MENCORE-2: Audio Recordings to Improve Decision-making in Advanced Prostate Cancer

Sponsor
University of California, San Francisco (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05127850
Collaborator
Conquer Cancer Foundation (Other)
55
Enrollment
1
Location
1
Arm
14.5
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-arm hybrid implementation trial of men with metastatic castrate-resistant prostate cancer (mCRPC) involving a clinician-prompted, patient-administered mobile app tailored for consultation audio recordings.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Consultation audio recording app
N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To evaluate change in participant informed decision-making after provision of a consultation audio recording application.
SECONDARY OBJECTIVES:
  1. Reach. To evaluate the percentage of invited participants who enroll. Reasons for not enrolling will be assessed.

  2. Adoption. To evaluate the percentage of providers who agree to be recorded.

  3. Adoption. To evaluate the percentage of participants who create an audio recording.

  4. Adoption. To evaluate the percentage of participants who listen to the audio recording or read its automatically generated transcript.

  5. Implementation. To evaluate the percentage of participants who report receiving instructions on how to record.

  6. To evaluate participant-reported shared decision-making effort.

  7. To evaluate whether participant-reported anxiety changes after provision of a consultation audio recording app.

  8. 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.

  9. Treatment received.

EXPLORATORY OBJECTIVES:
  1. To evaluate whether provision of a consultation audio recording app improves participant-reported knowledge retention of docetaxel.

  2. To evaluate accuracy of app auto-generated transcription.

  3. To evaluate degree of provider decision support and communication skills.

Participants are set up with the application prior to their first physician visit and then followed-up 7 days, 28 days and 60 days after their physician encounter.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer
Anticipated Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Consultation audio recording

Behavioral: Consultation audio recording app
Instructions on installation and use of Medcorder will be provided before an upcoming oncology visit. Instructions are comprised of a written document, a video tutorial, and a troubleshooting telephone call. A text reminder to record the visit will be sent before the appointment, and a text reminder to listen to the recording will be sent after the appointment. Medcorder is a mobile app available for both iPhone operating systems (iOS) and Android mobile devices that enables participants to record medical consultations
Other Names:
  • Medcorder
  • Outcome Measures

    Primary Outcome Measures

    1. Mean change in docetaxel knowledge score over time [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.

    2. Mean change in informed subscale of Decisional Conflict Scale over time [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).

    Secondary Outcome Measures

    1. Proportion of invited participants who consent to the study [1 day]

      The proportion of participants who consented to the study from the total number of participants contacted will be reported.

    2. Proportion of approached patients' providers who agree to be recorded [1 day]

      The proportion of approached patients' providers who agree to be recorded from the total number of patients' providers approached to participate will be reported.

    3. Mean change in participant-reported anxiety over time [Up to 2 weeks]

      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.

    4. Proportion of enrolled participants who create a recording [Up to 2 weeks]

      The proportion of enrolled participants who created a recording of the total number of participants in the study will be reported.

    5. Proportion of enrolled participants who listen to the recording [Up to 2 weeks]

      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.

    6. Proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app [Up to 2 weeks]

      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.

    7. Proportion of participants who report high shared decision-making effort [Up to 2 weeks]

      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.

    8. Proportion of patients who received docetaxel [Up to 30 days]

      Docetaxel treatment received at 30 days post-appointment will be reported with a 95% confidence interval will be reported.

    9. Proportion of patients who received docetaxel [Up to 60 days]

      Docetaxel treatment received at 60 days post-appointment will be reported with a 95% confidence interval will be reported.

    Other Outcome Measures

    1. Mean change in docetaxel knowledge score over time [Up to 28 days]

      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.

    2. Auto-generated transcript accuracy [Up to 60 days]

      Auto-generated transcript accuracy will be measured by comparing the transcript to research staff transcription of the recording.

    3. Quality of decision support and communication [Up to 60 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Metastatic castration-resistant prostate cancer (mCRPC) with progression per any Prostate Cancer Working Group 3 (PCWG3) criterion (Prostate-specific antigen (PSA), clinical, or radiographic)

    2. Has never received any chemotherapy for prostate cancer.

    3. Current or prior receipt of at least one androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide), with progression on it.

    4. Eligible for docetaxel chemotherapy at any dose level (treating provider's discretion).

    5. 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).

    6. 18 years of age or older.

    7. Able to read, speak, and write in English (the application is in English only)

    8. Has access to and ability to use an iOS or Android smartphone or tablet.

    9. 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.

    10. 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:
    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.

    4. Prior participation in Mobile Health ElectroNic COnsultation REcording (mENCORE) (participants have already received the intervention).

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of California, San FranciscoSan FranciscoCaliforniaUnited States94143

    Sponsors and Collaborators

    • University of California, San Francisco
    • Conquer Cancer Foundation

    Investigators

    • Principal Investigator: Daniel Kwon, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05127850
    Other Study ID Numbers:
    • 21559
    • NCI-2021-11595
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, San Francisco
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021