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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

Conditions
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Stage II Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage I Prostate Cancer, PSA Level Five to Ten, PSA Level Less Than Five, PSA Level Ten to Fifty

Intervention / Treatment
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* Other: Internet-Based Intervention
* Other: Internet-Based Intervention
* Other: Best Practice
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Survey Administration
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (Knowing your Options, Prostate Choice)<br>Patients receive decision aids Knowing your Options before and Prostate Choice during their consultation visit. | Other: Internet-Based Intervention<br>* Receive Knowing your Options decision aid<br>Other: Internet-Based Intervention<br>* Receive Prostate Choice decision aid<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|
| Experimental: Arm B (Knowing your Options)<br>Patients receive Knowing your Options decision aid before their consultation visit. | Other: Internet-Based Intervention<br>* Receive Knowing your Options decision aid<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|
| Experimental: Arm C (Prostate Choice)<br>Patients receive Prostate Choice decision aid during their consultation visit. | Other: Internet-Based Intervention<br>* Receive Prostate Choice decision aid<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|
| Active Comparator: Arm D (usual care)<br>Patients undergo usual care. | Other: Best Practice<br>* Undergo usual care<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 12 months |