Clinical trial NCT04930159: Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
Official title: Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-06-18
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment completion (relative dose)
timeFrame: 6 months
Secondary outcomes:
measure: Patient-reported social isolation (SPS-24)
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University - New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Columbia
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: University of Washington
name: Kemi M Doll, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: