Decision Aids to Improve Knowledge in Patients With Prostate Cancer
Status
Completed
Conditions
Prostate Cancer
Treatments
Other: Questionnaire Administration
Other: Best Practice
Other: Internet-Based Intervention
Other: Laboratory Biomarker Analysis
Other: Survey Administration
Other: Quality-of-Life Assessment
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
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.
Enrollment
103 patients
Sex
Male
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
103 participants in 3 patient groups
Arm A (Knowing Your Options)
Experimental group
Description:
Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit.
Treatment:
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other: Internet-Based Intervention
Other: Laboratory Biomarker Analysis
Other: Survey Administration
Other: Internet-Based Intervention
Arm B (Prostate Choice)
Experimental group
Description:
Patients receive "Prostate Choice" decision aid during their consultation visit.
Treatment:
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other: Internet-Based Intervention
Other: Laboratory Biomarker Analysis
Other: Survey Administration
Other: Internet-Based Intervention
Arm C (Usual Care)
Active Comparator group
Description:
Patients undergo usual care.
Treatment:
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other: Laboratory Biomarker Analysis
Other: Survey Administration
Other: Best Practice
Trial contacts and locations
5
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Data sourced from clinicaltrials.gov
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