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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01803516
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment
Breast Cancer Radiation-Induced Telangiectasias Behavioral: questionnaires

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser
Study Start Date : February 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01803516

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Principal Investigator: Erica Lee, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT01803516     History of Changes
Other Study ID Numbers: 13-013
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Vascular Diseases
Cardiovascular Diseases