Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema

January 29, 2010 updated by: Memorial Sloan Kettering Cancer Center

A Pilot Study Using the Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema

The purpose of this study is to evaluate if the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) truly detects symptoms or signs of lower extremity lymphedema in patients with diagnosed lower extremity lymphedema. Lymphedema is a chronic condition in which fluid accumulates in the tissues of the body. Many cancer survivors are living with discomfort and changes in their activities due to limb swelling following cancer treatment. If the GCLQ is able to do detect signs and symptoms of lymphedema, the investigators hope to use it as a tool in the clinical care setting to help identify women at risk for or with lymphedema. In the future, this could improve clinical care through the use of a more simple and feasible way to identify lower extremity lymphedema than measuring limbs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

58

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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Potential GYN research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).

Description

Inclusion Criteria:

  • Study group of Gynecologic cancer survivors with Lymphedema
  • Documented lower extremity lymphedema
  • History of a primary diagnosis of gynecologic cancer (vulvar, cervical and uterine only)
  • History of surgery for gynecologic cancer including lymph node removal
  • No evidence of disease or active treatment
  • At least 21 years of age
  • Able and willing to provide informed consent
  • English fluency Comparison Group of Gynecologic Cancer Survivors without Lymphedema
  • No history of lower extremity lymphedema or presence of lymphedema confirmed by limb volume measurements at the time of study participation
  • History of a primary diagnosis of gynecologic cancer (vulvar, cervical and uterine only)
  • History of surgery for gynecologic cancer including lymph node removal
  • No evidence of disease or active treatment
  • At least 21 years of age
  • Able and willing to provide informed consent
  • English fluency

Exclusion Criteria:

  • Inability to participate in an informed consent process
  • Patients with a psychiatric disorder precluding response to the survey

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
Gyn Pts with lymphedema
Behavioral: GCLQ lymphedema symptom assessment questionnaire
The gynecologic cancer survivors with lymphedema group will have documented lower extremity lymphedema. Participants will be asked to complete a one time assessment, the Gynecologic Cancer Lymphedema Questionnaire to identify lower extremity lymphedema symptoms in gynecologic cancer survivors. They will also be asked to provide feedback about their satisfaction with and the feasibility of the GCLQ as a brief assessment tool that could be used in the clinical care setting.
Gyn Pts without Lymphedema
Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire
Upon obtaining consent, the participants without a history of lower extremity lymphedema will be asked to undergo limb volume measurements to ensure the accuracy of group assignment to the nonlymphedema group. Participants will then be asked to complete the one time GCLQ lymphedema symptom assessment questionnaire. The survey tool and Limb volume (LV) data and feedback from participants about the GCLQ will be collected. We expect the study survey to take approximately 5-10 minutes to complete and 5-10 minutes to collect LV data.
Other Names:
  • After completion of the GCLQ lower extremity lymphedema assessment tool, participants will be asked
  • to provide feedback about their satisfaction with and the feasibility of using this brief assessment tool!
  • screening mechanism to identify lymphedema symptoms in the clinical care setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if the Gynecologic Cancer Lymphedema Questionnaire (GCLQ)tools detects lower extremity lymphedema symptoms in gynecologic cancer survivors & if it is a feasible assessment tool which can be used in the clinical care setting.
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Richard Barakat, MD, 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

July 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (ESTIMATE)

July 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2010

Last Update Submitted That Met QC Criteria

January 29, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-077

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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