Ovarian CancerNCT00944944
Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema
An observational study of Ovarian Cancer and Uterine Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Uterine Cancer, Vaginal Cancer
- What is being tested?
- limb volume measurements and GCLQ lymphedema symptom assessment questionnaire and GCLQ lymphedema symptom assessment questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Inability to participate in an informed consent process
- Patients with a psychiatric disorder precluding response to the survey
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Ovarian Cancer, Uterine Cancer, Vaginal Cancer, Lymphedema
- Being tested
- limb volume measurements and GCLQ lymphedema symptom assessment questionnaire, GCLQ lymphedema symptom assessment questionnaire
- Keywords
- CORPUS UTERI,, ENDOMETRIUM, FALLOPIAN TUBE, OVARY, VAGINA, Lymphedema, Questionnaire, Quality of Life, 09-077, Fallopian Tubes
- Medical subject headings
- Ovarian Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limb volume measurements and GCLQ lymphedema symptom assessment questionnaireBehavioural
Also called 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.
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.
GCLQ lymphedema symptom assessment questionnaireBehavioural
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 group | Role | What they receive |
|---|---|---|
| Gyn Pts with lymphedema | Not described Receives: Behavioral: GCLQ lymphedema symptom assessment questionnaire | |
| Gyn Pts without Lymphedema | Not described Receives: Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Richard Barakat, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944944
- Sponsor's protocol ID
- 09-077
- Status last verified
- Jan 2010
- First submitted
- 22 Jul 2009
- Last updated
- 1 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using the Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT00944944
- Acronym / sponsor ID
- 09-077
- Conditions
- Ovarian Cancer, Uterine Cancer, Vaginal Cancer, Lymphedema
- Keywords
- CORPUS UTERI,, ENDOMETRIUM, FALLOPIAN TUBE, OVARY, VAGINA, Lymphedema, Questionnaire, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gyn Pts with lymphedema | – | Behavioral: GCLQ lymphedema symptom assessment questionnaire |
| Gyn Pts without Lymphedema | – | Behavioral: limb volume measurements and GCLQ lymphedema symptom assessment questionnaire |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to participate in an informed consent process
- Patients with a psychiatric disorder precluding response to the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| limb volume measurements and GCLQ lymphedema symptom assessment questionnaireAlso: 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.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. | Behavioural | Gyn Pts without Lymphedema |
| GCLQ lymphedema symptom assessment questionnaireThe 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. | Behavioural | Gyn Pts with lymphedema |
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.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2010.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Barakat, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Uterine Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2010.