Clinical trial NCT05334732: Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)
Official title: Improving Communication and Adherence in Black Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Black Women
Breast Cancer Survivor
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Georgetown University
First posted: 2022-04-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

Primary outcomes:
measure: Assessing Study Adherence Behaviors- Initiation
timeFrame: 36 Months
measure: Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy.
timeFrame: 36 Months
measure: Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence
timeFrame: 36 Months
Secondary outcomes:
measure: Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making
timeFrame: 36 Months
measure: Assess Perceived Involvement in Care: PCC Outcomes - Perceptions of Doctor Behaviors by determining a more patient-centered encounter vs a more biomedically focused encounter.
timeFrame: 36 Months
measure: 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
timeFrame: 36 Months
measure: Determine Process and Implementation Outcomes
timeFrame: 36 Months
measure: Determine Process and Implementation Outcomes
timeFrame: 36 Months
measure: Determine Process and Implementation Outcomes
timeFrame: 36 Months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Vanessa B Sheppard, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: