Using a reminder app to improve skin care for breast cancer patients during radiation therapy
Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade ≥2 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)
This study tests if a reminder app can help breast cancer patients take better care of their skin during radiation therapy and reduce skin problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 268 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Schleswig-Holstein Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Vejle, Southern Denmark and 4 other locations) |
| Trial ID | NCT06483477 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a reminder app designed to prompt breast cancer patients to perform necessary skin care routines during adjuvant radiotherapy. A total of 268 patients will be randomly assigned to either receive standard skin care with the app or standard skin care alone. The primary goal is to determine if the app can reduce the incidence of grade ≥2 radiation dermatitis. Secondary objectives include assessing pain levels, patient satisfaction with the app, and the app's impact on health technology usage.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with histologically proven invasive breast cancer who are scheduled for adjuvant radiotherapy and can use a smartphone.
Not a fit: Patients who are pregnant, lactating, or expected to be non-compliant with the treatment protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the severity of radiation dermatitis in breast cancer patients undergoing treatment.
How similar studies have performed: While the use of mobile applications in healthcare is growing, this specific approach to managing radiation dermatitis is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically proven invasive breast cancer 2. Indication for adjuvant hypo-fractionated radiotherapy 3. Possession of and ability to use a smartphone 4. Female gender 5. Age ≥18 years 6. Written informed consent 7. Capacity of the patient to contract Exclusion Criteria: 1. Pregnancy, Lactation 2. Expected non-compliance
Where this trial is running
Vejle, Southern Denmark and 4 other locations
- Vejle Hospital, University Hospital of Southern Denmark — Vejle, Southern Denmark, Denmark (Not_yet_recruiting)
- Medical Practice for Radiotherapy and Radiation Oncology — Hanover, Lower Saxony, Germany (Not_yet_recruiting)
- Medical School Hamburg, Schwerin Campus — Schwerin, Mecklenburg-Vorpommern, Germany (Not_yet_recruiting)
- Malteser Hospital St. Franziskus — Flensburg, Schleswig-Holstein, Germany (Not_yet_recruiting)
- Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein — Lübeck, Germany (Recruiting)
Study contacts
- Principal investigator: Dirk Rades, MD, FASTRO — Dept. of Radiation Oncology, University of Lubeck, Germany
- Study coordinator: Dirk Rades, MD, FASTRO
- Email: DIRK.RADES@UKSH.DE
- Phone: 0049-451-500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.