Treatment Preference and Patient Centered Prostate Cancer Care

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Preference Based Decision Aid

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.

• Study Type: Interventional
• Enrollment (Actual): 743
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia Veteran's Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preference Based Decision Aid; 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; 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.
No Intervention: Usual Care; Participants randomized into this group will have usual care from their doctors without any intervention

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference for Participation in Treatment Decision	The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.	baseline, 3, 6, 12, and 24 months
Decision Conflict	The Decision Conflict Scale (DCS) will be used to measure decision conflict.	12 and 24 months
Physician Trust	The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust	baseline

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Patient-Centered Outcomes Research Institute; Fox Chase Cancer Center; Corporal Michael J. Crescenz VA Medical Center
• Investigators: Principal Investigator: Ravishankar Jayadevappa, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): January 26, 2018
• Study Completion (Actual): January 26, 2018

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Localized prostate cancer; Decision making; Patient preference; Patient centered outcomes; Treatment choice
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PCC201