Decision Aids to Improve Knowledge in Patients With Prostate Cancer

NCT03182998 | Completed Results DMC

• 2 other identifiers: 16-010459R01MD008934-05
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Prostate Cancer

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 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

Secondary Outcomes (3)

• Decisional Quality as Measured by Decisional Regret Scale

  12 months

• Quality of Life Assessed by Questionnaire

  12 months

• Utilization as Determined by Chart Review

  12 months

Study Arms (3)

Arm A (Knowing Your Options)

EXPERIMENTAL

Arm A ("Knowing your Options") 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 B (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 C (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)

Best Practice OTHER

Undergo usual care

Also known as: best practice, Best Practice, standard of care, standard therapy

Arm C (Usual Care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment, Quality-of-Life Assessment

Arm A (Knowing Your Options); Arm B (Prostate Choice); Arm C (Usual Care)

Questionnaire Administration OTHER

Ancillary studies

Arm A (Knowing Your Options); Arm B (Prostate Choice); Arm C (Usual Care)

Survey Administration OTHER

Ancillary studies

Arm A (Knowing Your Options); Arm B (Prostate Choice); Arm C (Usual Care)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (Knowing Your Options); Arm B (Prostate Choice); Arm C (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

• Mayo Clinic: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (5)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99508, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Metrohealth Medical Center Urology Institute

Cleveland, Ohio, 44109, United States

Location

Regional Health

Rapid City, South Dakota, 57701, United States

Location

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: Dr. Jon C. Tilburt, MD, MPH
• Organization: Mayo Clinic

tilburt.jon@mayo.edu

480-301-3401

Study Officials

• Jon C. Tilburt, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 9, 2017
• Study Start: July 14, 2017
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)