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Trial record 5 of 33681 for:    value

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

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ClinicalTrials.gov Identifier: NCT03988673
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
NOVA Medical School
Georgetown University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Decision aid with implicit values clarification method (booklet or website) Other: Decision aid with explicit values clarification method (booklet or website) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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).




Primary Outcome Measures :
  1. Perceived clarity of personal values [ Time Frame: 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 :
  1. Decisional Conflict [ Time Frame: 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].

  2. % of patients with preference to undergo PSA screening (screening intention; questionnaire) [ Time Frame: 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.

  3. % of patients who underwent PSA screening (questionnaire) [ Time Frame: 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



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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   the intervention's purpose is to support men's prostate cancer screening decision
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988673


Contacts
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Contact: Sofia Baptista, MD 00351910357362 sofiatbaptista@gmail.com
Contact: António Soares, PhD 00351225513622 ajasoares@cintesis.eu

Sponsors and Collaborators
Universidade do Porto
NOVA Medical School
Georgetown University
Investigators
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Principal Investigator: Sofia Baptista, MD Universidade do Porto

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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03988673     History of Changes
Other Study ID Numbers: DA-VCM
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be made available on request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases