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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00482 | Registry Identifier | NCI Clinical Trial Reporting Program |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.
PRIMARY OBJECTIVES:
I. To test the comparative effectiveness of decision aids (DA's) on patient knowledge.
SECONDARY OBJECTIVES:
I. To test the impact of in-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.
II. To test the impact of out-of-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.
III. To test the impact of combined in-visit and out-of-visit DA's compared to both usual care and individual DAs on quality of life outcomes and treatment utilization.
IV. To test the comparative effectiveness of DA's on minority men's knowledge. V. To compare clinic time required to administer the DA's across arms.
OUTLINE: Patients are randomized into 1 of 4 arms.
ARM A: Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
ARM B: Patients receive "Knowing your Options" decision aid before their consultation visit.
ARM C: Patients receive "Prostate Choice" decision aid during their consultation visit.
ARM D: Patients undergo usual care.
After completion of study, patients are followed up at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A ("Knowing your Options", "Prostate Choice") | Experimental | Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit. |
|
| Arm B ("Knowing your Options") | Experimental | Patients receive "Knowing your Options" decision aid before their consultation visit. |
|
| Arm C ("Prostate Choice") | Experimental | Patients receive "Prostate Choice" decision aid during their consultation visit. |
|
| Arm D (usual care) | Active Comparator | Patients undergo usual care. |
|
| 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 percentage of total number correct. With 100%(12 out of 12 item average) being the best possible outcome and 0%(0 out of 12 item average) the worst possible outcome | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | 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 median scores for each cohort were 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 |
|---|---|---|
| tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente-Bellflower | Bellflower | California | 90706 | United States | ||
| Kaiser Permanente-Cadillac |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34890060 | Derived | Tilburt JC, Zahrieh D, Pacyna JE, Petereit DG, Kaur JS, Rapkin BD, Grubb RL 3rd, Chang GJ, Morris MJ, Kovac EZ, Babaian KN, Sloan JA, Basch EM, Peil ES, Dueck AC, Novotny PJ, Paskett ED, Buckner JC, Joyce DD, Montori VM, Frosch DL, Volk RJ, Kim SP. Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD). Cancer. 2022 Mar 15;128(6):1242-1251. doi: 10.1002/cncr.34062. Epub 2021 Dec 10. | |
| 30081846 |
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IPD that underlie results in the publication PubMed ID 34890060.
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The data underlying the publication is available as of and will be available for the duration of the NCTN/NCORP Data Archive.
Instructions
Click to open the Protocol Section.
Click Edit next to the IPD Sharing Statement and select options for "Plan to Share IPD".
Click Edit next to the References section.
Under the References section, edit the following fields:
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre- and During-consultation Decision Aids | Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit. Internet-Based Intervention: Receive "Knowing your Options" decision aid 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 |
| 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 | Nov 30, 2018 |
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| Internet-Based Intervention | Other | Receive "Prostate Choice" decision aid |
|
| Best Practice | Other | Undergo usual care |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Survey Administration | Other | Ancillary studies |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| 12 months |
| Clinical Time Required | Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups. | 12 months |
| Quality of Life Assessed by Questionnaire | The Expanded Prostate Cancer Index Composite(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 representing 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 received. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups. | 12 months |
| Los Angeles |
| California |
| 90034 |
| United States |
| Kaiser Permanente Oakland-Broadway | Oakland | California | 94611 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Ochsner Health Center-Summa | Baton Rouge | Louisiana | 70809 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Louisiana State University Health Sciences Center Shreveport | Shreveport | Louisiana | 71103 | United States |
| William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | United States |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center-Weiler Hospital | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| James J Peters VA Medical Center | The Bronx | New York | 10468 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health Cancer Institute - Laurens | Clinton | South Carolina | 29325 | United States |
| Prisma Health Cancer Institute - Easley | Easley | South Carolina | 29640 | United States |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | United States |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | United States |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | United States |
| Prisma Health Cancer Institute - Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| Derived |
| Pacyna JE, Kim S, Yost K, Sedlacek H, Petereit D, Kaur J, Rapkin B, Grubb R, Paskett E, Chang GJ, Sloan J, Basch E, Major B, Novotny P, Taylor J, Buckner J, Parsons JK, Morris M, Tilburt JC. The comparative effectiveness of decision aids in diverse populations with early stage prostate cancer: a study protocol for a cluster-randomized controlled trial in the NCI Community Oncology Research Program (NCORP), Alliance A191402CD. BMC Cancer. 2018 Aug 6;18(1):788. doi: 10.1186/s12885-018-4672-3. |
| FG001 | Pre-consultation Decision Aids Only | 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 |
| FG002 | During-consultation Decision Aids Only | 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 |
| FG003 | 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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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre- and During-consultation Decision Aids | Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit. Internet-Based Intervention: Receive "Knowing your Options" decision aid 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 |
| BG001 | Pre-consultation Decision Aids Only | 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 |
| BG002 | During-consultation Decision Aids Only | 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 |
| BG003 | 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 |
| BG004 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| 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 percentage of total number correct. With 100%(12 out of 12 item average) being the best possible outcome and 0%(0 out of 12 item average) the worst possible outcome | Posted | Mean | Standard Deviation | percentage of items correct | 12 months |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | 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 median scores for each cohort were grouped into two categories, 0(no regret) and 1+(at least some regret). | Posted | Count of Participants | Participants | 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Time Required | Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups. | Posted | Median | Full Range | Minutes | 12 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life Assessed by Questionnaire | The Expanded Prostate Cancer Index Composite(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 representing 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. | Posted | Median | 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 received. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups. | Only includes eligible patients that reached 12 months. | Posted | Count of Participants | Participants | 12 months |
|
12 months
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 | Pre- and During-consultation Decision Aids | Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit. Internet-Based Intervention: Receive "Knowing your Options" decision aid 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 | 24 | 0 | 0 | 0 | 0 |
| EG001 | Pre-consultation Decision Aids Only | 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 | 1 | 38 | 0 | 0 | 0 | 0 |
| EG002 | During-consultation Decision Aids Only | 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 | 1 | 43 | 0 | 0 | 0 | 0 |
| EG003 | 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 | 50 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon C. Tilburt, MD | Mayo Clinic | 5072661105 | tilburt.jon@mayo.edu |
| May 4, 2021 |
| 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 |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| OG002 | During-consultation Decision Aids Only | 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 |
| OG003 | 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 |
|
|
| During-consultation Decision Aids Only |
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 |
| OG003 | 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 | During-consultation Decision Aids Only | 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 |
| OG003 | 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 | During-consultation Decision Aids Only | 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 |
| OG003 | 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 |
|
|