Social support interventions for Black patients with endometrial cancer

Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

This study tests different types of social support for Black patients with high-risk endometrial cancer to see if it helps them finish their treatment and feel less isolated.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Washington (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 11 sites (Birmingham, Alabama and 10 other locations)
• Trial ID: NCT04930159 on ClinicalTrials.gov

What this trial studies

The SISTER study is a randomized trial designed to evaluate different social support modalities for Black patients undergoing treatment for high-risk endometrial cancer. Participants will be assigned to one of three groups: enhanced usual care, weekly group support, or 1:1 peer support. The primary goal is to assess treatment completion rates, while the secondary goal focuses on reducing social isolation among participants. This study is informed by systematic reviews and input from stakeholders, ensuring that the interventions are tailored to the needs of the community.

Who should consider this trial

Good fit: Ideal candidates for this study are Black/African American adults aged 18 and older with high-risk endometrial cancer who are about to begin adjuvant therapy.

Not a fit: Patients with newly diagnosed FIGO Stage IA Grade 1 endometrioid adenocarcinoma or those with a history of other cancers requiring similar treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment completion rates and reduce feelings of social isolation among Black patients with endometrial cancer.

How similar studies have performed: Previous studies have shown success with peer support interventions in cancer care, particularly among Black women, indicating that this approach is both relevant and potentially effective.

Eligibility criteria

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

Where this trial is running

Birmingham, Alabama and 10 other locations

• University of Alabama — Birmingham, Alabama, United States (Recruiting)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
• University of Miami — Miami, Florida, United States (Recruiting)
• The University of Chicago — Chicago, Illinois, United States (Recruiting)
• Louisiana State University - New Orleans — New Orleans, Louisiana, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• MedStar Health Research Institute — Columbia, Maryland, United States (Recruiting)
• Weill Cornell Medicine — New York, New York, United States (Recruiting)
• University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Kemi M Doll, MD, MS — University of Washington
• Study coordinator: Kemi M Doll, MD, MS

Conditions Endometrial Cancer