Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Behavioral: SIS TALK Back Intervention
    The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.
No Intervention
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.

Recruiting Locations

Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Hurtado de Mendoza
ahd28@georgetown.edu

More Details

Status
Recruiting
Sponsor
Virginia Commonwealth University

Study Contact

Vanessa B Sheppard, Ph.D
804-682-2700
vanessa.sheppard@vcuhealth.org

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.