Treatment Preference and Patient Centered Prostate Cancer Care

• ClinicalTrials.gov Identifier: NCT02032550
• Recruitment Status: Unknown
• First Posted: January 10, 2014
• Last Update Posted: May 2, 2017
• Sponsor: University of Pennsylvania
• 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

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

• 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

Arms and Interventions

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

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

Eligibility Criteria

• 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

Locations

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

• Principal Investigator: Ravishankar Jayadevappa, PhD; University of Pennsylvania

More Information

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

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.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02032550 History of Changes
• Other Study ID Numbers: PCC201
• First Posted: January 10, 2014
• 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:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases