Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Behavioral: Facilitated group support
* Behavioral: 1:1 Peer Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18 years of age or older; and 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 FIGO Stage 1A with Grade 2, Grade 3, or Grade 4 of any histology type or 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: Participants must not have any of the following exclusion criteria: Newly diagnosis of FIGO Stage IA Grade 1 endometrioid 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced usual care<br>Written materials in an appealing package. | |
| Active Comparator: Facilitated group support<br>Weekly group gatherings. | Behavioral: Facilitated group support<br>* 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.<br>|
| Active Comparator: 1:1 Peer Support<br>Individual peer support calls. | Behavioral: 1:1 Peer Support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |