Treatment Preference and Patient Centered Prostate Cancer Care
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preference Based Decision Aid
Sponsored by

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Localized prostate cancer, Patient preference, Treatment choice, Decision making, Patient centered outcomes
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
Sites / Locations
- Philadelphia Veteran's Affairs Medical Center
- University of Pennsylvania Health System
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Preference Based Decision Aid
Usual Care
Arm Description
The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.
Participants randomized into this group will have usual care from their doctors without any intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Anxiety
Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale
Urinary Symptoms
The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms
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.
Depression
The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.
Satisfaction With Decision
The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 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.
Full Information
NCT ID
NCT02032550
First Posted
December 23, 2013
Last Updated
July 17, 2020
Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute, Corporal Michael J. Crescenz VA Medical Center, Fox Chase Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02032550
Brief Title
Treatment Preference and Patient Centered Prostate Cancer Care
Official Title
Treatment Preference and Patient Centered Prostate Cancer Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
January 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute, Corporal Michael J. Crescenz VA Medical Center, Fox Chase Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Localized prostate cancer, Patient preference, Treatment choice, Decision making, Patient centered outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
743 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preference Based Decision Aid
Arm Type
Experimental
Arm Description
The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized into this group will have usual care from their doctors without any intervention
Intervention Type
Other
Intervention Name(s)
Preference Based Decision Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Satisfaction With Care
Description
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.
Time Frame
baseline, 3, 6, 12 and 24 months
Secondary Outcome Measure Information:
Title
Generic Health Related Quality of Life (HRQoL)
Description
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.
Time Frame
baseline to 24 month
Title
Anxiety
Description
Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale
Time Frame
baseline, 3, 6, 12, and 24 months
Title
Urinary Symptoms
Description
The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms
Time Frame
baseline, 3, 6, 12, and 24 months
Title
Treatment Choice
Description
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.
Time Frame
6 months
Title
Depression
Description
The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.
Time Frame
baseline, 3, 6, 12, and 24 months
Title
Satisfaction With Decision
Description
The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.
Time Frame
baseline, 3, 6, 12, and 24 months
Title
Prostate Specific Health Related Quality of Life (HRQoL)
Description
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.
Time Frame
Baseline to 24 month
Other Pre-specified Outcome Measures:
Title
Preference for Participation in Treatment Decision
Description
The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.
Time Frame
baseline, 3, 6, 12, and 24 months
Title
Decision Conflict
Description
The Decision Conflict Scale (DCS) will be used to measure decision conflict.
Time Frame
12 and 24 months
Title
Physician Trust
Description
The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust
Time Frame
baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravishankar Jayadevappa, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia Veteran's Affairs Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29587805
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.
Results Reference
derived
Learn more about this trial
Treatment Preference and Patient Centered Prostate Cancer Care
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