Comparison of Explicit, Implicit and no Values Clarification Decision Aids for Men Considering Prostate Cancer Screening

NCT ID: NCT03988673

Last Updated: 2019-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-09-30

Brief Summary

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The investigators aim at comparing the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM. This study will add to the body of evidence on the role of decision aids to support health preference-sensitive choices and provide further insight on the impact of different methods for eliciting people's values embedded within a decision aid.

Detailed Description

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PSA test to screen for prostate cancer is considered a preference sensitive decision, meaning it does not only depend on what is best from a medical point of view, but also on patient values. Decision aids are evidence-based tools which showed to help people feel clearer about their values, therefore it has been advocated that decision aids should contain a specific values clarification method (VCM). VCM may be either implicit or explicit but the evidence concerning the best method is scarce. We aim at comparing the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel three group (1:1:1): (i) decision aid with information only (Control), (ii) decision aid with information plus an implicit VCM, (iii) decision aid with information plus an explicit VCM.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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decision aid with information only (control)

decision aid with information only, without values clarification method (VCM)

Group Type NO_INTERVENTION

No interventions assigned to this group

decision aid with implicit VCM

decision aid with information plus an implicit VCM

Group Type ACTIVE_COMPARATOR

Decision aid with implicit values clarification method (booklet or website)

Intervention Type OTHER

The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a grid where statements about the subject will be presented (decision aid with implicit VCM).

decision aid with explicit VCM

decision aid with information plus an explicit VCM

Group Type ACTIVE_COMPARATOR

Decision aid with explicit values clarification method (booklet or website)

Intervention Type OTHER

The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a a grid where statements about the subject will be presented and men should indicate what statements they identify with (decision aid with explicit VCM).

Interventions

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Decision aid with implicit values clarification method (booklet or website)

The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a grid where statements about the subject will be presented (decision aid with implicit VCM).

Intervention Type OTHER

Decision aid with explicit values clarification method (booklet or website)

The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a a grid where statements about the subject will be presented and men should indicate what statements they identify with (decision aid with explicit VCM).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult men (50 - 69 years);
* men with average risk for prostate cancer;
* willing and able to provide written informed consent.

Exclusion Criteria

* unable to understand written Portuguese.
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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NOVA Medical School

OTHER

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sofia Baptista, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Central Contacts

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Sofia Baptista, MD

Role: CONTACT

00351910357362

António Soares, PhD

Role: CONTACT

00351225513622

References

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Baptista S, Heleno B, Teixeira A, Taylor KL, Martins C. Comparison of explicit values clarification method (VCM), implicit VCM and no VCM decision aids for men considering prostate cancer screening: protocol of a randomized trial. BMC Med Inform Decis Mak. 2020 Apr 29;20(1):78. doi: 10.1186/s12911-020-1094-3.

Reference Type DERIVED
PMID: 32349746 (View on PubMed)

Other Identifiers

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DA-VCM

Identifier Type: -

Identifier Source: org_study_id

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