Clinical trial NCT00944944: Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema
Official title: A Pilot Study Using the Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Uterine Cancer
Vaginal Cancer
Lymphedema
Keywords: CORPUS UTERI,
ENDOMETRIUM
FALLOPIAN TUBE
OVARY
VAGINA
Lymphedema
Questionnaire
Quality of Life
09-077
Fallopian Tubes
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 58
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential GYN research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Richard Barakat, MD
role: PRINCIPAL_INVESTIGATOR
References: