Clinical trial NCT02914197: Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)
Official title: Giving Information on the Risks and Limitations of Mammography Screening (GIRLS): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasm
Keywords: Decision
Mammography
Informed Choice
Full Information
Decision Aid
Self-efficacy
Shared decision making
Over-detection
Over-diagnosis
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: David Braley and Nancy Gordon Chair in Family Medicine
First posted: 2016-09-26
Enrollment: 608
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Self-efficacy
timeFrame: 1 month
Secondary outcomes:
measure: Informed Choice (Knowledge)
timeFrame: 1 month
measure: Informed Choice (Attitude)
timeFrame: 1 month
measure: Informed Choice (Intention)
timeFrame: 1 month
measure: Decisional Conflict
timeFrame: 1 month
measure: Anxiety
timeFrame: 1 month
measure: Trust in Medical System
timeFrame: 1 month
measure: Perception of Health Provider Recommendation
timeFrame: 1 month
measure: Information Relevant to the Decision Making Process
timeFrame: 1 month
measure: Decision Regret
timeFrame: 12 month
measure: Screening Participation
timeFrame: 6 months and 12 months
measure: Acceptance of a Decision Aid in Primary Care
timeFrame: 12 months
measure: Knowledge of the Benefits and Risks of Mammography
timeFrame: 1 month
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University, Department of Family Medicine
state: Ontario
Study officials:
References: