Treatment Preference and Patient Centered Prostate Cancer Care

Study Overview
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Brief Summary
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The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.

Detailed Description
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The objective is to test the comparative effectiveness of a conjoint analysis decision aid intervention compared to usual care. The investigators will identify preferred attributes of prostate cancer treatments that will help in designing a conjoint analysis decision aid to help patients weigh treatment attributes. The investigators will employ values markers to represent clusters of values for particular aspects of treatments that are valued most by individual patients. The investigators will test if the concordance between values markers and treatment received is predictive of objective outcomes and subjective outcomes. The study hypothesis is that conjoint task may help in treatment choice and prostate cancer patients whose treatment is more concordant with their values markers will have improved outcomes.

Official Title
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Treatment Preference and Patient Centered Prostate Cancer Care

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Preference Based Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed with non-metastatic prostate cancer Has not yet started radiation or surgery Provide informed consent Exclusion Criteria: Distant, metastatic prostate cancer at diagnosis Has already begun treatment for prostate cancer Unable to communicate in English

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preference Based Decision Aid<br>The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment. | Other: Preference Based Decision Aid<br>* The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.<br>|
| No Intervention: Usual Care<br>Participants randomized into this group will have usual care from their doctors without any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Satisfaction With Care | The investigators will measure Satisfaction with Care (PSQ-18). : The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months. Higher score indicates better satisfaction with care. Positive change indicates improvement in satisfaction with care. | baseline, 3, 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generic Health Related Quality of Life (HRQoL) | Generic HRQoL data is obtained from Medical Outcome Study Short Form (SF-36) that assesses 8 health domains. Scores on each domain range from 0 to 100, higher scores indicating better generic HRQoL. Change in SF-36 domain scores between baseline to 24 month will be calculated as score at 24 month-score minus score at baseline. Positive change value indicates improvement in HRQoL from baseline to 24 month. | baseline to 24 month | 
| Anxiety | Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale | baseline, 3, 6, 12, and 24 months | 
| Urinary Symptoms | The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms | baseline, 3, 6, 12, and 24 months | 
| Treatment Choice | The investigators will obtain data on primary and secondary treatments received, such as active surveillance, radical prostatectomy (RP), robotic-assisted laparoscopic prostatectomy (RALP), external beam radiation therapy (EBRT), brachytherapy (BT) or proton therapy (PT) via self report and verified from medical chart review. | 6 months | 
| Depression | The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression. | baseline, 3, 6, 12, and 24 months | 
| Satisfaction With Decision | The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months. | baseline, 3, 6, 12, and 24 months | 
| Prostate Specific Health Related Quality of Life (HRQoL) | Prostate specific HRQoL data is obtained from Expanded Prostate Cancer Index (EPIC), and measures four broad domains of urinary, bowel, sexual and hormonal symptoms. Scores on each sub-scale range from 0 to 100, with higher scores indicating better prostate cancer HRQoL. Proportion of participants returning to baseline scores will be calculated by comparing scores at baseline and at 24 month. Higher proportion indicates higher number of participants recovering baseline function by 24 month. | Baseline to 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Localized prostate cancer, Patient preference, Treatment choice, Decision making, Patient centered outcomes