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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

limb volume measurements and GCLQ lymphedema symptom assessment questionnaire

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.

Other 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.

GCLQ lymphedema symptom assessment questionnaire

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 23, 2009
Registry last updated: Feb 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed