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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cancer, Uterine Cancer, Vaginal Cancer, Lymphedema

Intervention / Treatment
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* Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire
* Behavioral: GCLQ lymphedema symptom assessment questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gyn Pts with lymphedema<br> | Behavioral: GCLQ lymphedema symptom assessment questionnaire<br>* 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.<br>|
| Gyn Pts without Lymphedema<br> | Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire<br>* 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.<br>* Other names: screening mechanism to identify lymphedema symptoms in the clinical care setting.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CORPUS UTERI,, ENDOMETRIUM, FALLOPIAN TUBE, OVARY, VAGINA, Lymphedema, Questionnaire, Quality of Life, 09-077, Fallopian Tubes