University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT05127850
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.
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Notify Me18 year and older
Male
Interventional
Not applicable
San Francisco, California, 94143, United States
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
EXPLORATORY OBJECTIVES:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
(provider participants):
Exclusion criteria
Smartphone or tablet mobile application which allows for voice recording
Other names: Voice Recording app, Mobile voice recording app, Smartphone voice recording app, Tablet voice recording app
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.
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).
Time frame: 1 day
The proportion of participants who consented to the study from the total number of participants contacted will be reported.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Up to 60 days
Auto-generated transcript accuracy will be measured by comparing the transcript to research staff transcription of the recording.
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.
University of California, San Francisco
Other
Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer
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