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

April 30, 2024 updated by: Kemi Doll, University of Washington
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kemi M Doll, MD, MS
  • Phone Number: 206-543-3669
  • Email: kdoll@uw.edu

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama
        • Principal Investigator:
          • Rebecca Arend, MD
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Principal Investigator:
          • Heather Williams, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Navya Nair, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago
        • Principal Investigator:
          • Nita Lee, MD, MPH
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University - New Orleans
        • Principal Investigator:
          • Tara Castellano, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Katherine Stewart, MD
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Medstar Health Research Institute
        • Principal Investigator:
          • Charlotte Gamble, MD MPH
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine
        • Principal Investigator:
          • Eloise Chapman-Davis, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • Victoria Bae-Jump, MD, PhD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Fred Hutch/University of Washington Cancer Consortium
        • Principal Investigator:
          • Kemi M Doll, MD, MSCR
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

The time frame is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board

IPD Sharing Access Criteria

The access criteria is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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