Pilot study to determine the utility of a Likert-type scale to assess patients* experience of radiation dermatitis during radiotherapy for breast cancer.
Completed
- Conditions
- Radiation dermatitisradiation induced skin reaction1002211910006291
- Registration Number
- NL-OMON36464
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Female patients undergoing external beam radiotherapy for breast cancer.
Total prescribed dose 40 Gy or more
Irradiation of one or more of the following target areas: breast, chest wall, regional lymph nodes.
Patient can apply creams
Patient able to understand and complete the questionnaire.
patiente is willing to sign informed consent
Exclusion Criteria
Postoperative wound infection within treatment area;
Ulceration or open wound in treatment area;
History of skin diseases in the irradiated area;
Any clinical significant medical condition that could interfere with the conduct of the study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Development of a tool to document patients* experience of the severity and<br /><br>duration of skin reactions after radiotherapy, using a Likert-type scoring<br /><br>system.<br /><br>2. Determination of inter-patient variation, as a pilot to calculate the<br /><br>number of patients required for a comparative clinical study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To assess if the Lickert-type score documented by the patient is comparable<br /><br>to the severity of the side effects evaluated by the investigator at the end of<br /><br>radiation therapy.<br /><br>2. To assess any relationship to patient or treatment related factors to the<br /><br>recorded parameters of patient symptoms.<br /><br>3. To obtain feedback from patients regarding the utility of topical<br /><br>symptomatic treatment of their radiation dermatitis</p><br>