QOL Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser

February 5, 2018 updated by: Memorial Sloan Kettering Cancer Center

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the Dermatology Division and/or Radiation Oncology, Plastic and Reconstructive Surgery Department(s) and the Breast Cancer Survivorship Program will be identified by the Nurse Practitioners of the survivorship program or by clinicians in these departments for the study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: questionnaires
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate quality-of-life (QoL)
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (ESTIMATE)

March 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

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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