Breast NeoplasmGIRLSNCT02914197
Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)
A study testing Full information in people with Breast Neoplasm, run by McMaster University at 1 site in Canada.
Trial summary
To trial the provision of full information on the benefits and risks of mammography in women that are eligible for breast screening. The knowledge many women have of mammography is not reflective of the recent change in evidence; it is often missing information on over-diagnosis and over-detection. Read more about this study
- Who is it for?
- Ages 47 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Full information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2017to Nov 2019
- 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 47 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient on the active roster of physicians of MUSIC (McMaster University Sentinel and Information Collaboration; McMaster Family Health Team).
- Due for a mammogram (have not had a mammogram ≥ 18 months) according to Canadian screening interval recommendations for routine screening.
Who cannot join
- Previous history of invasive or non-invasive breast cancer.
- At higher risk for breast cancer compared to the general population i.e. identified as having the BRCA1 or BRCA2 gene, immediate family member has had breast cancer.
- Have had a mammogram within the last 18 months (< 18 months).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University, Department of Family Medicine
Hamilton, Ontario, L8P1H6
Jessica Langevin, MPH, 905-525-9140 ext. 21232, langevjn@mcmaster.ca
Dee Mangin, MB ChB
About this study
Official title: Giving Information on the Risks and Limitations of Mammography Screening (GIRLS): a Randomized Controlled Trial
To trial the provision of full information on the benefits and risks of mammography in women that are eligible for breast screening. The knowledge many women have of mammography is not reflective of the recent change in evidence; it is often missing information on over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and the benefits of breast screening. In addition, universal breast screening programs are biased towards emphasizing screening. However, a mammogram is not a perfect test and there is no right or wrong decision about whether to have a screening mammogram. It is an individual woman's decision to make. To understand the effect of changing information to reflect the potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled trial of implementation of balanced information on mammography in family practice.
Read the detailed description
1:1 double-blinded randomized controlled trial of patients to receive the intervention or standard information (control) at the study start in an information package. The intervention includes a decision aid (previously developed by Hersch et al. 2015, with minor modifications to reflect the Canadian context), a YouTube video link and an invitation to attend a group information session. The intervention or standard information, depending on participants assigned study group, will be mailed or emailed to participants. The information packages will also include questionnaires to collect data on outcome measures. There will be two study waves to account for women's eligibility at different time points (i.e. when approaching a mammogram due date). The first wave of participants will receive their information package at the study start and the second wave of participants will be sent their information packages 6 months after the study start. Each wave of participants will be followed for one year. Data collection will include quantitative measures of factors relevant to the decision-making process. Screening participant rates will be measured for each wave of participants, 6 months and 12 months after their respective enrollment date. Qualitative methods will be used to obtain an understanding of clinician's perception of decision aids in a primary care setting. Outcome measures and analyses will be blinded.
- Conditions
- Breast Neoplasm
- Being tested
- Full information
- Keywords
- Decision, Mammography, Informed Choice, Full Information, Decision Aid, Self-efficacy, Shared decision making, Over-detection, Over-diagnosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full informationOther
Patients will be randomized to receive full information or standard information at the study start. The second wave will follow the same randomization process 6 months following the study start.
| Study group | Role | What they receive |
|---|---|---|
| Full information | Experimental | The intervention arm will receive full information on the risks and benefits of mammography through:
1. Decision aid
2. YouTube video
3. Group information session Receives: Other: Full information |
| Control | No intervention | Standard information leaflet for breast screening from Cancer Care Ontario |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy
Decision Self-Efficacy Scale
Measured: 1 month
Secondary outcomes (12)
Informed Choice (Knowledge)
Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.
Knowledge will be measured using the Multidimensional Measure of Informed Choice (MMIC).
Measured: 1 month
Informed Choice (Attitude)
Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.
Attitudes will be measured using the Multidimensional Measure of Informed Choice (MMIC).
Measured: 1 month
Informed Choice (Intention)
Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.
Intention to screen will be measured using a 5-point Likert scale.
Measured: 1 month
Decisional Conflict
SURE (Decisional Conflict Scale- SURE Test for clinical practice)
Measured: 1 month
Anxiety
Women will be asked about their anxiety towards participating in breast screening after reading their information pamphlet using a 4-point Likert scale.
Measured: 1 month
Trust in Medical System
MMI (Medical Mistrust Index)
Measured: 1 month
Perception of Health Provider Recommendation
Women will be asked to assess their perception of the strength of the recommendation that their health care provider makes with respect to breast screening.
Measured: 1 month
Information Relevant to the Decision Making Process
Women will be asked to describe the information that was relevant to their individual decision making process.
Measured: 1 month
Decision Regret
Decision Regret Scale
Measured: 12 month
Screening Participation
Data on a women's decision to undergo screening through mammography will be obtained from patient's electronic medical record.
Measured: 6 months and 12 months
Acceptance of a Decision Aid in Primary Care
Clinician staff will be asked to list the five best things and five worst things about the implementation of a patient focused decision aid.
Measured: 12 months
Knowledge of the Benefits and Risks of Mammography
Multiple choice question on knowledge of breast cancer mortality reduction and over-diagnosis.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start20 Nov 2017
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- David Braley and Nancy Gordon Chair in Family Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914197
- Sponsor's protocol ID
- 2016-001
- Acronym
- GIRLS
- Status last verified
- Aug 2017
- First submitted
- 22 Sep 2016
- Last updated
- 22 Mar 2018
- 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 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giving Information on the Risks and Limitations of Mammography Screening (GIRLS): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02914197
- Acronym / sponsor ID
- GIRLS / 2016-001
- Conditions
- Breast Neoplasm
- Keywords
- Decision, Mammography, Informed Choice, Full Information, Decision Aid, Self-efficacy, Shared decision making, Over-detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- David Braley and Nancy Gordon Chair in Family Medicine
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- 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.
To trial the provision of full information on the benefits and risks of mammography in women that are eligible for breast screening. The knowledge many women have of mammography is not reflective of the recent change in evidence; it is often missing information on over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and the benefits of breast screening. In addition, universal breast screening programs are biased towards emphasizing screening. However, a mammogram is not a perfect test and there is no right or wrong decision about whether to have a screening mammogram. It is an individual woman's decision to make. To understand the effect of changing information to reflect the potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled trial of implementation of balanced information on mammography in family practice.
Detailed description
1:1 double-blinded randomized controlled trial of patients to receive the intervention or standard information (control) at the study start in an information package. The intervention includes a decision aid (previously developed by Hersch et al. 2015, with minor modifications to reflect the Canadian context), a YouTube video link and an invitation to attend a group information session. The intervention or standard information, depending on participants assigned study group, will be mailed or emailed to participants. The information packages will also include questionnaires to collect data on outcome measures. There will be two study waves to account for women's eligibility at different time points (i.e. when approaching a mammogram due date). The first wave of participants will receive their information package at the study start and the second wave of participants will be sent their information packages 6 months after the study start. Each wave of participants will be followed for one year. Data collection will include quantitative measures of factors relevant to the decision-making process. Screening participant rates will be measured for each wave of participants, 6 months and 12 months after their respective enrollment date. Qualitative methods will be used to obtain an understanding of clinician's perception of decision aids in a primary care setting. Outcome measures and analyses will be blinded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full information | Experimental | Other: Full informationThe intervention arm will receive full information on the risks and benefits of mammography through: 1. Decision aid 2. YouTube video 3. Group information session |
| Control | No intervention | –Standard information leaflet for breast screening from Cancer Care Ontario |
Who may qualify
- Ages
- 47 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient on the active roster of physicians of MUSIC (McMaster University Sentinel and Information Collaboration; McMaster Family Health Team).
- Due for a mammogram (have not had a mammogram ≥ 18 months) according to Canadian screening interval recommendations for routine screening.
Key exclusion criteria (3 listed)
- Previous history of invasive or non-invasive breast cancer.
- At higher risk for breast cancer compared to the general population i.e. identified as having the BRCA1 or BRCA2 gene, immediate family member has had breast cancer.
- Have had a mammogram within the last 18 months (< 18 months).
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 |
|---|---|---|
| Full informationPatients will be randomized to receive full information or standard information at the study start. The second wave will follow the same randomization process 6 months following the study start. | Other | Full information |
Primary outcome
Self-efficacy
Time frame: 1 month
Decision Self-Efficacy Scale
12 secondary outcomes
Informed Choice (Knowledge)
Time frame: 1 month
Informed Choice (Attitude)
Time frame: 1 month
Informed Choice (Intention)
Time frame: 1 month
Decisional Conflict
Time frame: 1 month
Anxiety
Time frame: 1 month
Trust in Medical System
Time frame: 1 month
Perception of Health Provider Recommendation
Time frame: 1 month
Information Relevant to the Decision Making Process
Time frame: 1 month
Decision Regret
Time frame: 12 month
Screening Participation
Time frame: 6 months and 12 months
Acceptance of a Decision Aid in Primary Care
Time frame: 12 months
Knowledge of the Benefits and Risks of Mammography
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full information in people with Breast Neoplasm, 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 3 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 22 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dee Mangin, MBChB, DPH, FRNZCGP (905-525-9140 ext. 21219, mangind@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (time frame: 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 22 Mar 2018.