mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer: a Feasibility Trial of a Patient Decision Support Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Proportion of enrolled participants who utilized the application
研究概览
简要总结
Patients surviving with advanced prostate cancer frequently encounter time points in their disease course that require choosing among multiple options regarding systemic therapy. Interventions to improve shared decision-making through patient support measures such as question listing, and audio recording and summarizing of consultations have been shown to improve patient-reported measures of decision making quality, e.g. decreased decisional conflict and regret. However, the feasibility of consultation recording and summarizing with mobile health (mHealth) technology on patient-owned smartphones is unknown. The investigators will conduct a single-arm trial to determine feasibility and acceptability of a clinician-prompted, patient administered smartphone audio recording application and a service to summarize the recordings (Patient Support Corps or PSC), in improving decision-making quality among patients with chemotherapy-naive, progressive, metastatic castration-resistant prostate cancer (mCRPC). This trial will inform the design and conduct of a larger trial evaluating broader scale implementation of this intervention.
详细描述
The intervention (provision of instructions on how to install/use the app and how to share the recording with the PSC) will take place 7-60 days before the upcoming oncology consultation. PSC will provide a summary within a week of the consultation.
Primary Objective:
To determine the percentage of enrolled participants who use a clinician-prompted, patient-administered smartphone application to create an audio recording of an outpatient oncology visit.
Secondary Objectives:
- To determine the percentage of enrolled participants who listen to the audio recording within 1 week after the visit.
- To determine the percentage of enrolled participants who request and receive a written summary of the consultation from the Patient Support Corps within 1 week after the visit.
- To determine whether audio recording and summarization change decision-making quality measures.
- To determine whether audio recording and summarization change provider-reported workload and other outcomes.
- To determine whether audio recording and summarization change the frequency of follow-up communication between participant and clinic staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer of any histology.
- •Metastatic castrate-resistant Prostate Cancer (mCRPC)
- •Progression per any Prostate Cancer Working Group 3(PCWG3) criterion.
- •Has never received chemotherapy
- •Currently receiving or has previously received any androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide) that was discontinued due to progression
- •18 years of age or older.
- •Able to read, speak, and write in English.
- •Has an upcoming genitourinary (GU) medical oncology appointment (in-person or Zoom video visit) at University of California, San Francisco (UCSF) within 7-60 days of enrollment.
- •Has access to and ability to use an iPhone (iOS) or Android smartphone.
- •Patient's UCSF oncology provider agrees to be recorded.
排除标准
- •Lack of decision-making capacity to provide consent to this trial.
- •Uncorrectable hearing or visual impairment hindering the ability to perform necessary tasks in the trial.
- •Any neurocognitive or psychiatric disorder hindering the ability to perform necessary tasks in the trial.
结局指标
主要结局
Proportion of enrolled participants who utilized the application
时间窗: Up to 2 weeks after the appointment
Proportion of enrolled participants who create a complete audio consultation recording of the appointment using the application, measured by application metrics, at 1 week post-consultation along with 95% confidence interval will be reported.
次要结局
- Proportion of enrolled participants who listened to audio recording within 1 week after the visit(Up to 2 weeks after the appointment)
- Proportion of enrolled participants who obtain written summary of the consultation(Up to 2 weeks after the appointment)
- Mean score of participant reported Decision Regret Scale (DRS)(Up to 2 weeks after the appointment)
- Mean change in number of participant-initiated telephone call or portal message encounters over time(Baseline and up to 2 weeks after the appointment)
- Mean participant-reported CollaboRATE scores(Up to 2 weeks after the appointment)
- Mean perceived change in provider-patient relationship quality(Up to 2 weeks after the appointment)
- Mean change in scores on the Informed subscale of the Decisional Conflict Scale (DCS) from baseline(Baseline and up to 2 weeks after the appointment)
- Mean perceived change in work burden provider-reported workload and other outcomes(Up to 2 weeks after the appointment)