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Recruiting NCT05334732

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SIS TALK Back Intervention.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Improving Communication and Adherence in Black Breast Cancer Survivors

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.

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.

Interventions

  • Behavioral SIS TALK Back Intervention
    The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.

Primary outcome measures

  • Assessing Study Adherence Behaviors- Initiation [Time frame: 36 Months]
  • Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy. [Time frame: 36 Months]
  • Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence [Time frame: 36 Months]
Secondary outcome measures (6)
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 3 centers
  • Medstar Georgetown University Hospital — Washington D.C.
  • MedStar Washington Hospital Center — Washington D.C.
  • Massey Cancer Center — Richmond

Identifiers

NCT: NCT05334732 · MCC-19-15740 · HM20016396

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗