Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making

Study Overview
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Brief Summary
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The aim of this study is to assess the effect of receiving information about the benefits and harms of mammography screening on informed choice, decisional conflict, intention to participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). The sample of participants is composed by 400 women from Catalonia and the Canary Islands (Spain) who will receive their first invitation to participate in the EDBCP of the Public Health Service in a period of 2-4 months.

Detailed Description
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The selected women will receive a letter of invitation with information about the study. In the following 1-2 weeks they will receive a phone call to confirm that they have received the mailed letter and to assess the inclusion criteria. If they agree to participate in the study, they will be asked for informed consent. All the participants will receive a first questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. Trained interviewers will collect the responses by phone for women who prefer this method. Once the pre-intervention survey is completed, women will receive the leaflet (intervention or control) via regular mail. Two weeks later, the participants will be contacted again to collect the post-intervention survey (15-20 minutes), via web or by phone. Participation in the mammographic exams of the EDBCP will be collected in the three-month period following the corresponding invitation letter.

Official Title
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The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making

Conditions
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Breast Cancer Screening

Intervention / Treatment
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* Other: Decision aid for breast cancer screening
* Other: Standard leaflet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 49-50 who - in 2-4 months - will be invited to participate for the first time in the EDBCP of the Institut Hospital del Mar d'Investigacions Mèdiques (IMIM, Barcelona), ICO-Hospitalet (Hospitalet de Llobregat), Lleida Health Region, and the Canary Islands. Women with low health literacy will be included Exclusion Criteria: Previous history of breast cancer Difficulty speaking Spanish or Catalan Cognitive impairment to understand or complete the materials based on the interviewer judgment

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision aid<br>Women in the intervention arm will receive a leaflet with detailed information on the benefits (breast cancer mortality reduction, less intensive treatments) and harms (false positive results and overdiagnosis). | Other: Decision aid for breast cancer screening<br>* Women in the intervention arm will receive a leaflet with detailed information on the benefits (breast cancer mortality reduction, less intensive treatments) and harms (false positive results and overdiagnosis).<br>|
| Active Comparator: Control<br>Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial exams of the EDBCP. | Other: Standard leaflet<br>* Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial exams of the EDBCP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Informed choice | The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015. | Two weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast screening attitudes | According to Hersch 2015 | Two weeks after the intervention | 
| Breast screening intention | According to Hersch 2015 | Two weeks after the intervention and after being invited to be screened | 
| Decisional conflict | According to Hersch 2015 | Two weeks after the intervention | 
| Confidence in the decision made | According to Hersch 2015 | Two weeks after the intervention | 
| Anxiety about screening participation | According to Hersch 2015 | Two weeks after the intervention | 
| Worry about breast cancer | According to Hersch 2015 | Two weeks after the intervention | 
| Anticipated regret | According to Hersch 2015 | Two weeks after the intervention | 
| Time perspective | According to Hersch 2015 | Two weeks after the intervention | 
| Perceived importance of benefit/harms of screening | According to Hersch 2015 | Two weeks after the intervention | 
| Perceived risk of breast cancer | According to Hersch 2015 | Two weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, decision aid, informed choice, decisional conflict, breast cancer