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

NCT00944944 | Completed

• 1 other identifier: 09-077
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gyn Pts with lymphedema

Behavioral: GCLQ lymphedema symptom assessment questionnaire

Gyn Pts without Lymphedema

Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire

Interventions

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.

Also known as: 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.

Gyn Pts without Lymphedema

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.

Gyn Pts with lymphedema

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Inability to participate in an informed consent process
• Patients with a psychiatric disorder precluding response to the survey

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Neoplasms; Vaginal Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Barakat, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 1, 2010

Record last verified: 2010-01

Locations

US (1)