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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01803516
First received: February 28, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 before the first laser treatment and after the final treatment. 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 Intervention
Breast Cancer
Radiation-Induced Telangiectasias
Behavioral: questionnaires

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • evaluate quality-of-life (QoL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast cancer survivors with radiation-induced Telangiectasias
A pre-treatment and post-treatment 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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) (Rockefeller Outpatient Pavilion on 53rd street) 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.

Criteria

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)
  • Pregnancy or lactation
  • Previous laser treatment of telangiectasias
  • Presence of a sun tan in the area
  • Fitzpatrick skin types V, VI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803516

Contacts
Contact: Erica Lee, MD 212-610-0724
Contact: Kishwer Nehal, MD 212-610-0782

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Erica Lee, MD    212-610-0724      
Contact: Kishwer Nehal, MD    212-610-0782      
Principal Investigator: Erica Lee, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Erica Lee, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01803516     History of Changes
Other Study ID Numbers: 13-013
Study First Received: February 28, 2013
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of Life
Assessments
Radiation
Telangiectasias
13-013

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

ClinicalTrials.gov processed this record on July 26, 2014