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



Status:Recruiting
Conditions:Prostate Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:July 14, 2017
End Date:July 2020
Contact:Jon Tilburt, MD
Email:tilburt.jon@mayo.edu
Phone:855-776-0015

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Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

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.

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
We found this trial at
28
sites
New Orleans, Louisiana 70121
Principal Investigator: Daniel J. Canter
Phone: 504-703-8712
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Michael S. Davis
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Principal Investigator: Asit K. Paul
Phone: 773-702-9171
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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Richmond, VA
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Augusta, Georgia 30912
Principal Investigator: Sharad A. Ghamande
Phone: 706-721-2388
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Baton Rouge, Louisiana 70809
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Bellflower, California 90706
Principal Investigator: Han A. Koh
Phone: 800-398-3996
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Bronx, New York 10461
Principal Investigator: Evan Kovac
Phone: 718-379-6866
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Bronx, New York 10468
Principal Investigator: Christopher B. Anderson
Phone: 718-584-9000
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Bronx, NY
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Chanita Hughes-Halbert
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
Principal Investigator: Thomas E. Lad
Phone: 312-864-5204
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Greenville, South Carolina 29605
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Greenville, South Carolina 29605
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Greenville, South Carolina 29615
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701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
Principal Investigator: Jeffrey K. Giguere
Phone: 864-679-3966
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
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1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
Principal Investigator: John E. Musser
Phone: 808-433-6336
Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
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450 Lakeville Road
Lake Success, New York 11042
Principal Investigator: Michael A. Diefenbach
Phone: 516-734-8896
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Los Angeles, California 90034
Principal Investigator: Han A. Koh
Phone: 800-398-3996
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New York, New York 10032
Principal Investigator: Guarionex J. DeCastro
Phone: 212-305-6361
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Oakland, California 94611
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
Principal Investigator: Sugandh D. Shetty
Phone: 248-551-7695
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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Shreveport, Louisiana 71103
Principal Investigator: Kara N. Babaian
Phone: 318-813-1422
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Spartanburg, South Carolina 29307
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