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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05127850
• Other study ID #: 21559
• Secondary ID: NCI-2021-11595
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: April 30, 2024
• Est. primary completion date: February 18, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Metastatic Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Consultation audio recording app
Smartphone or tablet mobile application which allows for voice recording

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 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.	Up to 28 days
Other	Auto-generated transcript accuracy	Auto-generated transcript accuracy will be measured by comparing the transcript to research staff transcription of the recording.	Up to 60 days
Other	Quality of decision support and communication	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.	Up to 60 days
Primary	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.	Up to 2 weeks
Primary	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).	Up to 2 weeks
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	Up to 2 weeks
Secondary	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.	Up to 2 weeks
Secondary	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.	Up to 2 weeks
Secondary	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.	Up to 2 weeks
Secondary	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.	Up to 2 weeks
Secondary	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.	Up to 30 days
Secondary	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.	Up to 60 days