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Social Interventions for Support During Treatment for Patients with Endometrial Cancer, SISTER Study
Trial Status: active
This clinical trial studies whether enhanced usual care, weekly support groups led by peer supporters, or 1-on-1 peer support check-ins work better to support Black patients with endometrial cancer during treatment. Social interventions, such as enhanced usual care, weekly support groups led by peer supporters, or 1-on-1 peer support check-ins during treatment, may provide support and improve the well-being and quality of life of patients with endometrial cancer.
Inclusion Criteria
Adult 18 years of age or older
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
* International Federation of Gynecologists & Obstetricians (FIGO) stage 1A with grade 2, grade 3, or grade 4 of any histology type
* 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
Documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy
Exclusion Criteria
Newly diagnosis of FIGO stage IA grade 1 endometroid 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)
Enrollment into hospice prior to randomization
Unable to provide written informed consent in English
Unable to be contacted for research surveys
Recent hospitalization for psychiatric illness in the past 6 months
Additional locations may be listed on ClinicalTrials.gov for NCT04930159.
I. To determine whether -- and to what extent -- 2 virtual evidenced-based interventions – (1) facilitated support group and (2) 1:1 peer support compared to receipt of usual care improve recommended treatment completion among Black people with high-risk endometrial cancer (EC).
II. To compare the effectiveness of virtual evidenced-based interventions on level of social isolation during cancer treatment among Black people with high-risk EC.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients undergo enhanced usual care.
GROUP II: Patients participate in a weekly support group.
GROUP III: Patients participate in 1-on-1 peer support.
After randomization, patients are followed up at 1, 3, and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
