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

Primary Purpose

Endometrial Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Facilitated group support

1:1 Peer Support

About this trial

This is an interventional supportive care trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:
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
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 endometroid 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

Sites / Locations

University of AlabamaRecruiting
University of Arkansas for Medical SciencesRecruiting
University of MiamiRecruiting
The University of ChicagoRecruiting
Louisiana State University - New OrleansRecruiting
Johns Hopkins UniversityRecruiting
MedStar Health Research InstituteRecruiting
Weill Cornell MedicineRecruiting
University of North CarolinaRecruiting
Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Enhanced usual care

Facilitated group support

1:1 Peer Support

Arm Description

Written materials in an appealing package.

Weekly group gatherings.

Individual peer support calls.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04930159

First Posted

June 11, 2021

Last Updated

July 5, 2023

Sponsor

University of Washington

Collaborators

Patient-Centered Outcomes Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04930159

Brief Title

Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Acronym

SISTER

Official Title

Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Enhanced usual care

Arm Type

No Intervention

Arm Description

Written materials in an appealing package.

Arm Title

Facilitated group support

Arm Type

Active Comparator

Arm Description

Weekly group gatherings.

Arm Title

1:1 Peer Support

Arm Type

Active Comparator

Arm Description

Individual peer support calls.

Intervention Type

Behavioral

Intervention Name(s)

Facilitated group support

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

1:1 Peer Support

Intervention Description

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.

Primary Outcome Measure Information:

Title

Treatment completion (relative dose)

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Patient-reported social isolation (SPS-24)

Description

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kemi M Doll, MD, MS

Phone

206-543-3669

kdoll@uw.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Liz Sage, MPH

Phone

206-543-9542

lizsage@uw.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kemi M Doll, MD, MS

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Rebecca Arend, MD

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Heather Williams, MD

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage, MPH

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Adbulrahman Sinno, MD

Facility Name

The University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Nita Lee, MD, MPH

Facility Name

Louisiana State University - New Orleans

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Navya Nair, MD

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21218

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Anna Beavis, MD, MPH

Facility Name

MedStar Health Research Institute

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage, MPH

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Charlotte Gamble, MD MPH

Facility Name

Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Eloise Chapman-Davis, MD

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage

Phone

206-543-9542

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Victoria Bae-Jump, MD, PhD

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liz Sage, MPH

Phone

206-685-4361

lizsage@uw.edu

First Name & Middle Initial & Last Name & Degree

Kemi M Doll, MD, MSCR

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

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