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

• ClinicalTrials.gov Identifier: NCT04930159
• Recruitment Status: Recruiting
• First Posted: June 18, 2021
• Last Update Posted: May 2, 2024
• Sponsor: University of Washington
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Kemi Doll, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Endometrial Cancer	Behavioral: Facilitated group support; Behavioral: 1:1 Peer Support	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: March 31, 2025
• Estimated Study Completion Date: September 30, 2025

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Enhanced usual care; Written materials in an appealing package.
Active Comparator: Facilitated group support; Weekly group gatherings.	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.
Active Comparator: 1:1 Peer Support; Individual peer support calls.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Treatment completion (relative dose) [ Time Frame: 6 months ]
   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.

Secondary Outcome Measures :

1. Patient-reported social isolation (SPS-24) [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Kemi M Doll, MD, MS; 206-543-3669; kdoll@uw.edu

Contact: SISTER team; 1-844-374-7837; sisterstudy@uw.edu

Locations

United States, Alabama

University of Alabama; Recruiting

Birmingham, Alabama, United States, 35294

Contact: SISTER team 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Rebecca Arend, MD

United States, Arkansas

University of Arkansas for Medical Sciences; Recruiting

Little Rock, Arkansas, United States, 72205

Contact 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Heather Williams, MD

United States, Florida

University of Miami; Recruiting

Miami, Florida, United States, 33136

Contact: SISTER team 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Navya Nair, MD

United States, Illinois

The University of Chicago; Recruiting

Chicago, Illinois, United States, 60637

Contact: SISTER team 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Nita Lee, MD, MPH

United States, Louisiana

Louisiana State University - New Orleans; Recruiting

New Orleans, Louisiana, United States, 70112

Contact: SISTER team 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Tara Castellano, MD

United States, Maryland

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 21218

Contact: SISTER study 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Katherine Stewart, MD

MedStar Health Research Institute; Recruiting

Columbia, Maryland, United States, 21044

Contact: SISTER team 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Charlotte Gamble, MD MPH

United States, New York

Weill Cornell Medicine; Recruiting

New York, New York, United States, 10021

Contact: SISTER team 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Eloise Chapman-Davis, MD

United States, North Carolina

University of North Carolina; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: SISTER team 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Victoria Bae-Jump, MD, PhD

United States, Washington

Fred Hutch/University of Washington Cancer Consortium; Recruiting

Seattle, Washington, United States, 98105

Contact: SISTER team 844-374-7837 sisterstudy@uw.edu

Principal Investigator: Kemi M Doll, MD, MSCR

Sponsors and Collaborators

University of Washington

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Kemi M Doll, MD, MS; University of Washington

More Information

• Responsible Party: Kemi Doll, Assistant Professor, School of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT04930159
• Other Study ID Numbers: STUDY00012990; RG1121627 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ); NCI-2021-12773 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• First Posted: June 18, 2021
• Last Update Posted: May 2, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Only de-identified data will be shared with other researchers. Researchers will be required to receive approval from the SISTER Advocate Advisory Board to receive data.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: The time frame is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board
• Access Criteria: The access criteria is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Endometrial Neoplasms; Recurrence; Disease Attributes; Pathologic Processes; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases