RecruitingRecruiting
Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)
NCT05334732 · Virginia Commonwealth University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Improving Communication and Adherence in Black Breast Cancer Survivors
About this study
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.
Eligibility 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
Enrollment target: 250 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-03-01
Estimated completion: 2027-02-28
Last updated: 2026-04-08
Interventions
Behavioral: SIS TALK Back Intervention
Primary outcomes
- • Assessing Study Adherence Behaviors- Initiation (36 Months)
- • Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy. (36 Months)
- • Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence (36 Months)
Sponsor
Virginia Commonwealth University · other
With: Georgetown University
Contacts & investigators
ContactVanessa B Sheppard, Ph.D · contact · vanessa.sheppard@vcuhealth.org · 804-682-2700
ContactYvonne D Cummings, BS · contact · yvonne.cummings@vcuhealth.org · 804-828-0643
InvestigatorVanessa B Sheppard, Ph.D · principal_investigator, Virginia Commonwealth University
All locations (3)
Medstar Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
MedStar Washington Hospital CenterRecruiting
Washington D.C., District of Columbia, United States
Massey Cancer CenterRecruiting
Richmond, Virginia, United States