Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,996
- 试验地点
- 34
- 主要终点
- Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
研究概览
简要总结
This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.
详细描述
PRIMARY OBJECTIVES:
I. Greater intervention effects on health-related quality of life
SECONDARY OBJECTIVES:
I. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice
OUTLINE: Sites are randomized to 1 of 2 arms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.
- •Patients must have the ability to understand and willingness to provide verbal consent.
- •Participants must speak English, Spanish, Chinese, or Vietnamese.
排除标准
- •Inability to consent to the study
- •Plans to change oncologist within 12 months
- •Employed by the practice site
- •Patients who anticipate moving from the area within 12 months
研究组 & 干预措施
Technology-based supportive cancer care
Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.
干预措施: Receive technology-based supportive cancer care (Other)
Redesigned team-based supportive cancer care
Patients are paired with a health educator who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.
干预措施: Receive redesigned team-based supportive cancer care (Behavioral)
结局指标
主要结局
Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
时间窗: Change in health-related quality of life from baseline to 3 months
Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.
次要结局
- Documentation of symptom discussions (Chart Review)(3, 6, and 12 months after patient enrollment)
- Palliative Care Use (Self-reported and Chart Review)(3, 6, and 12 months after patient enrollment)
- Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42.(Change in satisfaction with care from baseline to 3, 6, and 12 months)
- Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).(Change in health-related quality of life from baseline to 6, and 12 months)
- Change in patient activation using the Patient Activation Measure (PAM-13).(Change in patient activation from baseline to 3, 6, and 12 months)
- Hospice Care Use (Self-reported and Chart Review)(3, 6, and 12 months after patient enrollment)
- Hospitalization Visits (Self-reported and Chart Review)(3, 6, and 12 months after patient enrollment)
- Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD)(Change in satisfaction with decision from baseline to 3, 6, and 12 months)
- Emergency Department Visits (Self-reported and Chart Review)(3, 6, and 12 months after patient enrollment)
- Documentation of goals of care discussions (Chart Review)(3, 6, and 12 months after patient enrollment)
研究者
Manali Indravadan Patel
Assistant Professor of Medicine
Stanford University