Healthy VolunteersNCT03988673
Comparison of Explicit, Implicit and no Values Clarification Decision Aids for Men Considering Prostate Cancer Screening
A study testing Decision aid with implicit values clarification method (booklet or website) and Decision aid with explicit values clarification method (booklet or website) in people with Healthy Volunteers, run by Universidade do Porto.
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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Decision aid with implicit values clarification method (booklet or website) and Decision aid with explicit values clarification method (booklet or website)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult men (50 - 69 years);
- men with average risk for prostate cancer;
- willing and able to provide written informed consent.
Who cannot join
- unable to understand written Portuguese.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Decision aid with implicit values clarification method (booklet or website), Decision aid with explicit values clarification method (booklet or website)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Decision aid with explicit values clarification method (booklet or website) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: immediately after the intervention
Secondary outcomes (3)
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].
Measured: 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.
Measured: 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
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study startSep 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- NOVA Medical School, Georgetown University
- Responsible party
- Sponsor
- Investigators
- Sofia Baptista, MD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988673
- Sponsor's protocol ID
- DA-VCM
- Status last verified
- May 2019
- First submitted
- 3 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available on request
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.
PubMed 32349746
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03988673
- Acronym / sponsor ID
- DA-VCM
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- NOVA Medical School, Georgetown University
- Study start
- Sep 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Decision aid with implicit values clarification method (booklet or website)decision aid with information plus an implicit VCM |
| decision aid with explicit VCM | Active comparator | Other: Decision aid with explicit values clarification method (booklet or website)decision aid with information plus an explicit VCM |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult men (50 - 69 years);
- men with average risk for prostate cancer;
- willing and able to provide written informed consent.
Key exclusion criteria (1 listed)
- unable to understand written Portuguese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | 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). | Other | decision aid with explicit VCM |
Primary outcome
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].
3 secondary outcomes
Decisional Conflict
Time frame: immediately after the intervention
% of patients with preference to undergo PSA screening (screening intention; questionnaire)
Time frame: before and immediately after the intervention
% of patients who underwent PSA screening (questionnaire)
Time frame: 6 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Derived from this study: PubMed 32349746Baptista 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.
- Individual participant dataSharing planned: No. Data will be made available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Baptista, MD principal investigator
Universidade do Porto
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid with implicit values clarification method (booklet or website) and Decision aid with explicit values clarification method (booklet or website) in people with Healthy Volunteers, run by Universidade do Porto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia Baptista, MD (00351910357362, sofiatbaptista@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived clarity of personal values (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03988673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.