Giving Information on the Risks and Limitations of Mammography Screening (GIRLS) (GIRLS)

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasm
• Intervention / Treatment: Other: Full information

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 Type: Interventional
• Enrollment (Anticipated): 608
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dee Mangin, MBChB, DPH, FRNZCGP; Phone Number: 21219 905-525-9140; Email: mangind@mcmaster.ca
• Study Contact Backup: Name: Jessica Langevin, MPH; Phone Number: 21232 905-525-9140; Email: langevjn@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8P1H6
      • Recruiting
      • McMaster University, Department of Family Medicine
      • Contact: Jessica Langevin, MPH; Phone Number: 21232 905-525-9140; Email: langevjn@mcmaster.ca
      • Principal Investigator: Dee Mangin, MB ChB
      • Principal Investigator: Dale Guenter, MD
      • Principal Investigator: Cathy Risdon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 47 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Full information; The intervention arm will receive full information on the risks and benefits of mammography through: Decision aid; YouTube video; Group information session	Other: Full information; 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.
NO_INTERVENTION: Control; Standard information leaflet for breast screening from Cancer Care Ontario

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy	Decision Self-Efficacy Scale	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	1 month
Decisional Conflict	SURE (Decisional Conflict Scale- SURE Test for clinical practice)	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.	1 month
Trust in Medical System	MMI (Medical Mistrust Index)	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.	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.	1 month
Decision Regret	Decision Regret Scale	12 month
Screening Participation	Data on a women's decision to undergo screening through mammography will be obtained from patient's electronic medical record.	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.	12 months
Knowledge of the Benefits and Risks of Mammography	Multiple choice question on knowledge of breast cancer mortality reduction and over-diagnosis.	1 month

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: David Braley and Nancy Gordon Chair in Family Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2017
• Primary Completion (ANTICIPATED): November 1, 2018
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (ESTIMATE): September 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Mammography; Shared decision making; Self-efficacy; Decision Aid; Decision; Informed Choice; Full Information; Over-detection; Over-diagnosis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2016-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No