Back to resultsMENCORE-2: Audio Recordings to Improve Decision-making in Advanced Prostate Cancer
Primary Purpose
Prostate Cancer, Metastatic Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Consultation audio recording app
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Cancer focused on measuring Consultation audio recordings, Shared decision-making
Eligibility Criteria
Inclusion Criteria:
- 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):
1. UCSF GU medical oncology providers (medical doctor (MD), nurse practitioner (NP), or physician's assistant (PA)), regardless of whether their patient was enrolled
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.
- Prior participation in Mobile Health ElectroNic COnsultation REcording (mENCORE) (participants have already received the intervention).
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Consultation audio recording
Arm Description
Instructions on installation and detailed use of chosen application will be provided before an upcoming oncology visit. Research staff will contact the participant and encourage a "practice" recording session. 15-30 minutes prior to the consultation, research staff will send an anonymous text message to the participants' mobile device with a reminder to record the visit. Three days after the consultation, research staff will send an anonymous text reminder message to the participants' mobile device to listen to the recording.
Outcomes
Primary Outcome Measures
Mean change in docetaxel knowledge score over time
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
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).
Secondary Outcome Measures
Proportion of invited participants who consent to the study
The proportion of participants who consented to the study from the total number of participants contacted will be reported.
Proportion of approached patients' providers who agree to be recorded
The proportion of approached patients' providers who agree to be recorded from the total number of patients' providers approached to participate will be reported.
Mean change in participant-reported anxiety over time
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short form (4a) consists of 4 items addressing patient anxiety with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of anxiety. Participants will be measured at baseline and 7 days post-appointment and compared over time.
Proportion of enrolled participants who create a recording
The proportion of enrolled participants who created a recording of the total number of participants in the study will be reported.
Proportion of enrolled participants who listen to the recording
The proportion of enrolled participants who listen to the recording or read its automatically generated transcript, measured by participant-reported survey at 7 days post-appointment of the total number of participants in the study will be reported.
Proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app
The proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app measured by participant-reported survey at 7 days post-appointment of the total number of participants in the study will be reported.
Proportion of participants who report high shared decision-making effort
High shared decision-making effort will be measured at 7 days post-appointment using the collaboRATE scale. The collaboRATE scale is a 3-item, 10-point Likert scale, where each encounter is scored as either '1' if the response to all three collaboRATE items is 9, or '0' if the response to any of the three collaboRATE items is less than 9. The percentage of all participants with a code of '1' will be calculated.
Proportion of patients who received docetaxel
Docetaxel treatment received at 30 days post-appointment will be reported with a 95% confidence interval will be reported.
Proportion of patients who received docetaxel
Docetaxel treatment received at 60 days post-appointment will be reported with a 95% confidence interval will be reported.
Full Information
NCT ID
NCT05127850
First Posted
November 8, 2021
Last Updated
June 26, 2023
Sponsor
University of California, San Francisco
Collaborators
Conquer Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05127850
Brief Title
MENCORE-2: Audio Recordings to Improve Decision-making in Advanced Prostate Cancer
Official Title
Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Conquer Cancer Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVE:
1. 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:
To evaluate whether provision of a consultation audio recording app improves participant-reported knowledge retention of docetaxel.
To evaluate accuracy of app auto-generated transcription.
To evaluate degree of provider decision support and communication skills.
Participants are set up with an application prior to the first physician visit and then followed-up 7 days, 28 days and 60 days after their physician encounter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Metastatic Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Keywords
Consultation audio recordings, Shared decision-making
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
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Consultation audio recording
Arm Type
Experimental
Arm Description
Instructions on installation and detailed use of chosen application will be provided before an upcoming oncology visit. Research staff will contact the participant and encourage a "practice" recording session. 15-30 minutes prior to the consultation, research staff will send an anonymous text message to the participants' mobile device with a reminder to record the visit. Three days after the consultation, research staff will send an anonymous text reminder message to the participants' mobile device to listen to the recording.
Intervention Type
Behavioral
Intervention Name(s)
Consultation audio recording app
Other Intervention Name(s)
Voice Recording app, Mobile voice recording app, Smartphone voice recording app, Tablet voice recording app
Intervention Description
Smartphone or tablet mobile application which allows for voice recording
Primary Outcome Measure Information:
Title
Mean change in docetaxel knowledge score over time
Description
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.
Time Frame
Up to 2 weeks
Title
Mean change in informed subscale of Decisional Conflict Scale over time
Description
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).
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Proportion of invited participants who consent to the study
Description
The proportion of participants who consented to the study from the total number of participants contacted will be reported.
Time Frame
1 day
Title
Proportion of approached patients' providers who agree to be recorded
Description
The proportion of approached patients' providers who agree to be recorded from the total number of patients' providers approached to participate will be reported.
Time Frame
1 day
Title
Mean change in participant-reported anxiety over time
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short form (4a) consists of 4 items addressing patient anxiety with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of anxiety. Participants will be measured at baseline and 7 days post-appointment and compared over time.
Time Frame
Up to 2 weeks
Title
Proportion of enrolled participants who create a recording
Description
The proportion of enrolled participants who created a recording of the total number of participants in the study will be reported.
Time Frame
Up to 2 weeks
Title
Proportion of enrolled participants who listen to the recording
Description
The proportion of enrolled participants who listen to the recording or read its automatically generated transcript, measured by participant-reported survey at 7 days post-appointment of the total number of participants in the study will be reported.
Time Frame
Up to 2 weeks
Title
Proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app
Description
The proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app measured by participant-reported survey at 7 days post-appointment of the total number of participants in the study will be reported.
Time Frame
Up to 2 weeks
Title
Proportion of participants who report high shared decision-making effort
Description
High shared decision-making effort will be measured at 7 days post-appointment using the collaboRATE scale. The collaboRATE scale is a 3-item, 10-point Likert scale, where each encounter is scored as either '1' if the response to all three collaboRATE items is 9, or '0' if the response to any of the three collaboRATE items is less than 9. The percentage of all participants with a code of '1' will be calculated.
Time Frame
Up to 2 weeks
Title
Proportion of patients who received docetaxel
Description
Docetaxel treatment received at 30 days post-appointment will be reported with a 95% confidence interval will be reported.
Time Frame
Up to 30 days
Title
Proportion of patients who received docetaxel
Description
Docetaxel treatment received at 60 days post-appointment will be reported with a 95% confidence interval will be reported.
Time Frame
Up to 60 days
Other Pre-specified Outcome Measures:
Title
Mean change in docetaxel knowledge score over time
Description
Change in docetaxel knowledge score is measured by participant report of knowledge using a docetaxel knowledge instrument, measured at baseline and 28 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.
Time Frame
Up to 28 days
Title
Auto-generated transcript accuracy
Description
Auto-generated transcript accuracy will be measured by comparing the transcript to research staff transcription of the recording.
Time Frame
Up to 60 days
Title
Quality of decision support and communication
Description
The Brief Decision Support Analysis Tool (DSAT-10) will be applied to recordings to evaluate treating physicians' and practitioners' use of decision support and communication skills with patients, with attention to docetaxel. Encounters are reviewed and scored on factors such as Decision making status, Knowledge of, Values/Preference associated with, Others' involvement with the decision, and Next Steps and given a score ranging from 1-10, with a higher score indicating a greater quality of decisional support.
Time Frame
Up to 60 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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):
1. UCSF GU medical oncology providers (medical doctor (MD), nurse practitioner (NP), or physician's assistant (PA)), regardless of whether their patient was enrolled
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.
Prior participation in Mobile Health ElectroNic COnsultation REcording (mENCORE) (participants have already received the intervention).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UCSF Genitourinary Medical Oncology
Phone
877-827-3222
Email
GUTrials@ucsf.edu
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UCSF Genitourinary Medical Oncology
Phone
877-827-3222
Email
GUTrials@ucsf.edu
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Daniel Kwon, MD
First Name & Middle Initial & Last Name & Degree
Rahul Aggarwal, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Belkora, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MENCORE-2: Audio Recordings to Improve Decision-making in Advanced Prostate Cancer
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