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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05127850
Recruitment Status : Recruiting
First Posted : November 19, 2021
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Conquer Cancer Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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 disease Intervention/treatment Phase
Prostate Cancer Metastatic Prostate Cancer Metastatic Castration-resistant Prostate Cancer Behavioral: Consultation audio recording app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : March 22, 2022
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/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 Name: Medcorder




Primary Outcome Measures :
  1. Mean change in docetaxel knowledge score over time [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05127850


Contacts
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Contact: UCSF Genitourinary Medical Oncology 877-827-3222 GUTrials@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: UCSF Genitourinary Medical Oncology    877-827-3222    GUTrials@ucsf.edu   
Contact       cancertrials@ucsf.edu   
Principal Investigator: Daniel Kwon, MD         
Sub-Investigator: Rahul Aggarwal, MD         
Sub-Investigator: Jeffrey Belkora, PhD         
Sponsors and Collaborators
University of California, San Francisco
Conquer Cancer Foundation
Investigators
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Principal Investigator: Daniel Kwon, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05127850    
Other Study ID Numbers: 21559
NCI-2021-11595 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Consultation audio recordings
Share decision-making
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases