Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

NCT03103321 | Completed Phase 3 Results DMC

• 2 other identifiers: A191402CDNCI-2017-00482
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 28

Brief Summary

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.

Conditions

Stage II Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage I Prostate Cancer; PSA Level Five to Ten; PSA Level Less Than Five; PSA Level Ten to Fifty

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret

  12 months

• Clinical Time Required

  12 months

• Quality of Life Assessed by Questionnaire

  12 months

• Utilization as Determined by Chart Review

  12 months

Study Arms (4)

Arm A ("Knowing your Options", "Prostate Choice")

EXPERIMENTAL

Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.

Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis

Arm B ("Knowing your Options")

EXPERIMENTAL

Patients receive "Knowing your Options" decision aid before their consultation visit.

Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis

Arm C ("Prostate Choice")

EXPERIMENTAL

Patients receive "Prostate Choice" decision aid during their consultation visit.

Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis

Arm D (usual care)

ACTIVE COMPARATOR

Patients undergo usual care.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis

Interventions

Internet-Based Intervention OTHER

Receive "Knowing your Options" decision aid

Arm A ("Knowing your Options", "Prostate Choice"); Arm B ("Knowing your Options")

Best Practice OTHER

Undergo usual care

Also known as: standard of care, standard therapy

Arm D (usual care)

Quality-of-Life Assessment OTHER

Ancillary studies

Arm A ("Knowing your Options", "Prostate Choice"); Arm B ("Knowing your Options"); Arm C ("Prostate Choice"); Arm D (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm A ("Knowing your Options", "Prostate Choice"); Arm B ("Knowing your Options"); Arm C ("Prostate Choice"); Arm D (usual care)

Survey Administration OTHER

Ancillary studies

Arm A ("Knowing your Options", "Prostate Choice"); Arm B ("Knowing your Options"); Arm C ("Prostate Choice"); Arm D (usual care)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A ("Knowing your Options", "Prostate Choice"); Arm B ("Knowing your Options"); Arm C ("Prostate Choice"); Arm D (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
• 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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (28)

Kaiser Permanente-Bellflower

Bellflower, California, 90706, United States

Location

Kaiser Permanente-Cadillac

Los Angeles, California, 90034, United States

Location

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Ochsner Health Center-Summa

Baton Rouge, Louisiana, 70809, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, 71103, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

Location

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Laurens

Clinton, South Carolina, 29325, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Prisma Health Cancer Institute - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• 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.

  PMID: 34890060 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.

  PMID: 30081846 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Jon C. Tilburt, MD
• Organization: Mayo Clinic

tilburt.jon@mayo.edu

5072661105

Study Officials

• tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: October 2, 2017
• Primary Completion: December 5, 2019
• Study Completion: November 25, 2020
• Last Updated: January 27, 2025
• Results First Posted: January 13, 2022

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data underlying the publication is available as of and will be available for the duration of the NCTN/NCORP Data Archive.
• Access Criteria: Instructions 1. Click to open the Protocol Section. 2. Click Edit next to the IPD Sharing Statement and select options for "Plan to Share IPD". 3. Click Edit next to the References section. 4. Under the References section, edit the following fields: 1. Links: https://nctn-data-archive.nci.nih.gov/ 2. Available IPD/Information: Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Locations

US (28)