Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

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.

Primary outcomes

compare lymphedema prevalence

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Sep 23, 2016
Registry last updated: Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed