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

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Brief Title

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

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.
    



Study Type

Observational


Primary Outcome

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.


Condition

Ovarian Cancer

Intervention

limb volume measurements and GCLQ lymphedema symptom assessment questionnaire

Study Arms / Comparison Groups

 Gyn Pts with lymphedema
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

58

Start Date

July 2009

Completion Date

January 2010

Primary Completion Date

January 2010

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
      

Gender

Female

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Richard Barakat, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00944944

Organization ID

09-077



Study Sponsor

Memorial Sloan Kettering Cancer Center


Study Sponsor

Richard Barakat, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

January 2010