Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03046004
Acronym
InforMa
Enrollment
400
Registered
2017-02-08
Start date
2016-07-01
Completion date
2018-06-20
Last updated
2021-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Screening

Keywords

breast cancer, screening, decision aid, informed choice, decisional conflict

Brief summary

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

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.

Interventions

OTHERDecision aid for breast cancer screening

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).

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.

Sponsors

Hospital del Mar
CollaboratorOTHER
Canary Islands Health Service
CollaboratorUNKNOWN
Institut Català d'Oncologia
CollaboratorOTHER
Institut de Recerca Biomèdica de Lleida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
49 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Informed choiceTwo weeks after the interventionThe primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.

Secondary

MeasureTime frameDescription
Breast screening intentionTwo weeks after the intervention and after being invited to be screenedAccording to Hersch 2015
Decisional conflictTwo weeks after the interventionAccording to Hersch 2015
Confidence in the decision madeTwo weeks after the interventionAccording to Hersch 2015
Anxiety about screening participationTwo weeks after the interventionAccording to Hersch 2015
Breast screening attitudesTwo weeks after the interventionAccording to Hersch 2015
Anticipated regretTwo weeks after the interventionAccording to Hersch 2015
Time perspectiveTwo weeks after the interventionAccording to Hersch 2015
Perceived importance of benefit/harms of screeningTwo weeks after the interventionAccording to Hersch 2015
Perceived risk of breast cancerTwo weeks after the interventionAccording to Hersch 2015
Worry about breast cancerTwo weeks after the interventionAccording to Hersch 2015

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026