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

NCT ID: NCT00944944

Last Updated: 2010-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-01-31

Brief Summary

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.

Conditions

Ovarian Cancer; Uterine Cancer; Vaginal Cancer; Lymphedema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Gyn Pts with lymphedema

GCLQ lymphedema symptom assessment questionnaire

Intervention Type: BEHAVIORAL

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

limb volume measurements and GCLQ lymphedema symptom assessment questionnaire

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention 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.

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Memorial Sloan-Kettering Cancer Center

Principal Investigators

Richard Barakat, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan-Kettering Cancer Center

Other Identifiers

09-077

Identifier Type: -

Identifier Source: org_study_id