Treatment Preference and Patient Centered Prostate Cancer Care

Prostate Cancer Clinical Trial

Official title:

Treatment Preference and Patient Centered Prostate Cancer Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032550
• Other study ID #: PCC201
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: January 26, 2018

Study information

• Verified date: July 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: January 26, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Philadelphia Veteran's Affairs Medical Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Corporal Michael J. Crescenz VA Medical Center, Fox Chase Cancer Center, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preference for Participation in Treatment Decision	The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.	baseline, 3, 6, 12, and 24 months
Other	Decision Conflict	The Decision Conflict Scale (DCS) will be used to measure decision conflict.	12 and 24 months
Other	Physician Trust	The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust	baseline
Primary	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.	baseline, 3, 6, 12 and 24 months
Secondary	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.	baseline to 24 month
Secondary	Anxiety	Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale	baseline, 3, 6, 12, and 24 months
Secondary	Urinary Symptoms	The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms	baseline, 3, 6, 12, and 24 months
Secondary	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.	6 months
Secondary	Depression	The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.	baseline, 3, 6, 12, and 24 months
Secondary	Satisfaction With Decision	The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.	baseline, 3, 6, 12, and 24 months
Secondary	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.	Baseline to 24 month