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Treatment Preference and Patient Centered Prostate Cancer Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032550
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Corporal Michael J. Crescenz VA Medical Center
Fox Chase Cancer Center
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Preference Based Decision Aid Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 743 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Treatment Preference and Patient Centered Prostate Cancer Care
Study Start Date : June 2013
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Generic Health Related Quality of Life (HRQoL) [ Time Frame: baseline to 24 month ]
    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.

  2. Anxiety [ Time Frame: baseline, 3, 6, 12, and 24 months ]
    Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale

  3. Urinary Symptoms [ Time Frame: baseline, 3, 6, 12, and 24 months ]
    The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms

  4. Treatment Choice [ Time Frame: 6 months ]
    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.

  5. Depression [ Time Frame: baseline, 3, 6, 12, and 24 months ]
    The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.

  6. Satisfaction With Decision [ Time Frame: baseline, 3, 6, 12, and 24 months ]
    The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.

  7. Prostate Specific Health Related Quality of Life (HRQoL) [ Time Frame: Baseline to 24 month ]
    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.


Other Outcome Measures:
  1. Preference for Participation in Treatment Decision [ Time Frame: baseline, 3, 6, 12, and 24 months ]
    The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.

  2. Decision Conflict [ Time Frame: 12 and 24 months ]
    The Decision Conflict Scale (DCS) will be used to measure decision conflict.

  3. Physician Trust [ Time Frame: baseline ]
    The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032550


Locations
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United States, Pennsylvania
Philadelphia Veteran's Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
University of Pennsylvania
Patient-Centered Outcomes Research Institute
Corporal Michael J. Crescenz VA Medical Center
Fox Chase Cancer Center
Investigators
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Principal Investigator: Ravishankar Jayadevappa, PhD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol and Statistical Analysis Plan  [PDF] July 30, 2014

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02032550    
Other Study ID Numbers: PCC201
First Posted: January 10, 2014    Key Record Dates
Results First Posted: August 4, 2020
Last Update Posted: August 4, 2020
Last Verified: July 2020
Keywords provided by University of Pennsylvania:
Localized prostate cancer
Patient preference
Treatment choice
Decision making
Patient centered outcomes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases