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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944944
• Other study ID #: 09-077
• Status: Completed
• Phase: N/A
• First received: July 22, 2009
• Last updated: January 29, 2010
• Start date: July 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphedema
• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center