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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03988673
• Other study ID #: DA-VCM
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: September 2020

Study information

• Verified date: May 2019
• Source: Universidade do Porto
• Contact: Sofia Baptista, MD
• Phone: 00351910357362
• Email: sofiatbaptista[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 276
• Est. completion date: September 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Prostatic Neoplasms

Intervention

Other:
• 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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universidade do Porto	Georgetown University, NOVA Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived clarity of personal values	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].	immediately after the intervention
Secondary	Decisional Conflict	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].	immediately after the intervention
Secondary	% of patients with preference to undergo PSA screening (screening intention; questionnaire)	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.	before and immediately after the intervention
Secondary	% of patients who underwent PSA screening (questionnaire)	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	6 months after the intervention