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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04930159
Other study ID # STUDY00012990
Secondary ID RG1121627NCI-202
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date September 30, 2025

Study information

Verified date April 2024
Source University of Washington
Contact Kemi M Doll, MD, MS
Phone 206-543-3669
Email kdoll@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

SISTER is a prospective, open randomized controlled trial of U.S. Black/African-American people with high-risk endometrial cancer requiring treatment with chemotherapy, radiation, or immunotherapy. We will compare social support interventions of enhanced usual care, weekly group-based support, and 1:1 peer support to determine the most effective option to improve treatment completion and decrease social isolation. The SISTER study comparators are based on multiple systematic reviews of peer support literature, input from the multi-stakeholder Steering Group of the Endometrial Cancer Action Network for African Americans (ECANA), two focus groups of Black women with EC, and cancer center leadership at selected enrollment sites. The core function of each comparator is to decrease social isolation for women on active treatment. Of the peer support intervention options available, the SISTER study includes the two that have the most data collected among Black women with cancer, have been most efficacious with regard to social isolation9 and treatment completion, and were enthusiastically supported by ECANA patient partners and focus group data.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Facilitated group support
Weekly group gatherings where content will alternate between group conversation and focused topics (e.g., treatment side-effects, mental health, family dynamics, nutrition, financial hardship) with facilitated discussion by a trained professional in nutrition, psychotherapy, cognitive behavioral therapy, or medicine. Each group will cycle through the same order of topics.
1:1 Peer Support
1:1 peer support via telephone or video either during or near a treatment visit. Call content will be focused on social support and driven by the needs of the participant.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Washington Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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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