Treatment Preference and Patient Centered Prostate Cancer Care

NCT ID: NCT02032550

Last Updated: 2020-08-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

743 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-01-26

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Preference Based Decision Aid

The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.

Group Type EXPERIMENTAL

Preference Based Decision Aid

Intervention Type OTHER

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.

Usual Care

Participants randomized into this group will have usual care from their doctors without any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Corporal Michael J. Crescenz VA Medical Center

FED

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ravishankar Jayadevappa, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Philadelphia Veteran's Affairs Medical Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29587805 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PCC201

Identifier Type: -

Identifier Source: org_study_id

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