Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Endometrial Cancer Clinical Trial

— SISTER  

Official title:

Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04930159
• Other study ID #: STUDY00012990
• Secondary ID: RG1121627NCI-202
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Recurrence

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