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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-11595 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Conquer Cancer Foundation | OTHER |
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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.
PRIMARY OBJECTIVE:
1. To evaluate change in participant informed decision-making after provision of a consultation audio recording application.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consultation audio recording | Experimental | Instructions 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consultation audio recording app | Behavioral | Smartphone or tablet mobile application which allows for voice recording |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of approached patients' providers who agree to be recorded |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Kwon, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39569542 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Up to 28 days |
| 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 |
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |