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Clinical Trials/NCT02032550
NCT02032550
Completed
Not Applicable

Treatment Preference and Patient Centered Prostate Cancer Care

University of Pennsylvania3 sites in 1 country743 target enrollmentJune 2013
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University of Pennsylvania
Enrollment
743
Locations
3
Primary Endpoint
Change in Satisfaction With Care
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 26, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Satisfaction With Care

Time Frame: baseline, 3, 6, 12 and 24 months

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.

Secondary Outcomes

  • Depression(baseline, 3, 6, 12, and 24 months)
  • Generic Health Related Quality of Life (HRQoL)(baseline to 24 month)
  • Anxiety(baseline, 3, 6, 12, and 24 months)
  • Urinary Symptoms(baseline, 3, 6, 12, and 24 months)
  • Prostate Specific Health Related Quality of Life (HRQoL)(Baseline to 24 month)
  • Treatment Choice(6 months)
  • Satisfaction With Decision(baseline, 3, 6, 12, and 24 months)

Study Sites (3)

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