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

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: SIS TALK Back Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05334732

HM20016396 (Other Identifier)

MCC-19-15740

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Sisters Informing Sisters Sessions

Experimental group

Description:

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.

Treatment:

Behavioral: SIS TALK Back Intervention

Enhanced Usual Care

No Intervention group

Description:

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.