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

Universidade do Porto

Status: Unknown

Conditions: Healthy Volunteers

Treatments: Other: Decision aid with implicit values clarification method (booklet or website); Other: Decision aid with explicit values clarification method (booklet or website)

Study type: Interventional

Funder types: Other

Identifiers

NCT03988673

DA-VCM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 276 estimated patients

Sex: Male

Ages: 50 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 3 patient groups

decision aid with information only (control)

No Intervention group

Description:

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

decision aid with implicit VCM

Active Comparator group

Description:

decision aid with information plus an implicit VCM

Treatment:

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

decision aid with explicit VCM

Active Comparator group

Description:

decision aid with information plus an explicit VCM

Treatment:

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