Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult 18 years of age or older; and

• Self-identify as Black/African American

• Presenting with high-risk EC established by anatomic pathology as tumor stage and grade classification by the following:

‣ Pathology documentation from any hospital/clinic/medical center, and

⁃ FIGO Stage 1A with Grade 2, Grade 3, or Grade 4 of any histology type or

⁃ FIGO Stage 1A with non-endometrioid (carcinosarcoma, serous, clear cell, undifferentiated or mixed) histology

⁃ FIGO Stage 1B, 2, 3, or 4 of any grade or histology

⁃ Recurrent endometrial cancer of any stage or grade

• Documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy.

Locations
United States
Alabama
University of Alabama
RECRUITING
Birmingham
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Florida
University of Miami
RECRUITING
Miami
Illinois
The University of Chicago
RECRUITING
Chicago
Louisiana
Louisiana State University - New Orleans
RECRUITING
New Orleans
Maryland
Johns Hopkins University
RECRUITING
Baltimore
MedStar Health Research Institute
RECRUITING
Columbia
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New York
Weill Cornell Medicine
RECRUITING
New York
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Contact Information
Primary
Kemi M Doll, MD, MS
kdoll@uw.edu
206-543-3669
Backup
SISTER team
sisterstudy@uw.edu
1-844-374-7837
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 252
Treatments
No_intervention: Enhanced usual care
Written materials in an appealing package.
Active_comparator: Facilitated group support
Weekly group gatherings.
Active_comparator: 1:1 Peer Support
Individual peer support calls.
Related Therapeutic Areas
Sponsors
Leads: University of Washington
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov