Patient Educational MaterialsNCT03222466
Patient Educational Materials for Prostate Cancer Screening
A study testing Co-created PEM in people with Patient Educational Materials, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA) test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have disseminated patient educational materials (PEMs)… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Educational Materials
- What is being tested?
- Co-created PEM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 573 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2017to 27 Oct 2017
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking men aged 40+ years will be eligible to take part in the project if they have never been diagnosed with prostate cancer and do not have any signs or symptoms of prostate cancer.
Who cannot join
- Individuals will not be eligible for the project if they indicate that they are a health care professional or have any conflicts of interest relevant to the guideline topic (e.g., owning shares in a company related to prostate cancer treatment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial to Assess Whether Co-creating Patient Educational Materials With Patients Has Added Value Over Researchers and Clinicians Developing Patient Education Materials and Engaging Patients During Usability Testing Only.
Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA) test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men remain confused about screening harms and benefits. One potential contributing factor may be that PEMs are typically developed by researchers and clinicians and may not address patient barriers to change. The investigators will assess whether a PSA screening PEM that is co-created with patients provides added value over PEMs developed using the traditional approach (i.e., researchers and clinicians develop a PEM with patient involvement in usability testing only. The investigators will also assess satisfaction with the engagement process and calculate the costs and resources required for each method (i.e. co-creation, usability, and recommendations only). This study will generate a PSA screening PEM to help patients make evidence-based screening decisions. It will also help Ontario organizations, including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening and other areas of preventive health care, such as breast and colorectal cancer screening.
- Conditions
- Patient Educational Materials
- Being tested
- Co-created PEM
- Keywords
- Patient educational materials; prostate cancer; co-creation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-created PEMOther
A co-created PEM has been designed in collaboration with patients.
| Study group | Role | What they receive |
|---|---|---|
| Co-created PEM | Experimental | A co-created PEM has been designed in collaboration with patients. Participants receiving the intervention will be asked to read and answer questions before and after viewing the co-created PEM. Receives: Other: Co-created PEM |
| Traditional PEM | No intervention | Participants will be asked to read and answer questions before and after viewing the traditional PEM created by clinicians and researchers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pretest-posttest change in prostate cancer screening decisional conflict and intention to be screened between the co-created PEM group and the traditional PEM group.
The investigators will assess differences and changes in prostate cancer screening decisional conflict and intention to be screened for the co-created PEM group and the traditional PEM group using repeated measures ANOVAs.
Measured: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Secondary outcomes (4)
Pretest-posttest change in knowledge of prostate cancer screening
The investigators will assess the differences in the pretest-posttest change in prostate cancer screening knowledge between the co-created PEM group and the traditional PEM group using a 7-item knowledge measure. Assessed by conducting a repeated measures analysis of variance (ANOVA).
Measured: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Comparison of PEM usability
The investigators will assess the differences between the two study arms in PEM/recommendation usability using a one-way ANOVA
Measured: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Participant preference of PEM
The investigators will evaluate participants' preferred material (co-created or traditional PEM). Use a chi-square test to analyze the difference in the proportion of patients who prefer each type of material.
Measured: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month
Resources use for PEM development
The investigators will record the resources required (e.g., personnel hours and participant reimbursement) for a health care organization to develop a co-created PEM in comparison to a PEM created by clinicians and researchers.
Measured: This measure will be assessed after the intervention (survey) is administered (i.e., post analysis), up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start6 Oct 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Educational MaterialsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222466
- Sponsor's protocol ID
- SMH REB #:16-376
- Status last verified
- Oct 2017
- First submitted
- 11 Jul 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Assess Whether Co-creating Patient Educational Materials With Patients Has Added Value Over Researchers and Clinicians Developing Patient Education Materials and Engaging Patients During Usability Testing Only.
- ClinicalTrials.gov ID
- NCT03222466
- Acronym / sponsor ID
- SMH REB #:16-376
- Conditions
- Patient Educational Materials
- Keywords
- Patient educational materials; prostate cancer; co-creation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 19 Jul 2017 (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.
Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA) test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men remain confused about screening harms and benefits. One potential contributing factor may be that PEMs are typically developed by researchers and clinicians and may not address patient barriers to change. The investigators will assess whether a PSA screening PEM that is co-created with patients provides added value over PEMs developed using the traditional approach (i.e., researchers and clinicians develop a PEM with patient involvement in usability testing only. The investigators will also assess satisfaction with the engagement process and calculate the costs and resources required for each method (i.e. co-creation, usability, and recommendations only). This study will generate a PSA screening PEM to help patients make evidence-based screening decisions. It will also help Ontario organizations, including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening and other areas of preventive health care, such as breast and colorectal cancer screening.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-created PEM | Experimental | Other: Co-created PEMA co-created PEM has been designed in collaboration with patients. Participants receiving the intervention will be asked to read and answer questions before and after viewing the co-created PEM. |
| Traditional PEM | No intervention | –Participants will be asked to read and answer questions before and after viewing the traditional PEM created by clinicians and researchers. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking men aged 40+ years will be eligible to take part in the project if they have never been diagnosed with prostate cancer and do not have any signs or symptoms of prostate cancer.
Key exclusion criteria (1 listed)
- Individuals will not be eligible for the project if they indicate that they are a health care professional or have any conflicts of interest relevant to the guideline topic (e.g., owning shares in a company related to prostate cancer treatment).
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 |
|---|---|---|
| Co-created PEMA co-created PEM has been designed in collaboration with patients. | Other | Co-created PEM |
Primary outcome
Pretest-posttest change in prostate cancer screening decisional conflict and intention to be screened between the co-created PEM group and the traditional PEM group.
Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
The investigators will assess differences and changes in prostate cancer screening decisional conflict and intention to be screened for the co-created PEM group and the traditional PEM group using repeated measures ANOVAs.
4 secondary outcomes
Pretest-posttest change in knowledge of prostate cancer screening
Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Comparison of PEM usability
Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Participant preference of PEM
Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month
Resources use for PEM development
Time frame: This measure will be assessed after the intervention (survey) is administered (i.e., post analysis), up to 1 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-created PEM in people with Patient Educational Materials, run by Unity Health Toronto at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pretest-posttest change in prostate cancer screening decisional conflict and intention to be screened between the co-created PEM group and the traditional PEM group. (time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2017.