mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer
- Conditions
- Metastatic Prostate Cancer
- Registration Number
- NCT04545697
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
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:
1. To determine the percentage of enrolled participants who listen to the audio recording within 1 week after the visit.
2. 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.
3. To determine whether audio recording and summarization change decision-making quality measures.
4. To determine whether audio recording and summarization change provider-reported workload and other outcomes.
5. To determine whether audio recording and summarization change the frequency of follow-up communication between participant and clinic staff.
Participants will be followed via electronic medical record review for 2 weeks after consultation
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of enrolled participants who utilized the application 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.
- Secondary Outcome Measures
Name Time Method 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 listen to the recording, measured by participant-reported survey at 1 week post-consultation along with 95% confidence interval will be reported.
Proportion of enrolled participants who obtain written summary of the consultation Up to 2 weeks after the appointment Proportion of enrolled participants who request and receive a written summary of the consultation from the Patient Support Corps (PSC) within 1 week after the visit along with 95% confidence interval will be reported.
Mean score of participant reported Decision Regret Scale (DRS) Up to 2 weeks after the appointment The DRS is a 5-item questionnaire where participants are asked to reflect on a past decision, and then asked to indicated the extent to which they agree or disagree with the statement in the regret scale by indication a number from 1 (Strongly) to 5 (Strongly Disagree) that best indicated their level of agreement. Scores are converted to a 0-100 scale with a lower scores indicating less regret.
Mean change in number of participant-initiated telephone call or portal message encounters over time Baseline and up to 2 weeks after the appointment Changes in the frequency of follow-up communication between participant and clinic staff in the electronic health record from baseline (2 weeks pre-consultation to consultation) to post-consultation (consultation to 2 weeks post-consultation).
Mean participant-reported CollaboRATE scores Up to 2 weeks after the appointment The CollaboRATE is a 3-item questionnaire developed to measure shared decision making in reference to the most recent appointment the participant may have had with the oncologist.
The questions are as follows: (i) How much effort was made to help you understand your health issues? (ii) How much effort was made to listen to what matters most to you about your health is-sues? (iii) How much effort was made to include what matters most to you in choosing what to do next? Each response ranges from a score of 0-9, with a response of 0 = "No effort was made" and 9="Every effort was made". Higher total scores represent more shared decision making.Mean perceived change in provider-patient relationship quality Up to 2 weeks after the appointment The change in provider-patient relationship quality will be determined using a provider-reported survey to determine whether audio recording produced a change in the provider patient relationship at 1 week post-consultation among providers with enrolled participants. There are 5 possible responses: "Negatively", "Somewhat Negatively", "No change", "Somewhat Positively", and "Positively".
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 The "Informed" subscale of the DCS consists of 3 items which measure the degree that the participant feel informed, with scores that range from 0 (strongly agree) to 4 (Strongly disagree). Scores are summed and then converted to a scale of 0-100, with lower indicating a greater degree of feeling informed. For analyzing changes in DCS information subscale, a two-tailed paired sample t-test will be used to determine whether the mean difference between pre- and post-consultation survey scores is 0 or not.
Mean perceived change in work burden provider-reported workload and other outcomes Up to 2 weeks after the appointment The change in work burden will be determined using a provider-reported workload survey to determine whether audio recording produced a change in work burden at 1 week post-consultation among providers with enrolled participants. There are 5 possible responses: "Decreased work", "No Change", "A little more work", "Some more work", and "A lot more work".
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of California, San Francisco🇺🇸San Francisco, California, United States