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

April 2, 2021 updated by: Montserrat Rue, Institut de Recerca Biomèdica de Lleida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • Lleida Biomedical Research Institute (IRBLLEIDA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decision aid
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
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).
Active Comparator: Control
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recerca Biomèdica de Lleida

Collaborators

Institut Català d'Oncologia
Hospital del Mar
Canary Islands Health Service

Investigators

  • Principal Investigator: Montserrat Rué, PhD, Universitat de Lleida-IRBLLEIDA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

September 14, 2017

Study Completion (Actual)

June 20, 2018

Study Registration Dates

First Submitted

February 4, 2017

First Submitted That Met QC Criteria

February 4, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI14/00113

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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