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

N/AActive Not RecruitingNCT05334732

Virginia Commonwealth University225 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

225

Conditions

Breast Cancer

Interventions

SIS TALK Back InterventionBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Medstar Georgetown University Hospital

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

MedStar Washington Hospital Center

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

Massey Cancer Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

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 Outcomes

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

The number of participants level of engagement in decision-making will be assessed by utilizing The Perceived Involvement in Care (PCC) 13-Item scale. PCC will be assessed via direct observation of medical encounters through a quantitative analysis of audiotaped visits.

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.

The number of participants level of engagement in perceptions of doctor behaviors will be assessed by utilizing The Perceived Involvement in Care (PCC) 13-Item scale. PCC will be assessed via direct observation of medical encounters through a quantitative analysis of audiotaped visits. A value \>1 indicates a more patient-centered encounter, whereas a value \<1 indicates a more biomedically focused encounter.

Data from ClinicalTrials.gov

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