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mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer (mENCORE)

Primary Purpose

Metastatic Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medcorder
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metastatic Prostate Cancer focused on measuring Shared decision-making, Consultation audio recordings, Mobile health, mHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Prostate cancer of any histology.
  2. Metastatic castrate-resistant Prostate Cancer (mCRPC)
  3. Progression per any Prostate Cancer Working Group 3(PCWG3) criterion.
  4. Has never received chemotherapy
  5. Currently receiving or has previously received any androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide) that was discontinued due to progression
  6. 18 years of age or older.
  7. Able to read, speak, and write in English.
  8. 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.
  9. Has access to and ability to use an iPhone (iOS) or Android smartphone.
  10. Patient's UCSF oncology provider agrees to be recorded.

Exclusion Criteria:

  1. Lack of decision-making capacity to provide consent to this trial.
  2. Uncorrectable hearing or visual impairment hindering the ability to perform necessary tasks in the trial.
  3. Any neurocognitive or psychiatric disorder hindering the ability to perform necessary tasks in the trial.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient Decision Support

Arm Description

Instructions will be provided for installation and use of a smartphone recording app 7-60 days before an oncology consultation. Participants will share the recording with the Patient Support Corps (PSC), who will summarize the recording, send it to the participant's oncologist for review, then return an annotated summary to the participant within a week of the consultation.

Outcomes

Primary Outcome Measures

Proportion of enrolled participants who utilized the application
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

Proportion of enrolled participants who listened to audio recording within 1 week after the visit
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
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 participant-reported CollaboRATE scores
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 score of participant reported Decision Regret Scale (DRS)
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 scores on the Informed subscale of the Decisional Conflict Scale (DCS) from baseline
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
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".
Mean perceived change in provider-patient relationship quality
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 number of participant-initiated telephone call or portal message encounters over time
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).

Full Information

First Posted
September 4, 2020
Last Updated
May 28, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04545697
Brief Title
mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer
Acronym
mENCORE
Official Title
mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer: a Feasibility Trial of a Patient Decision Support Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. Participants will be followed via electronic medical record review for 2 weeks after consultation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
Shared decision-making, Consultation audio recordings, Mobile health, mHealth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Decision Support
Arm Type
Experimental
Arm Description
Instructions will be provided for installation and use of a smartphone recording app 7-60 days before an oncology consultation. Participants will share the recording with the Patient Support Corps (PSC), who will summarize the recording, send it to the participant's oncologist for review, then return an annotated summary to the participant within a week of the consultation.
Intervention Type
Other
Intervention Name(s)
Medcorder
Intervention Description
Medcorder is a smartphone app that is HIPAA compliant for the use of on patient recordings of consults with healthcare providers.
Primary Outcome Measure Information:
Title
Proportion of enrolled participants who utilized the application
Description
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.
Time Frame
Up to 2 weeks after the appointment
Secondary Outcome Measure Information:
Title
Proportion of enrolled participants who listened to audio recording within 1 week after the visit
Description
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.
Time Frame
Up to 2 weeks after the appointment
Title
Proportion of enrolled participants who obtain written summary of the consultation
Description
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.
Time Frame
Up to 2 weeks after the appointment
Title
Mean participant-reported CollaboRATE scores
Description
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.
Time Frame
Up to 2 weeks after the appointment
Title
Mean score of participant reported Decision Regret Scale (DRS)
Description
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.
Time Frame
Up to 2 weeks after the appointment
Title
Mean change in scores on the Informed subscale of the Decisional Conflict Scale (DCS) from baseline
Description
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.
Time Frame
Baseline and up to 2 weeks after the appointment
Title
Mean perceived change in work burden provider-reported workload and other outcomes
Description
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".
Time Frame
Up to 2 weeks after the appointment
Title
Mean perceived change in provider-patient relationship quality
Description
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".
Time Frame
Up to 2 weeks after the appointment
Title
Mean change in number of participant-initiated telephone call or portal message encounters over time
Description
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).
Time Frame
Baseline and up to 2 weeks after the appointment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Kwon, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer

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