Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)

NCT ID: NCT05334732

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-02-28

Brief Summary

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The purpose of this study is to test an evidence-based intervention designed to increase adherence to systemic therapy in Black women compared to enhanced usual care.

Detailed Description

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Black women continue to experience worse breast cancer outcomes, which may be due to inadequate adherence to systemic therapies that can be improved via patient-centered communication. We developed and piloted the Sisters Informing SistersSM (SIS) intervention (survivor-led skill-building sessions and culturally tailored materials to activate Black breast cancer survivors in their medical encounters) and obtained promising findings. This project will compare in a two-arm RCT the impact of SIS vs. enhanced usual care (treatment recommendation summary form) on patient-centered communication and systemic treatment adherence; SIS tools may be integrated within existing clinical and support services.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Sisters Informing Sisters Sessions

The intervention is peer-based and in concert with our theoretical model, builds upon positive role-modeling of the survivor coach to the patient, addresses behavioral expectations/capacities, and uses Motivational Interviewing (MI) techniques. The intervention includes a culturally relevant coach's manual and a patient workbook that will be used to facilitate the coaching sessions.

Group Type EXPERIMENTAL

SIS TALK Back Intervention

Intervention Type BEHAVIORAL

The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.

Enhanced Usual Care

Women in the EUC arm will receive usual care that includes standardized information in the public domain (NCI treatment information booklet). This booklet was chosen to provide women with national-level recommendations regarding treatment recommendations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SIS TALK Back Intervention

The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-identify as Black
* Newly diagnosed (\~4 weeks post-definitive surgery and prior to initiation of adjuvant chemotherapy or endocrine therapy) patients (stage I-III)
* Eligible for chemotherapy or endocrine therapy according to NCCN guidelines, but have not initiated systemic therapy
* Ability to read and speak English
* Ability to provide meaningful consent as determined by trained study personnel and/or a member of the patient's care team
* No prior cancer treatment (other than skin cancer) in the two years preceding enrollment
* Physicians Must be a license doctor of study patient(s)
* Ability to speak English
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanessa B Sheppard, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Massey Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vanessa B Sheppard, Ph.D

Role: CONTACT

804-682-2700

Yvonne D Cummings, BS

Role: CONTACT

804-828-0643

Facility Contacts

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Hurtado de Mendoza

Role: primary

Vanessa B Sheppard, PhD

Role: primary

804-628-2700

Other Identifiers

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HM20016396

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-19-15740

Identifier Type: -

Identifier Source: org_study_id

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