Decision Aids to Improve Knowledge in Patients With Prostate Cancer

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Knowledge Assessed by Prostate Cancer Treatment Questionnaire	12 months	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

Secondary Outcome Measures

Name	Time	Method
Utilization as Determined by Chart Review	12 months	Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms.
Decisional Quality as Measured by Decisional Regret Scale	12 months	The Decisional Regret Scale is a short, 5-item scale measuring "distress or remorse after a (health care) decision." The instrument has been validated in other decision aid studies. Questions are answered on a 5-point agreement scale. A score of 0 means no decisional regret and 5 is the maximum level of regret. The continuous scores were then grouped into two categories, 0 (no regret) and 1+ (at least some regret).
Quality of Life Assessed by Questionnaire	12 months	The Expanded Prostate Cancer Index Composit (EPIC-26) measures health-related quality of life and returns summary scores for urinary, bowel, sexual, and hormonal domains with high test-retest reliability and internal consistency. Scores will be converted into continuous summary scores using standard algorithms. For the EPIC-26 questionnaire, scores were transformed into 0 to 100 scales, with a score of 0 represented the worst possible health-related quality of life and a score of 100 representing the most favorable health-related quality of life. The questionnaire will be administered once; 12 months after the patient's initial consultation.

Locations (5): Alaska Native Tribal Health Consortium
🇺🇸
Anchorage, Alaska, United States
Mayo Clinic
🇺🇸
Scottsdale, Arizona, United States
University Hospitals Case Medical Center
🇺🇸
Cleveland, Ohio, United States
Metrohealth Medical Center Urology Institute
🇺🇸
Cleveland, Ohio, United States
Regional Health
🇺🇸
Rapid City, South Dakota, United States
Alaska Native Tribal Health Consortium
🇺🇸Anchorage, Alaska, United States