Decision Aids to Improve Knowledge in Patients With Prostate Cancer

Mayo Clinic103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

103

Conditions

Prostate Cancer

Interventions

Internet-Based InterventionOTHER

Receive "Knowing your Options" decision aid

Internet-Based InterventionOTHER

Receive "Prostate Choice" decision aid

Best PracticeOTHER

Undergo usual care

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Decisional Quality as Measured by Decisional Regret Scale

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).

Time frame: 12 months

Quality of Life Assessed by Questionnaire

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.

Time frame: 12 months

Utilization as Determined by Chart Review

Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms.

Data from ClinicalTrials.gov

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