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

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Decision aid with implicit values clarification method (booklet or website); Other: Decision aid with explicit values clarification method (booklet or website)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: decision aid with information only (control); decision aid with information only, without values clarification method (VCM)
Active Comparator: decision aid with implicit VCM; decision aid with information plus an implicit VCM	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).
Active Comparator: decision aid with explicit VCM; decision aid with information plus an explicit VCM	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
% 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
% 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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Georgetown University; NOVA Medical School
• Investigators: Principal Investigator: Sofia Baptista, MD, Universidade do Porto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: DA-VCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be made available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No