Endometrial Cancer Clinical Trial
— SISTEROfficial title:
Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
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.
Status | Recruiting |
Enrollment | 252 |
Est. completion date | September 30, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult 18 years of age or older; and 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: Participants must not have any of the following exclusion criteria: 1. Newly diagnosis of FIGO Stage IA Grade 1 endometrioid adenocarcinoma 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Alabama | Birmingham | Alabama |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | The University of Chicago | Chicago | Illinois |
United States | MedStar Health Research Institute | Columbia | Maryland |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | University of Miami | Miami | Florida |
United States | Louisiana State University - New Orleans | New Orleans | Louisiana |
United States | Weill Cornell Medicine | New York | New York |
United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Patient-reported social isolation (SPS-24) | The Social Provisions Scale (SPS) is one of the most frequently used scales on social support, and is validated to measure the components of social support that directly impact health outcomes: attachment, social integration, reassurance of worth, reliable alliance, guidance, and opportunity for nurturance. | 6 months |
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