Clinical trial · Interventional
Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
NCT04930159CI-TRIAL-00109642SISTERactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1:1 Peer Support | Behavioral | — | UNRESOLVED |
| Facilitated group support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Enhanced usual care
- description
- Written materials in an appealing package.
- type
- ACTIVE_COMPARATOR
- label
- Facilitated group support
- description
- Weekly group gatherings.
- interventionNames
- Behavioral: Facilitated group support
- type
- ACTIVE_COMPARATOR
- label
- 1:1 Peer Support
- description
- Individual peer support calls.
- interventionNames
- Behavioral: 1:1 Peer Support
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOluloro 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 38348827