Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 2
- 主要终点
- Mean Patient-centered Communication in Advanced Cancer Score
研究概览
简要总结
The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.
详细描述
The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently in clinical practice at participating institutions
- •Oncologist that cares for patients with solid tumors
- •Not planning to leave the practice during the next 6 months
- •Inclusion Criteria: Patients
- •Currently a patient of an enrolled physician
- •Age 21 years or older
- •Diagnosis of advanced cancer
- •Able to understand spoken English (study personnel will read materials to low literacy patients)
- •Inclusion Criteria: Caregivers
- •Caregiver of a patient currently enrolled in the study
- •Age 21 years or older
- •Able to understand spoken English (study personnel will read materials to low literacy patients)
排除标准
- •Non Physicians and physicians who are not oncologists
- •Oncologists who exclusively care for patients with hematological malignancies
- •Prior involvement in health-related coaching interventions
- •Exclusion Criteria: Patients
- •Unable to complete orally-administered surveys in English
- •Hospitalized or in hospice care at the time of recruitment
- •Prior involvement in health-related coaching interventions
- •Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma
- •Exclusion Criteria: Caregiver
- •Unable to complete orally-administered surveys in English
研究组 & 干预措施
Intervention
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
干预措施: Communication training and coaching (Behavioral)
Control
Patients will receive usual care
结局指标
主要结局
Mean Patient-centered Communication in Advanced Cancer Score
时间窗: 3 years
We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions. Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment. We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD. The 4-component z-scores were averaged to form the primary outcome. A higher Z score indicates better communication. The maximum possible Z-score ranged from -0.69 to 20.08.
次要结局
- Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13(7 months)
- Aim 2 Patient Well-being(3 years)
- Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians(3 years)
- Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life(3 years)
- Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment(7 months)
研究者
Ronald Epstein
Professor
University of Rochester