Treatment Preference and Patient Centered Prostate Cancer Care

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Preference Based Decision Aid

• Registration Number: NCT02032550
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Primary Completion: 2018-01-26
• Study Completion: 2018-01-26
• Results First Submitted: 2018-03-23
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Results First Posted: 2020-08-04
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 743

Inclusion Criteria

1. Newly diagnosed with non-metastatic prostate cancer
2. Has not yet started radiation or surgery
3. Provide informed consent

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Exclusion Criteria

1. Distant, metastatic prostate cancer at diagnosis
2. Has already begun treatment for prostate cancer
3. Unable to communicate in English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preference Based Decision Aid	Preference Based Decision Aid	The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.

Primary Outcome Measures

Name	Time	Method
Change in Satisfaction With Care	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

Name	Time	Method
Depression	baseline, 3, 6, 12, and 24 months	The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.
Generic Health Related Quality of Life (HRQoL)	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.
Anxiety	baseline, 3, 6, 12, and 24 months	Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale
Urinary Symptoms	baseline, 3, 6, 12, and 24 months	The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms
Prostate Specific Health Related Quality of Life (HRQoL)	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.
Treatment Choice	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.
Satisfaction With Decision	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.

Trial Locations

Locations (3)

Philadelphia Veteran's Affairs Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States