Breast CancerNCT03631758
Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions
A study testing Evidence-based information and Patient Decision Aid in people with Breast Cancer, run by McMaster University at 1 site in Canada.
Trial summary
Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Read more about this study
- Who is it for?
- Ages 40 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Evidence-based information and Patient Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 1 Dec 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 40 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speaking women, 40-49 years old
- Residents of British Columbia, Nova Scotia, and Prince Edward Island
Who cannot join
- History of breast cancer or mammography in the last 12 months
- Classified as above-average risk for breast cancer (i.e., known genetic mutation linked to BC; no genetic testing, but a parent, sibling or child with a genetic mutation linked to BC; or received chest wall radiation before age 30)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: McMaster Choices Study: Evaluating the Impact of Cancer Screening Patient Decision Aids on Breast Cancer Screening Decisions
Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions.
Read the detailed description
Guidelines for breast screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about breast cancer screening in women.
- Conditions
- Breast Cancer
- Being tested
- Evidence-based information, Patient Decision Aid, Sham information
- Keywords
- Screening, Mammography, Patient Decision Aid
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based informationOther
Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).
Patient Decision AidBehavioural
Patient Decision Aid for breast cancer screening decision
Sham informationOther
Educational information not specific to mammography or cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Evidence + PDA | Experimental | Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources), plus a blog post on PDAs and the relevant decision aid from the Portal database Receives: Other: Evidence-based information; Behavioral: Patient Decision Aid |
| Evidence only | Experimental | The same evidence-based information as group 1 (Evidence + PDA), but without the PDA to quantify the effect of accessing evidence through the Portal alone Receives: Other: Evidence-based information |
| Attention control | Sham comparator | Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs Receives: Other: Sham information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale
A validated scale in which items are summed and scored to create a total score. Scores range from 0 to 100, with higher scores indicating higher decisional conflict.
Measured: Change from baseline to 6-mo
Secondary outcomes (3)
Decision quality
Decision Quality Worksheet for Mammography
Measured: Change from baseline to 6-mo
Preparation for Decision Making Scale
A validated scale, items are summed and scored to create a score of 0-100. Higher scores indicate higher preparation for decision making
Measured: Change from baseline to 6-mo
Screening behaviour
Congruency between self-reported screening status and stated decision
Measured: Change from baseline to 6-mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Jan 2019
- Primary completion31 Jan 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- Maureen Dobbins, RN, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631758
- Sponsor's protocol ID
- 4352
- Status last verified
- Oct 2023
- First submitted
- 13 Aug 2018
- Last updated
- 19 Oct 2023
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- McMaster Choices Study: Evaluating the Impact of Cancer Screening Patient Decision Aids on Breast Cancer Screening Decisions
- ClinicalTrials.gov ID
- NCT03631758
- Acronym / sponsor ID
- 4352
- Conditions
- Breast Cancer
- Keywords
- Screening, Mammography, Patient Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 15 Aug 2018 (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.
Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions.
Detailed description
Guidelines for breast screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about breast cancer screening in women.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Evidence + PDA | Experimental | Other: Evidence-based information, Behavioral: Patient Decision AidEvidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources), plus a blog post on PDAs and the relevant decision aid from the Portal database |
| Evidence only | Experimental | Other: Evidence-based informationThe same evidence-based information as group 1 (Evidence + PDA), but without the PDA to quantify the effect of accessing evidence through the Portal alone |
| Attention control | Sham comparator | Other: Sham informationInformation on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English speaking women, 40-49 years old
- Residents of British Columbia, Nova Scotia, and Prince Edward Island
Key exclusion criteria (2 listed)
- History of breast cancer or mammography in the last 12 months
- Classified as above-average risk for breast cancer (i.e., known genetic mutation linked to BC; no genetic testing, but a parent, sibling or child with a genetic mutation linked to BC; or received chest wall radiation before age 30)
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 |
|---|---|---|
| Evidence-based informationEvidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources). | Other | Evidence only, Experimental: Evidence + PDA |
| Patient Decision AidPatient Decision Aid for breast cancer screening decision | Behavioural | Experimental: Evidence + PDA |
| Sham informationEducational information not specific to mammography or cancer screening | Other | Attention control |
Primary outcome
Decisional Conflict Scale
Time frame: Change from baseline to 6-mo
A validated scale in which items are summed and scored to create a total score. Scores range from 0 to 100, with higher scores indicating higher decisional conflict.
3 secondary outcomes
Decision quality
Time frame: Change from baseline to 6-mo
Preparation for Decision Making Scale
Time frame: Change from baseline to 6-mo
Screening behaviour
Time frame: Change from baseline to 6-mo
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 19 Oct 2023.
- 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.
Maureen Dobbins, RN, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based information and Patient Decision Aid in people with Breast Cancer, run by McMaster University 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 2 inclusion and 2 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 19 Oct 2023. 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. Some participants in this study may receive a placebo. 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?
Decisional Conflict Scale (time frame: Change from baseline to 6-mo). 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 19 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.