Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
SISTER
3 other identifiers
interventional
252
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
ExpectedApril 28, 2026
April 1, 2026
4.6 years
June 11, 2021
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment completion (relative dose)
Relative dose is the ratio of actual-to-expected total dose of treatment received. The calculation of expected total dose will be made from the baseline treatment recommendation data collected at enrollment.
6 months
Secondary Outcomes (1)
Patient-reported social isolation (SPS-24)
6 months
Study Arms (3)
Enhanced usual care
NO INTERVENTIONWritten materials in an appealing package.
Facilitated group support
ACTIVE COMPARATORWeekly group gatherings.
1:1 Peer Support
ACTIVE COMPARATORIndividual peer support calls.
Interventions
Weekly group gatherings where content will alternate between group conversation and focused topics (e.g., treatment side-effects, mental health, family dynamics, nutrition, financial hardship) with facilitated discussion by a trained professional in nutrition, psychotherapy, cognitive behavioral therapy, or medicine. Each group will cycle through the same order of topics.
1:1 peer support via telephone or video either during or near a treatment visit. Call content will be focused on social support and driven by the needs of the participant.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Newly diagnosis of FIGO Stage IA Grade 1 endometrioid adenocarcinoma
- Previous history of other cancer diagnosis requiring chemotherapy, radiation therapy, or immunotherapy within the past 12 months;
- Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
- Contraindication to all non-surgical therapy available for endometrial cancer (i.e., chemotherapy, radiation, and immunotherapy contraindicated);
- Enrollment into hospice prior to randomization
- Unable to provide written informed consent in English;
- Unable to be contacted for research surveys;
- Recent hospitalization for psychiatric illness in the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
Related Publications (1)
Oluloro A, Comstock B, Monsell SE, Gross M, Wolff EM, Sage L, Alson J, Lavallee DC, Hempstead B, Moore A, Katz R, Doll KM. Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial. J Comp Eff Res. 2024 Mar;13(3):e230159. doi: 10.57264/cer-2023-0159. Epub 2024 Feb 13.
PMID: 38348827DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kemi M Doll, MD, MS
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, School of Medicine
Study Record Dates
First Submitted
June 11, 2021
First Posted
June 18, 2021
Study Start
September 1, 2021
Primary Completion
April 7, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The time frame is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board
- Access Criteria
- The access criteria is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board
Only de-identified data will be shared with other researchers. Researchers will be required to receive approval from the SISTER Advocate Advisory Board to receive data.