Values Assessment Tailored for Women With Metastatic Breast Cancer and Their Caregivers: Adaptation and Pilot Study of a Values Assessment Tool (VAsT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Decisional engagement
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of values assessment tool on patient and caregiver perception of decisional conflict, and communication with their oncology clinician.
详细描述
Incorporating patient values into shared decision-making is essential for individuals diagnosed with metastatic cancer. This is especially critical for women who identify as Black/African American, Latinx/Hispanic, or American Indian/Alaskan Native, as research indicates these groups face a higher risk of poor prognostic communication, worse health outcomes, and increased likelihood of metastatic cancer diagnoses compared to non-Hispanic White adults.
Black/African American women in the South, including North Carolina, experience the highest breast cancer mortality rates in the United States. In North Carolina, the majority of women diagnosed with metastatic breast cancer (mBC) are either non-Hispanic White (159 per 100,000) or Black/African American (164 per 100,000). This study aims to ensure that at least 40% of participants are Black/African American women.
While the Short Graphic Values History (SGVH) tool has been used in general ambulatory care, it has not been tested or adapted for use in cancer care settings. Based on interviews with individuals living with mBC and their care partners, a new Values Assessment Tool (VAsT) has been developed for integration into cancer care.
This single-arm prospective study will enroll 40 women with mBC and their caregivers. Baseline data will be collected at diagnosis, followed by deployment of the VAsT in clinic settings. Follow-up feedback will be obtained to assess real-world usability and relevance of the tool in supporting shared decision-making in cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥18 years
- •Diagnosed with metastatic breast cancer.
- •Understand and read English.
- •Receive care or anticipate receiving care at the North Carolina Cancer Hospital ambulatory cancer clinic or affiliated community cancer clinic.
- •Able to understand and participate in study procedures for length of study.
排除标准
- •All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:
- •Unable to provide consent, unable to communicate verbally.
- •Unable to understand or read English.
- •Enrolled in hospice care.
研究组 & 干预措施
Values assessment tool
Participants are assessed at baseline and every clinic visit for 3 months
干预措施: Values Assessment Tool (Behavioral)
结局指标
主要结局
Decisional engagement
时间窗: Baseline and every clinic visit for 3 months
Values Assessment Tool participants will be assessed using decisional engagement, Patient-Centered Communication in Cancer Care (PCC-Ca) 36. Each item included in the PCC-Ca instrument consists of a question stem and five response options. The response options are scored from 1 to 5, with higher scores representing better communication; for example, where 1 = Never and 5 = Always. There are no reverse-scored items. Some items have a sixth "does not apply" option. This response is not scored.
Decisional conflict
时间窗: Baseline and every clinic visit for 3 months
Decisional Conflict will be assessed using the Decisional Conflict Scale (10-item low literacy version). Scoring and Interpretation: Items are given a score value of: 0 = 'yes'; 2 = 'unsure'; 4 = 'no' Total Score: 10 items \[items 1-10 inclusive\] are: a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]
Communication perceptions
时间窗: Baseline and every clinic visit for 3 months
Communication perceptions will be assessed using Patient-Centered Communication in Cancer Care (PCC-Ca) 36. Each item included in the PCC-Ca instrument consists of a question stem and five response options. The response options are scored from 1 to 5, with higher scores representing better communication; for example, where 1 = Never and 5 = Always. There are no reverse-scored items. Some items have a sixth "does not apply" option. This response is not scored.
次要结局
- Shared decision making evaluation(Baseline and 3 months)
- The number of participants who started and completed(Baseline and 3 months)