Pilot study to determine the utility of a Likert-type scale to assess patients* experience of radiation dermatitis during radiotherapy for breast cancer.

Pilot study to determine the utility of a Likert-type scale to assess patients* experience of radiation dermatitis during radiotherapy for breast cancer. - N10RDA. Radiation dermatitis assessment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36464

Enrollment

150

Registered

2011-06-23

Start date

2012-01-09

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation dermatitis radiation induced skin reaction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Development of a tool to document patients* experience of the severity and duration of skin reactions after radiotherapy, using a Likert-type scoring system. 2. Determination of inter-patient variation, as a pilot to calculate the number of patients required for a comparative clinical study.	—

Secondary

Measure	Time frame
1. To assess if the Lickert-type score documented by the patient is comparable to the severity of the side effects evaluated by the investigator at the end of radiation therapy. 2. To assess any relationship to patient or treatment related factors to the recorded parameters of patient symptoms. 3. To obtain feedback from patients regarding the utility of topical symptomatic treatment of their radiation dermatitis	—

Measure

Time frame

1. To assess if the Lickert-type score documented by the patient is comparable to the severity of the side effects evaluated by the investigator at the end of radiation therapy. 2. To assess any relationship to patient or treatment related factors to the recorded parameters of patient symptoms. 3. To obtain feedback from patients regarding the utility of topical symptomatic treatment of their radiation dermatitis

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Countries

Netherlands

Outcome results