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

January 29, 2010 updated by: Memorial Sloan Kettering Cancer Center

A Pilot Study Using the Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Barakat, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphedema

Clinical Trials on GCLQ lymphedema symptom assessment questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings