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

Completed

• Conditions: Ovarian Cancer; Uterine Cancer; Vaginal Cancer; Lymphedema
• Interventions: Behavioral: GCLQ lymphedema symptom assessment questionnaire; Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire

• Registration Number: NCT00944944
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-29
• Last Update Posted: 2010-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gyn Pts with lymphedema	GCLQ lymphedema symptom assessment questionnaire	-
Gyn Pts without Lymphedema	limb volume measurements and GCLQ lymphedema symptom assessment questionnaire	-

Primary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States