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

Alliance for Clinical Trials in Oncology158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

158

Conditions

Stage II 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

Quality-of-Life AssessmentOTHER

Ancillary studies

Questionnaire AdministrationOTHER

Ancillary studies

Survey AdministrationOTHER

Ancillary studies

Laboratory Biomarker AnalysisOTHER

Correlative studies

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 (28)

Kaiser Permanente-Bellflower

Bellflower, California, United States

Kaiser Permanente-Cadillac

Los Angeles, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Augusta University Medical Center

Augusta, Georgia, United States

Tripler Army Medical Center

Honolulu, Hawaii, 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 percentage of total number correct. With 100%(12 out of 12 item average) being the best possible outcome and 0%(0 out of 12 item average) the worst possible outcome

Time frame: 12 months

Secondary Outcomes

Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret

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 median scores for each cohort were grouped into two categories, 0(no regret) and 1+(at least some regret).

Time frame: 12 months

Clinical Time Required

Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

Time frame: 12 months

Quality of Life Assessed by Questionnaire

The Expanded Prostate Cancer Index Composite(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 representing 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 received. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

Time frame: 12 months