Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

Completed

• Conditions: Endometrial Cancer; Lymphedema
• Interventions: Behavioral: questionnaire

• Registration Number: NCT02912767
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-20
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Status Verified: 2020-06
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 625

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SLN cohort	questionnaire	Patients who underwent hysterectomy only or with SLN mapping alone.
LND cohort	questionnaire	Patients who underwent hysterectomy with standard lymphadenectomy, with or without SLN mapping.

Primary Outcome Measures

Name	Time	Method
compare lymphedema prevalence	1 year	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).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States