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Prostate CancerNCT05127850

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

A study testing Consultation audio recording app in people with Prostate Cancer and Metastatic Prostate Cancer, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Consultation audio recording app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
22 Mar 2022to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.
  • 1. UCSF GU medical oncology providers (medical doctor (MD), nurse practitioner (NP), or physician's assistant (PA)), regardless of whether their patient was enrolled

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer

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.

Read the 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 an application prior to the first physician visit and then followed-up 7 days, 28 days and 60 days after their physician encounter.

Being tested
Consultation audio recording app
Keywords
Consultation audio recordings, Shared decision-making
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Consultation audio recording appBehavioural

    Also called Voice Recording app, Mobile voice recording app, Smartphone voice recording app, Tablet voice recording app

    Smartphone or tablet mobile application which allows for voice recording

Study groups in NCT05127850
Study groupRoleWhat they receive
Consultation audio recordingExperimentalInstructions 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.
Receives: Behavioral: Consultation audio recording app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 weeks

  2. 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).

    Measured: Up to 2 weeks

Secondary outcomes (9)

  1. 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.

    Measured: 1 day

  2. 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.

    Measured: 1 day

  3. 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.

    Measured: Up to 2 weeks

  4. 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.

    Measured: Up to 2 weeks

  5. 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.

    Measured: Up to 2 weeks

  6. 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.

    Measured: Up to 2 weeks

  7. 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.

    Measured: Up to 2 weeks

  8. 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.

    Measured: Up to 30 days

  9. 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.

    Measured: Up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start22 Mar 2022
  3. Primary completion16 Feb 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05127850
Sponsor's protocol ID
21559
Other IDs
NCI-2021-11595
Status last verified
May 2024
First submitted
8 Nov 2021
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kwon DH, Trihy L, Darvish N, Hearst E, Sumra S, Borno HT, Bose R, Chou J, de Kouchkovsky I, Desai A, Ekstrand B, Friedlander T, Kaur G, Koshkin VS, Nesheiwat S, Sepucha K, Small EJ, Aggarwal RR, Belkora J. Patients Can Administer Mobile Audio Recordings to Increase Knowledge in Advanced Prostate Cancer. Cancer Med. 2024 Nov;13(22):e70433. doi: 10.1002/cam4.70433.

    PubMed 39569542

Questions about this trial

What is this clinical trial studying?

A study testing Consultation audio recording app in people with Prostate Cancer and Metastatic Prostate Cancer, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in docetaxel knowledge score over time (time frame: Up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05127850, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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