Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (NCT04930159) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
United States252 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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);