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

Overview

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.

Full Title of Study: “A Pilot Study Using the Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2010

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Gyn Pts with lymphedema
  • Gyn Pts without Lymphedema

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Richard Barakat, MD, Memorial Sloan-Kettering Cancer Center
  • Overall Official(s)
    • Richard Barakat, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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