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RecruitingInterventional

Improving Communication and Adherence in Black Breast Cancer Survivors

NCT ID: NCT05334732Sponsor: Virginia Commonwealth UniversityLast updated: 2026-04-08

Summary

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

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.

Arms & interventions

  • BehavioralSIS TALK Back Intervention

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

Outcome measures

Primary

  • Assessing Study Adherence Behaviors- Initiation

    Initiation will be measured for all therapies based on the number of participants starting at least one cycle of prescribed therapy

    Time frame: 36 Months

  • Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy.

    Initiation Delay of therapy will be measured by the number of participant's days from definitive surgery date to the date of her first cycle of adjuvant systemic therapy. Classifications of delay are dichotomized according to published reports (\<60 days primary measure).

    Time frame: 36 Months

  • Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence

    Overall chemotherapy adherence will be measured by the number of participants that complete chemotherapy. Chemotherapy adherence will be measured as having at least 80% or more of the recommended doses. Adherence will be calculated based on the planned and expected number of cycles divided by the number received (i.e., 6 chemotherapy cycles received/8 expected = 75% adherent).

    Time frame: 36 Months

Secondary

  • Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making

    Time frame: 36 Months

  • Assess Perceived Involvement in Care: PCC Outcomes - Perceptions of Doctor Behaviors by determining a more patient-centered encounter vs a more biomedically focused encounter.

    Time frame: 36 Months

  • Assess Perceived Involvement in Care: PCC Outcomes - Perceptions of Patient Behaviors by determining Perceptions of Doctor Behaviors by determining a more patient-centered encounter vs a more biomedically focused encounter

    Time frame: 36 Months

  • Determine Process and Implementation Outcomes

    Time frame: 36 Months

  • Determine Process and Implementation Outcomes

    Time frame: 36 Months

  • Determine Process and Implementation Outcomes

    Time frame: 36 Months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

Recruiting
Hurtado de Mendoza · Contact
Lucile Adams-Campbell · Principal Investigator

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010

Recruiting

Massey Cancer Center

Richmond, Virginia, 23298

Recruiting
Vanessa B Sheppard, PhD · Contact