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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Preference Based Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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.
- 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.
- Anxiety [ Time Frame: 24 months ]Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale
- Urinary symptoms [ Time Frame: 24 months ]The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms
- 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.
- Depression [ Time Frame: 24 months ]The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.
- Satisfaction with medical care [ Time Frame: 24 months ]The Patient Satisfaction Questionnaire (PSQ-18) will be used to measure satisfaction with medical care.
- 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.
- Decision Conflict [ Time Frame: 24 months ]The Decision Conflict Scale (DCS) will be used to measure decision conflict.
- Physician Trust [ Time Frame: 24 months ]The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust
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
|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|
|Principal Investigator:||Ravishankar Jayadevappa, PhD||University of Pennsylvania|