Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Mean change in docetaxel knowledge score over time
研究概览
简要总结
This is a single-arm hybrid implementation trial of men with metastatic castrate-resistant prostate cancer (mCRPC) involving a patient-administered mobile app for consultation audio recordings.
详细描述
PRIMARY OBJECTIVE:
- To evaluate change in participant informed decision-making after provision of a consultation audio recording application.
SECONDARY OBJECTIVES:
- Reach. To evaluate the percentage of invited participants who enroll. Reasons for not enrolling will be assessed.
- Adoption. To evaluate the percentage of providers who agree to be recorded.
- Adoption. To evaluate the percentage of participants who create an audio recording.
- Adoption. To evaluate the percentage of participants who listen to the audio recording or read its automatically generated transcript.
- Implementation. To evaluate the percentage of participants who report receiving instructions on how to record.
- To evaluate participant-reported shared decision-making effort.
- To evaluate whether participant-reported anxiety changes after provision of a consultation audio recording app.
- To evaluate barriers, facilitators, and experiences of recording app use, particularly in the context of treatment decision-making by conducting participant interviews, provider surveys, and interviews with providers.
- Treatment received.
EXPLORATORY OBJECTIVES:
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
- •Metastatic castration-resistant prostate cancer (mCRPC) with progression per any Prostate Cancer Working Group 3 (PCWG3) criterion (Prostate-specific antigen (PSA), clinical, or radiographic)
- •Has never received any chemotherapy for prostate cancer.
- •Current or prior receipt of at least one androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide), with progression on it.
- •Eligible for docetaxel chemotherapy at any dose level (treating provider's discretion).
- •Has an upcoming genitourinary (GU) medical oncology appointment (in-person, telephone, or Zoom video visit) at University of California, San Francisco (UCSF) within 7-60 days of enrollment, during which next-line treatment options are anticipated to be discussed (treating provider's discretion).
- •18 years of age or older.
- •Able to read, speak, and write in English (the application is in English only)
- •Has access to and ability to use an iOS or Android smartphone or tablet.
- •For video visits only: has access to and ability to use a second device (e.g., desktop, laptop, smartphone, tablet, etc.) that will run a Zoom video visit.
- •Patient's provider of the upcoming appointment in #5 agrees to be recorded.
- •Inclusion criteria (provider participants):
- •UCSF GU medical oncology providers (medical doctor (MD), nurse practitioner (NP), or physician's assistant (PA)), regardless of whether their patient was enrolled
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.
- •Prior participation in Mobile Health ElectroNic COnsultation REcording (mENCORE) (participants have already received the intervention).
结局指标
主要结局
Mean change in docetaxel knowledge score over time
时间窗: Up to 2 weeks
Change in docetaxel knowledge score is measured by participant report of knowledge using a docetaxel knowledge instrument, measured at baseline and 7 days post-appointment. The instrument was developed based on facts that patients and providers deem are important when making a treatment decision that includes docetaxel as an option for mCRPC (e.g., disease, prognosis, risks, benefits, alternatives). The score is standardized, ranging from from 0 to 100, with higher scores indicating a greater knowledge in docetaxel. Mean change in scores will be reported, as well as standard deviations.
Mean change in informed subscale of Decisional Conflict Scale over time
时间窗: Up to 2 weeks
The informed subscale of the Decisional Conflict Scale is comprised of 3 items given a score value of 0 = 'strongly agree to 4 = 'strongly disagree'. The items are summed, divided by 3, and then multiplied by 25. Scores range from 0 (feels extremely informed) to 100 (feels extremely uninformed).
次要结局
- Proportion of invited participants who consent to the study(1 day)
- Mean change in participant-reported anxiety over time(Up to 2 weeks)
- Proportion of approached patients' providers who agree to be recorded(1 day)
- Proportion of enrolled participants who listen to the recording(Up to 2 weeks)
- Proportion of patients who received docetaxel(Up to 60 days)
- Proportion of enrolled participants who create a recording(Up to 2 weeks)
- Proportion of participants who report high shared decision-making effort(Up to 2 weeks)
- Proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app(Up to 2 weeks)