Improving Decision Making for Older Adults With Cancer: A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 6
- 主要终点
- Enrollment rate
研究概览
简要总结
This is a minimal risk, pilot cluster randomized controlled trial (CRT) to determine the feasibility and acceptability of training medical oncologists to use the Best Case/Worst Case-Geriatric Oncology (BC/WC-GeriOnc) communication tool in clinical practice with older adults with cancer.
详细描述
Primary Objective:
I. To assess the feasibility of study procedures and using the BC/WC-GeriOnc communication tool in medical oncology with older adults with cancer.
Secondary Objectives
I. To evaluate the acceptability and appropriateness of using the BC/WC-GeriOnc communication tool.
II. To evaluate BC/WC-GeriOnc intervention fidelity and adherence by oncologists .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Exclusion Criteria for Oncologists:
- •Medical oncologists who practice solely in the inpatient setting are not eligible.
- •Exclusion Criteria for Patients:
- •Plan for UCSF second opinion evaluation only. Patients are eligible if they plan to transfer care to UCSF at the time of enrollment.
- •Planned decision-making discussion via phone only (without video).
- •Patients participating in another cancer communication/decision support intervention study with their medical oncologist.
结局指标
主要结局
Enrollment rate
时间窗: 1 day
Proportion of eligible patients who enroll in the study. An enrollment rate \>=50% will be used to determine overall feasibility, which was selected based on decreased enrollment observed in studies of older adults with cancer during the ongoing 2019 novel coronavirus (COVID-19) pandemic.
Retention rate
时间窗: 3 months
Proportion of oncologists, participants, and caregivers who complete the study. A completion rate of \>=75% study completion excluding drop out due to death will be used to determine overall feasibility.
Duration of audio-recorded decision-making discussions
时间窗: Within 2 weeks after cancer care decision is made for each participating patient
The duration of audio-recorded decision-making discussions in the intervention group will be compared with the duration in the control group. The investigators will compare the duration of the overall patient visit, the decision-making discussion portion of the patient visit, and the decision-making discussion portion of the patient visit plus any subsequent follow-up discussions until the decision is made.
Feasibility of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
时间窗: Within 2 weeks after cancer care decision is made for each participating patient
Oncologists will complete the Feasibility of Intervention Measure, which includes 4 items with responses rated on a 5-point Likert scale from completely disagree to completely agree. The measure is scored by calculating the mean of the responses with a higher score indicating greater feasibility.
Qualitative oncologist-reported feasibility (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
时间窗: Completed once at the end of study participation (approximately 18 months)
Oncologists will participate in one semi-structured interview at study completion to learn about their perspectives on intervention feasibility.
次要结局
- BC/WC-GeriOnc Intervention Fidelity (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Within 2 weeks after cancer care decision is made for each participating patient)
- Practitioner Opinion Survey (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Completed once at the end of study participation (approximately 18 months))
- BC/WC-GeriOnc Intervention Adherence (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Within 2 weeks after cancer care decision is made for each participating patient)
- Acceptability of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Within 2 weeks after cancer care decision is made for each participating patient)
- Intervention Appropriateness Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Within 2 weeks after cancer care decision is made for each participating patient)