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Treatment Preference and Patient Centered Prostate Cancer Care

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ClinicalTrials.gov Identifier: NCT02032550
Recruitment Status : Unknown
Verified April 2017 by University of Pennsylvania.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2014
Last Update Posted : May 2, 2017
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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. Satisfaction with treatment choice [ Time Frame: 24 months ]
    The investigators will measure Satisfaction with Decision (SWD): The SWD scale measures satisfaction with healthcare decisions and Regret scale: Regret represents the unsettling feeling of having made a poor choice of treatment, persistent doubt, and a wish to change one's mind at 3, 6, 12, and 24 months.


Secondary Outcome Measures :
  1. Generic and Prostate Specific Health Related Quality of Life [ Time Frame: 24 months ]
    Generic HRQoL data will be obtained using the Medical Outcome Study Short Form (SF-36) a multi-item scale that assesses eight health domains. Prostate specific health related quality of life data will be obtain using Expanded Prostate Cancer Index (EPIC). The EPIC is a 50-item expanded edition of the 20-item UCLA Prostate Cancer Index (PCI) and complements other instruments by measuring a broad spectrum of urinary, bowel, sexual and hormonal symptoms. Measurements will be done at baseline, 3 month, 6 month, 12 month and 24 month of followup.

  2. Cancer Recurrence and complications [ Time Frame: 24 months ]
    The investigators will obtain PSA data at baseline, prior to treatment, and post treatment. All cancer recurrence data will be obtained through medical chart review. The investigators will identify complications that occur during either index or subsequent hospital admissions within 60 days of treatment.

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

  4. Urinary symptoms [ Time Frame: 24 months ]
    The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms

  5. 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.

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

  7. Satisfaction with medical care [ Time Frame: 24 months ]
    The Patient Satisfaction Questionnaire (PSQ-18) will be used to measure satisfaction with medical care.


Other Outcome Measures:
  1. Preference for participation in treatment decision [ Time Frame: 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: 24 months ]
    The Decision Conflict Scale (DCS) will be used to measure decision conflict.

  3. Physician Trust [ Time Frame: 24 months ]
    The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust



Information from the National Library of Medicine

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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

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

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     History of Changes
Other Study ID Numbers: PCC201
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

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
Genital Diseases, Male
Prostatic Diseases