Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer
1 other identifier
observational
625
1 country
1
Brief Summary
The investigators are interested in understanding how the patient has been doing since their surgery for endometrial cancer and if they are experiencing any symptoms related to lymphedema (swelling) in the your lower body. The investigators hope that information from the patient and others will help them improve care for women treated for endometrial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2016
CompletedFirst Submitted
Initial submission to the registry
September 21, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 4, 2020
June 1, 2020
3.9 years
September 21, 2016
June 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
compare lymphedema prevalence
Data from respondents will be analyzed to determine prevalence of patient reported lymphedema overall; these will then be compared to the prevalence among those who underwent SLN mapping alone, or a comprehensive pelvic lymphadenectomy (+/- para-aortic LND and +/-SLN mapping in conjunction).
1 year
Study Arms (2)
SLN cohort
Patients who underwent hysterectomy only or with SLN mapping alone.
LND cohort
Patients who underwent hysterectomy with standard lymphadenectomy, with or without SLN mapping.
Interventions
A questionnaire that has been validated by investigators at the Mayo Clinic. The questionnaire has 13 items to assess the rate of patient-reported lymphedema. The questionnaire will be mailed and then followed up with a second mailing after month 1 and a phone call after month 2. Within 3 months of sending the questionnaire a patient will be either considered as a responder vs non-responder. The date of surgery and the date of when the questionnaire is filled out will be captured.
Eligibility Criteria
Patients will be identified from a retrospective database maintained by the GYN DMT. Patients will be contacted by mail for the first attempt at recruitment.
You may qualify if:
- Presented to MSK with newly diagnosed endometrial carcinoma of any histologic profile clinically confined to the uterus and/or uterine cervix
- Underwent primary surgery at our institution, to include at least a total hysterectomy via laparotomy, laparoscopy, or robotic approach, between January 2006 and December 2013
- Alive at the time of study activation
You may not qualify if:
- Had documented macroscopic evidence of extrauterine disease at the time of initial diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Leitao, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2016
First Posted
September 23, 2016
Study Start
July 20, 2016
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
June 4, 2020
Record last verified: 2020-06