Improving Communication and Adherence in Black Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 225
- 试验地点
- 6
- 主要终点
- Assessing Study Adherence Behaviors- Initiation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Sisters Informing Sisters Sessions
The intervention is peer-based and in concert with our theoretical model, builds upon positive role-modeling of the survivor coach to the patient, addresses behavioral expectations/capacities, and uses Motivational Interviewing (MI) techniques. The intervention includes a culturally relevant coach's manual and a patient workbook that will be used to facilitate the coaching sessions.
干预措施: SIS TALK Back Intervention (Behavioral)
Enhanced Usual Care
Women in the EUC arm will receive usual care that includes standardized information in the public domain (NCI treatment information booklet). This booklet was chosen to provide women with national-level recommendations regarding treatment recommendations.
结局指标
主要结局
Assessing Study Adherence Behaviors- Initiation
时间窗: 36 Months
Initiation will be measured for all therapies based on the number of participants starting at least one cycle of prescribed therapy
Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy.
时间窗: 36 Months
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).
Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence
时间窗: 36 Months
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).
次要结局
- 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(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.(36 Months)
- Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making(36 Months)
- Determine Process and Implementation Outcomes(36 Months)