Clinical trial NCT02032550: Treatment Preference and Patient Centered Prostate Cancer Care
Official title: Treatment Preference and Patient Centered Prostate Cancer Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Localized prostate cancer
Patient preference
Treatment choice
Decision making
Patient centered outcomes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Corporal Michael J. Crescenz VA Medical Center
name: Fox Chase Cancer Center
First posted: 2014-01-10
Enrollment: 743
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed with non-metastatic prostate cancer
2. Has not yet started radiation or surgery
3. Provide informed consent

Exclusion Criteria:

1. Distant, metastatic prostate cancer at diagnosis
2. Has already begun treatment for prostate cancer
3. Unable to communicate in English

Primary outcomes:
measure: Change in Satisfaction With Care
timeFrame: baseline, 3, 6, 12 and 24 months
Secondary outcomes:
measure: Generic Health Related Quality of Life (HRQoL)
timeFrame: baseline to 24 month
measure: Anxiety
timeFrame: baseline, 3, 6, 12, and 24 months
measure: Urinary Symptoms
timeFrame: baseline, 3, 6, 12, and 24 months
measure: Treatment Choice
timeFrame: 6 months
measure: Depression
timeFrame: baseline, 3, 6, 12, and 24 months
measure: Satisfaction With Decision
timeFrame: baseline, 3, 6, 12, and 24 months
measure: Prostate Specific Health Related Quality of Life (HRQoL)
timeFrame: Baseline to 24 month
Other outcomes:
measure: Preference for Participation in Treatment Decision
timeFrame: baseline, 3, 6, 12, and 24 months
measure: Decision Conflict
timeFrame: 12 and 24 months
measure: Physician Trust
timeFrame: baseline
Locations:
city: Philadelphia
country: United States
facility: Philadelphia Veteran's Affairs Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ravishankar Jayadevappa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chhatre S, Jefferson A, Cook R, Meeker CR, Kim JH, Hartz KM, Wong YN, Caruso A, Newman DK, Morales KH, Jayadevappa R. Patient-centered recruitment and retention for a randomized controlled study. Trials. 2018 Mar 27;19(1):205. doi: 10.1186/s13063-018-2578-7.