NCT03988673

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable healthy-volunteers

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 17, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

June 3, 2019

Last Update Submit

June 14, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Decisional Conflict

    immediately after the intervention

  • % of patients with preference to undergo PSA screening (screening intention; questionnaire)

    before and immediately after the intervention

  • % of patients who underwent PSA screening (questionnaire)

    6 months after the intervention

Study Arms (3)

decision aid with information only (control)

NO INTERVENTION

decision aid with information only, without values clarification method (VCM)

decision aid with implicit VCM

ACTIVE COMPARATOR

decision aid with information plus an implicit VCM

Other: Decision aid with implicit values clarification method (booklet or website)

decision aid with explicit VCM

ACTIVE COMPARATOR

decision aid with information plus an explicit VCM

Other: Decision aid with explicit values clarification method (booklet or website)

Interventions

Decision aid with implicit values clarification method (booklet or website)OTHER

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 implicit VCM
Decision aid with explicit values clarification method (booklet or website)OTHER

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).

decision aid with explicit VCM

Eligibility Criteria

Age50 Years - 69 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsthe intervention's purpose is to support men's prostate cancer screening decision
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult men (50 - 69 years);
  • men with average risk for prostate cancer;
  • willing and able to provide written informed consent.

You may not qualify if:

  • unable to understand written Portuguese.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32349746DERIVED

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Sofia Baptista, MD

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Baptista, MD

CONTACT

00351910357362sofiatbaptista@gmail.com

António Soares, PhD

CONTACT

00351225513622ajasoares@cintesis.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 17, 2019

Study Start

September 1, 2019

Primary Completion

December 1, 2019

Study Completion

September 1, 2020

Last Updated

June 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Data will be made available on request