRUITING
Schwerin
Contact Information
Primary
Dirk Rades, MD, FASTRO
DIRK.RADES@UKSH.DE
0049-451-500
Backup
Carlos A. Narvaez-Wolf, MD
Carlos.Narvaez-Wolf@uksh.de
0049-451-500
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 268
Treatments
Experimental: Arm A
Standard skin care supported by a reminder app
Active_comparator: Arm B
Standard skin care alone
Related Therapeutic Areas
Sponsors
Collaborators: Medical School Hamburg, University of Southern Denmark
Leads: University Hospital Schleswig-Holstein

This content was sourced from clinicaltrials.gov