Prostate Cancer Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

158

Study ID:

NCT03103321

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 25 Locations for this study

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Kaiser Permanente-Bellflower
Bellflower California, 90706, United States
Kaiser Permanente-Cadillac
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
Montefiore Medical Center-Einstein Campus
Bronx New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
Bronx New York, 10461, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
James J Peters VA Medical Center
Bronx New York, 10468, 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
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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

158

Study ID:

NCT03103321

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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