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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD008934-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Knowing Your Options) | Experimental | Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit. |
|
| Arm B (Prostate Choice) | Experimental | Patients receive "Prostate Choice" decision aid during their consultation visit. |
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| Arm C (Usual Care) | Active Comparator | Patients undergo usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Receive "Knowing your Options" decision aid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge Assessed by Prostate Cancer Treatment Questionnaire | The primary outcome, knowledge, will be assessed by a standardized questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after the clinical consultation while the patient is still at the study site. The number correct from this 12-item measure will be reduced to a proportion of total number correct. With 1.0 (12 out of 12 item average) being the best possible outcome and 0.0 (0 out of 12 item average) the worst possible outcome | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decisional Quality as Measured by Decisional Regret Scale | The Decisional Regret Scale is a short, 5-item scale measuring "distress or remorse after a (health care) decision." The instrument has been validated in other decision aid studies. Questions are answered on a 5-point agreement scale. A score of 0 means no decisional regret and 5 is the maximum level of regret. The continuous scores were then grouped into two categories, 0 (no regret) and 1+ (at least some regret). |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon C. Tilburt, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Native Tribal Health Consortium | Anchorage | Alaska | 99508 | United States | ||
| Mayo Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Knowing Your Options) | Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit. Internet-Based Intervention: Receive "Knowing your Options" decision aid Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2021 |
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| Internet-Based Intervention | Other | Receive "Prostate Choice" decision aid |
|
| Best Practice | Other | Undergo usual care |
|
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| 12 months |
| Quality of Life Assessed by Questionnaire | The Expanded Prostate Cancer Index Composit (EPIC-26) measures health-related quality of life and returns summary scores for urinary, bowel, sexual, and hormonal domains with high test-retest reliability and internal consistency. Scores will be converted into continuous summary scores using standard algorithms. For the EPIC-26 questionnaire, scores were transformed into 0 to 100 scales, with a score of 0 represented the worst possible health-related quality of life and a score of 100 representing the most favorable health-related quality of life. The questionnaire will be administered once; 12 months after the patient's initial consultation. | 12 months |
| Utilization as Determined by Chart Review | Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms. | 12 months |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Metrohealth Medical Center Urology Institute | Cleveland | Ohio | 44109 | United States |
| Regional Health | Rapid City | South Dakota | 57701 | United States |
| FG001 | Arm B (Prostate Choice) | Patients receive "Prostate Choice" decision aid during their consultation visit. Internet-Based Intervention: Receive "Prostate Choice" decision aid Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| FG002 | Arm C (Usual Care) | Patients undergo usual care. Best Practice: Undergo usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Knowing Your Options) | Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit. Internet-Based Intervention: Receive "Knowing your Options" decision aid Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| BG001 | Arm B (Prostate Choice) | Patients receive "Prostate Choice" decision aid during their consultation visit. Internet-Based Intervention: Receive "Prostate Choice" decision aid Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| BG002 | Arm C (Usual Care) | Patients undergo usual care. Best Practice: Undergo usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Treatment Preferred | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knowledge Assessed by Prostate Cancer Treatment Questionnaire | The primary outcome, knowledge, will be assessed by a standardized questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after the clinical consultation while the patient is still at the study site. The number correct from this 12-item measure will be reduced to a proportion of total number correct. With 1.0 (12 out of 12 item average) being the best possible outcome and 0.0 (0 out of 12 item average) the worst possible outcome | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
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| Secondary | Decisional Quality as Measured by Decisional Regret Scale | The Decisional Regret Scale is a short, 5-item scale measuring "distress or remorse after a (health care) decision." The instrument has been validated in other decision aid studies. Questions are answered on a 5-point agreement scale. A score of 0 means no decisional regret and 5 is the maximum level of regret. The continuous scores were then grouped into two categories, 0 (no regret) and 1+ (at least some regret). | Secondary outcomes were to be based on data collected at 12 months. Two of our sites (enrolling >50% of study participants) experienced staff turnover and/or loss of contact with participants. As a result, we lost our ability and opportunity to maintain contact with nearly all participants at both sites and were unable to collect secondary outcome data at 12 months. Results reported here reflect the data we were able to collect. | Posted | Count of Participants | Participants | 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life Assessed by Questionnaire | The Expanded Prostate Cancer Index Composit (EPIC-26) measures health-related quality of life and returns summary scores for urinary, bowel, sexual, and hormonal domains with high test-retest reliability and internal consistency. Scores will be converted into continuous summary scores using standard algorithms. For the EPIC-26 questionnaire, scores were transformed into 0 to 100 scales, with a score of 0 represented the worst possible health-related quality of life and a score of 100 representing the most favorable health-related quality of life. The questionnaire will be administered once; 12 months after the patient's initial consultation. | Secondary outcomes were to be based on data collected at 12 months. Two of our sites (enrolling >50% of study participants) experienced staff turnover and/or loss of contact with participants. As a result, we lost our ability and opportunity to maintain contact with nearly all participants at both sites and were unable to collect secondary outcome data at 12 months. Results reported here reflect the data we were able to collect. | Posted | Mean | Full Range | score on a scale | 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Utilization as Determined by Chart Review | Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms. | Secondary outcomes were to be based on data collected at 12 months. Treatment choice could be ascertained immediately upon patient treatment selection. Two of our sites (enrolling >50% of study participants) experienced staff turnover and/or loss of contact with participants. As a result, we lost our ability and opportunity to maintain contact with several participants and were unable to collect treatment choice for all participants. Results reported reflect the data we were able to collect. | Posted | Count of Participants | Participants | 12 months |
|
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This study did not collect adverse events.
We do not anticipate any additional adverse events related to participation in this study beyond usual care. If patients experience any emotional discomfort when completing the questionnaires, they may choose not to complete them and/or speak with the site staff. Patients experiencing any physical or psychological complications related to their standard of care treatment should discuss this with their treating physician.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Knowing Your Options) | Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit. Internet-Based Intervention: Receive "Knowing your Options" decision aid Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Arm B (Prostate Choice) | Patients receive "Prostate Choice" decision aid during their consultation visit. Internet-Based Intervention: Receive "Prostate Choice" decision aid Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Arm C (Usual Care) | Patients undergo usual care. Best Practice: Undergo usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jon C. Tilburt, MD, MPH | Mayo Clinic | 480-301-3401 | tilburt.jon@mayo.edu |
| Apr 26, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Radiation |
|
| Active surveillance |
|
| Unsure |
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| Missing |
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| OG002 | Arm C (Usual Care) | Patients undergo usual care. Best Practice: Undergo usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
|
|
| OG001 |
| Arm B (Prostate Choice) |
Patients receive "Prostate Choice" decision aid during their consultation visit. Internet-Based Intervention: Receive "Prostate Choice" decision aid Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| OG002 | Arm C (Usual Care) | Patients undergo usual care. Best Practice: Undergo usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
|
|
| OG002 | Arm C (Usual Care) | Patients undergo usual care. Best Practice: Undergo usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
|
|