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NCT02912767 Clinical Trial

Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:
Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02912767
Other study ID # 16-1001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 20, 2016
Est. completion date June 1, 2020

Study information
Verified date June 2020
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 625
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Had documented macroscopic evidence of extrauterine disease at the time of initial diagnosis

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• questionnaire
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.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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