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

NCT01803516 | Completed

• 1 other identifier: 13-013
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Radiation-Induced Telangiectasias

Keywords

Quality of Life; Assessments; Radiation; Telangiectasias; 13-013

Outcome Measures

Primary Outcomes (1)

• evaluate quality-of-life (QoL)

  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

Study Arms (1)

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

Interventions

questionnaires BEHAVIORAL

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.

Breast cancer survivors with radiation-induced Telangiectasias

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Telangiectasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Erica Lee, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 4, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

US (1)