Clinical trial NCT03988673: Comparison of Explicit, Implicit and no Values Clarification Decision Aids for Men Considering Prostate Cancer Screening
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: NOVA Medical School
name: Georgetown University
First posted: 2019-06-17
Enrollment: 276
Sex: MALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived clarity of personal values
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Decisional Conflict
timeFrame: immediately after the intervention
measure: % of patients with preference to undergo PSA screening (screening intention; questionnaire)
timeFrame: before and immediately after the intervention
measure: % of patients who underwent PSA screening (questionnaire)
timeFrame: 6 months after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Universidade do Porto
name: Sofia Baptista, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.