Comparison of Explicit, Implicit and no Values Clarification Decision Aids for Men Considering Prostate Cancer Screening
- Conditions
- Healthy Volunteers
- Interventions
- Other: Decision aid with implicit values clarification method (booklet or website)Other: Decision aid with explicit values clarification method (booklet or website)
- Registration Number
- NCT03988673
- Lead Sponsor
- Universidade do Porto
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 276
- adult men (50 - 69 years);
- men with average risk for prostate cancer;
- willing and able to provide written informed consent.
- unable to understand written Portuguese.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description decision aid with implicit VCM Decision aid with implicit values clarification method (booklet or website) decision aid with information plus an implicit VCM decision aid with explicit VCM Decision aid with explicit values clarification method (booklet or website) decision aid with information plus an explicit VCM
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method % 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
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.