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Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02912767
Enrollment
625
Registered
2016-09-23
Start date
2016-07-20
Completion date
2020-06-01
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, Lymphedema

Keywords

lower-extremity lymphedema, 16-1001

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.

Interventions

BEHAVIORALquestionnaire

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
compare lymphedema prevalence1 yearData 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026