Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER)

University of Washington

Status: Active, not recruiting

Conditions: Endometrial Cancer

Treatments: Behavioral: Facilitated group support; Behavioral: 1:1 Peer Support

Study type: Interventional

Funder types: Other

Identifiers

NCT04930159

NCI-2021-12773 (Registry Identifier)

STUDY00012990

RG1121627 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 3 patient groups

Enhanced usual care

No Intervention group

Description:

Written materials in an appealing package.

Facilitated group support

Active Comparator group

Description:

Weekly group gatherings.

Treatment:

Behavioral: Facilitated group support

1:1 Peer Support

Active Comparator group

Description:

Individual peer support calls.

Treatment:

Behavioral: 1:1 Peer Support