Breast CancerNCT01803516
QOL Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser
An observational study of Breast Cancer and Radiation-Induced Telangiectasias, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Radiation-Induced Telangiectasias
- What is being tested?
- questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Breast Cancer, Radiation-Induced Telangiectasias
- Being tested
- questionnaires
- Keywords
- Quality of Life, Assessments, Radiation, Telangiectasias, 13-013
- Medical subject headings
- Breast Neoplasms, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803516
- Sponsor's protocol ID
- 13-013
- Status last verified
- Feb 2018
- First submitted
- 28 Feb 2013
- Last updated
- 7 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser
- ClinicalTrials.gov ID
- NCT01803516
- Acronym / sponsor ID
- 13-013
- Conditions
- Breast Cancer, Radiation-Induced Telangiectasias
- Keywords
- Quality of Life, Assessments, Radiation, Telangiectasias, 13-013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors with radiation-induced Telangiectasias | – | Behavioral: questionnairesA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesThis 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. | Behavioural | Breast cancer survivors with radiation-induced Telangiectasias |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Lee, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiation-Induced Telangiectasias, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate quality-of-life (QoL) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.