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

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ClinicalTrials.gov Identifier: NCT00944944
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : February 1, 2010
Sponsor:
Information provided by:
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date July 22, 2009
First Posted Date July 23, 2009
Last Update Posted Date February 1, 2010
Study Start Date July 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Ovarian Cancer
  • Uterine Cancer
  • Vaginal Cancer
  • Lymphedema
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • Gyn Pts with lymphedema
    Intervention: Behavioral: GCLQ lymphedema symptom assessment questionnaire
  • Gyn Pts without Lymphedema
    Intervention: Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 21, 2009)
58
Original Estimated Enrollment
 (submitted: July 22, 2009)
50
Actual Study Completion Date January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00944944
Other Study ID Numbers 09-077
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Richard Barakat, MD, Memorial Sloan-Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Richard Barakat, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2010