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Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT02912767
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Endometrial Cancer Lymphedema Behavioral: questionnaire

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Study Type : Observational
Actual Enrollment : 625 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer
Study Start Date : July 20, 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Group/Cohort Intervention/treatment
SLN cohort
Patients who underwent hysterectomy only or with SLN mapping alone.
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.

LND cohort
Patients who underwent hysterectomy with standard lymphadenectomy, with or without SLN mapping.
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.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912767


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Mario Leitao, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02912767     History of Changes
Other Study ID Numbers: 16-1001
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
lower-extremity lymphedema
16-1001

Additional relevant MeSH terms:
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Endometrial Neoplasms
Lymphedema
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Lymphatic Diseases