Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema - Full Text View

Purpose

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.

Condition	Intervention
Ovarian Cancer Uterine Cancer Vaginal Cancer Lymphedema	Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire Behavioral: GCLQ lymphedema symptom assessment questionnaire

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Pilot Study Using the Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema

Resource links provided by NLM:

Genetics Home Reference related topics: lymphedema-distichiasis syndrome

MedlinePlus related topics: Cancer Lymphedema Ovarian Cancer Uterine Cancer Vaginal Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	July 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Gyn Pts with lymphedema	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.
Gyn Pts without Lymphedema	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. 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.

Groups/Cohorts

Assigned Interventions

Gyn Pts with lymphedema

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.

Gyn Pts without Lymphedema

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.

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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).

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944944

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Richard Barakat, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Richard Barakat, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00944944 History of Changes
Other Study ID Numbers:	09-077
Study First Received:	July 22, 2009
Last Updated:	January 29, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

CORPUS UTERI,
ENDOMETRIUM
FALLOPIAN TUBE
OVARY
VAGINA

Lymphedema
Questionnaire
Quality of Life
09-077
Fallopian Tubes

Additional relevant MeSH terms:

Lymphedema
Ovarian Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Lymphatic Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases

Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases
Vaginal Diseases

ClinicalTrials.gov processed this record on June 17, 2013