Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
NCT ID: NCT03103321
Last Updated: 2025-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
158 participants
INTERVENTIONAL
2017-10-02
2020-11-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm A ("Knowing your Options", "Prostate Choice")
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
Arm B ("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
Arm C ("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
Arm D (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
Interventions
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Internet-Based Intervention
Receive "Knowing your Options" decision aid
Internet-Based Intervention
Receive "Prostate Choice" decision aid
Best Practice
Undergo usual care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prostate-specific antigen (PSA) \< 50 ng/mL
* Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
* Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
* Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
* Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
* Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Locations
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Kaiser Permanente-Bellflower
Bellflower, California, United States
Kaiser Permanente-Cadillac
Los Angeles, California, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, United States
Augusta University Medical Center
Augusta, Georgia, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
James J Peters VA Medical Center
The Bronx, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Prisma Health Cancer Institute - Spartanburg
Spartanburg, South Carolina, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2017-00482
Identifier Type: REGISTRY
Identifier Source: secondary_id
A191402CD
Identifier Type: -
Identifier Source: org_study_id
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