ACTIVE_NOT_RECRUITING

Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

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Conditions

Endometrial Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The SISTER study is a randomized trial, looking at various modalities of social support for Black patients undergoing treatment for endometrial cancer. There are three study arms: group support, 1:1 peer support, and enhanced usual care. The primary outcome is treatment completion, and the secondary outcome is social isolation.

Official Title

Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Quick Facts

Study Start:2021-09-01
Study Completion:2030-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04930159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult 18 years of age or older; and
  2. 2. Self-identify as Black/African American
  3. 3. Presenting with high-risk EC established by anatomic pathology as tumor stage and grade classification by the following:
  4. 1. Pathology documentation from any hospital/clinic/medical center, and
  5. 2. FIGO Stage 1A with Grade 2, Grade 3, or Grade 4 of any histology type or
  6. 3. FIGO Stage 1A with non-endometrioid (carcinosarcoma, serous, clear cell, undifferentiated or mixed) histology
  7. 4. FIGO Stage 1B, 2, 3, or 4 of any grade or histology
  8. 5. Recurrent endometrial cancer of any stage or grade
  9. 4. Documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Kemi M Doll, MD, MS
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35294
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
University of Miami
Miami, Florida, 33136
United States
The University of Chicago
Chicago, Illinois, 60637
United States
Louisiana State University - New Orleans
New Orleans, Louisiana, 70112
United States
Johns Hopkins University
Baltimore, Maryland, 21218
United States
MedStar Health Research Institute
Columbia, Maryland, 21044
United States
Weill Cornell Medicine
New York, New York, 10021
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Kemi M Doll, MD, MS, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01
Study Completion Date2030-10-31

Study Record Updates

Study Start Date2021-09-01
Study Completion Date2030-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Endometrial Cancer