Healthy Volunteers
Conditions
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.
Interventions
OTHERDecision 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).
OTHERDecision 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).
Sponsors
NOVA Medical School
Georgetown University
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
MALE
Age
50 Years to 69 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived clarity of personal values | immediately after the intervention | 3-item subscale of the Decisional Conflict Scale. Items are given a score of 0 (strongly agree) to 4 (strongly disagree). Items are: a) summed; b) divided 3; and c) multiplied by 25. Scores range from 0 \[feels extremely clear about personal values\] to 100 \[feels extremely unclear about personal values\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict | immediately after the intervention | Decisional Conflict Scale (16-item). Items are given a score of 0 (strongly agree) to 4 (strongly disagree). Items are: a) summed; b) divided 16; and c) multiplied by 25. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]. |
| % of patients with preference to undergo PSA screening (screening intention; questionnaire) | before and immediately after the intervention | Intention to undergo prostate cancer screening with PSA: questionnaire - single question about intention to be screened with PSA, using a 5 point-Likert scale (ranging from strongly disagree to strongly agree; intention to undergo PSA screening will be considered positive if the respondent replies with agree or strongly agree). % of patients with preference to undergo PSA screening. |
| % of patients who underwent PSA screening (questionnaire) | 6 months after the intervention | Self-reported PSA screening. Questionnaire - single question. Men will report wether they have or have not underwent PSA screening after the intervention. % of patients who underwent PSA screening |
Contacts
Primary ContactSofia Baptista, MD
Backup ContactAntónio Soares, PhD
Outcome results
None listed