- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803516
QOL Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser
Quality of Life Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser
The purpose of this study is to see how the look of telangiectasias (small dilated blood vessels) on radiated breast skin when altered by the pulsed dye laser affects a patient's overall well being.
Patients will have a set of treatments with a pulsed dye laser. This is a laser that targets red blood vessels and delivers heat causing the telangiectasias to become smaller and less visible. The laser has been used safely to treat telangiectasias on the skin of patients who received radiation for breast cancer.
Patients in the study will be asked to complete a questionnaire asking how they feel about the telangiectasias, their radiated skin and its effect on their daily lives. The questionnaire will be given at every visit. The improvement in the look of patients' radiated skin will also be compared to answers to the questionnaire. We hope the study will improve our understanding of how patients feel about the long term effects of radiation on their skin.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Locally advanced breast cancer patients treated with surgery and adjuvant radiation
- Telangiectasias in the radiation field of the treated breast
- Patients 18 years or older
Exclusion Criteria:
- Non English speaking
- Current oral steroid use or receiving daily therapeutic anticoagulation (e.g. Coumadin, Lovenox)
- Breast/s reconstructed with implant in the area of previous radiation
- Pregnancy or lactation
- Previous laser treatment of telangiectasias
- Presence of a sun tan in the area
- Fitzpatrick skin types V, VI
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Breast cancer survivors with radiation-induced Telangiectasias
A quality of life assessment will also be completed by the patient using the Skindex-16 and a subscale of the BREAST-Q Breast Conserving Module questionnaire.
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This study will be offered to patients who, at the time of consultation are identified as having had adjuvant breast radiation treatment following surgical treatment for breast cancer and developed radiation-induced telangiectasias.
The Skindex-16 and BREAST-Q questionnaires will be used to evaluate the quality of life of The study participants.
For each instrument, for each evaluation time point, QOL scores will be summed and transformed into a scale from 0-100.
Descriptive statistics will be used to describe the QOL of the study participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate quality-of-life (QoL)
Time Frame: 2 years
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in breast cancer survivors with chronic radiation-induced telangiectasias who are undergoing pulsed dye laser treatment.
To assess quality of life in relation to the radiation-induced telangiectasias, two pre-existing validated scales will be utilized.
The Skindex-16 and BREAST-Q are scales that have been validated to assess quality of life.
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2 years
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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