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

Официальное название

Improving Communication and Adherence in Black Breast Cancer Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Assessing Study Adherence Behaviors- Initiation [Срок оценки: 36 Months]
• Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy. [Срок оценки: 36 Months]
• Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence [Срок оценки: 36 Months]

Вторичные конечные точки (6)

• Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 36 Months]
• Determine Process and Implementation Outcomes [Срок оценки: 36 Months]
• Determine Process and Implementation Outcomes [Срок оценки: 36 Months]
• Determine Process and Implementation Outcomes [Срок оценки: 36 Months]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 3 центра

• Medstar Georgetown University Hospital — Washington D.C.
• MedStar Washington Hospital Center — Washington D.C.
• Massey Cancer Center — Richmond

Идентификаторы

NCT: NCT05334732 · MCC-19-15740 · HM20016396

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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