Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
NCT ID: NCT04930159
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
252 participants
INTERVENTIONAL
2021-09-01
2030-10-31
Brief Summary
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Detailed Description
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The SISTER study comparators are based on multiple systematic reviews of peer support literature, input from the multi-stakeholder Steering Group of the Endometrial Cancer Action Network for African Americans (ECANA), two focus groups of Black women with EC, and cancer center leadership at selected enrollment sites. The core function of each comparator is to decrease social isolation for women on active treatment. Of the peer support intervention options available, the SISTER study includes the two that have the most data collected among Black women with cancer, have been most efficacious with regard to social isolation9 and treatment completion, and were enthusiastically supported by ECANA patient partners and focus group data.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Enhanced usual care
Written materials in an appealing package.
No interventions assigned to this group
Facilitated group support
Weekly group gatherings.
Facilitated group support
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
Individual peer support calls.
1:1 Peer Support
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.
Interventions
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Facilitated group support
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
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
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Inclusion Criteria
2. Self-identify as Black/African American
3. Presenting with high-risk EC established by anatomic pathology as tumor stage and grade classification by the following:
1. Pathology documentation from any hospital/clinic/medical center, and
2. FIGO Stage 1A with Grade 2, Grade 3, or Grade 4 of any histology type or
3. FIGO Stage 1A with non-endometrioid (carcinosarcoma, serous, clear cell, undifferentiated or mixed) histology
4. FIGO Stage 1B, 2, 3, or 4 of any grade or histology
5. Recurrent endometrial cancer of any stage or grade
4. Documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy.
Exclusion Criteria
2. Previous history of other cancer diagnosis requiring chemotherapy, radiation therapy, or immunotherapy within the past 12 months;
3. Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
4. Contraindication to all non-surgical therapy available for endometrial cancer (i.e., chemotherapy, radiation, and immunotherapy contraindicated);
5. Enrollment into hospice prior to randomization
6. Unable to provide written informed consent in English;
7. Unable to be contacted for research surveys;
8. Recent hospitalization for psychiatric illness in the past 6 months
18 Years
FEMALE
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Washington
OTHER
Responsible Party
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Kemi Doll
Assistant Professor, School of Medicine
Principal Investigators
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Kemi M Doll, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Alabama
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Miami
Miami, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Louisiana State University - New Orleans
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
MedStar Health Research Institute
Columbia, Maryland, United States
Weill Cornell Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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RG1121627
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2021-12773
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00012990
Identifier Type: -
Identifier Source: org_study_id