Clinical trial · Interventional
Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)
Giving Information on the Risks and Limitations of Mammography Screening (GIRLS): a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Full information | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Full information
- description
- 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
- interventionNames
- Other: Full information
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard information leaflet for breast screening from Cancer Care Ontario
Primary outcomes (1)
- measure
- Self-efficacy
- timeFrame
- 1 month
- description
- Decision Self-Efficacy Scale
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 47 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available