NCT03046004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

February 4, 2017

Last Update Submit

April 2, 2021

Conditions

Breast Cancer Screening

Keywords

breast cancerscreeningdecision aidinformed choicedecisional conflict

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Breast screening attitudes

    Two weeks after the intervention

  • Breast screening intention

    Two weeks after the intervention and after being invited to be screened

  • Decisional conflict

    Two weeks after the intervention

  • Confidence in the decision made

    Two weeks after the intervention

  • Anxiety about screening participation

    Two weeks after the intervention

  • +5 more secondary outcomes

Study Arms (2)

Decision aid

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Decision aid for breast cancer screeningOTHER

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).

Decision aid
Standard leafletOTHER

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.

Control

Eligibility Criteria

Age49 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Previous history of breast cancer
  • Difficulty speaking Spanish or Catalan
  • Cognitive impairment to understand or complete the materials based on the interviewer judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lleida Biomedical Research Institute (IRBLLEIDA)

Lleida, 25198, Spain

Location

Related Publications (5)

  • Toledo-Chavarri A, Rue M, Codern-Bove N, Carles-Lavila M, Perestelo-Perez L, Perez-Lacasta MJ, Feijoo-Cid M; InforMa Study Group. A qualitative study on a decision aid for breast cancer screening: Views from women and health professionals. Eur J Cancer Care (Engl). 2017 May;26(3). doi: 10.1111/ecc.12660. Epub 2017 Feb 1.

    PMID: 28145105BACKGROUND

  • Perez-Lacasta MJ, Martinez-Alonso M, Garcia M, Sala M, Perestelo-Perez L, Vidal C, Codern-Bove N, Feijoo-Cid M, Toledo-Chavarri A, Cardona A, Pons A, Carles-Lavila M, Rue M; with the InforMa Group. Effect of information about the benefits and harms of mammography on women's decision making: The InforMa randomised controlled trial. PLoS One. 2019 Mar 26;14(3):e0214057. doi: 10.1371/journal.pone.0214057. eCollection 2019.

    PMID: 30913217BACKGROUND

  • Pons-Rodriguez A, Martinez-Alonso M, Perestelo-Perez L, Garcia M, Sala M, Rue M; en nombre del grupo InforMa; El grupo InforMa esta formado por. [Informed choice in breast cancer screening: the role of education]. Gac Sanit. 2021 May-Jun;35(3):243-249. doi: 10.1016/j.gaceta.2020.01.002. Epub 2020 Mar 12. Spanish.

    PMID: 32173050BACKGROUND

  • Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1642-52. doi: 10.1016/S0140-6736(15)60123-4. Epub 2015 Feb 18.

    PMID: 25701273RESULT

  • Carles M, Martinez-Alonso M, Pons A, Perez-Lacasta MJ, Perestelo-Perez L, Sala M, Vidal C, Garcia M, Toledo-Chavarri A, Codern N, Feijoo-Cid M, Romero A, Pla R, Soler-Gonzalez J, Castells X, Rue M; InforMa Group. The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial. Trials. 2017 Sep 12;18(1):426. doi: 10.1186/s13063-017-2161-7.

    PMID: 28899412DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Montserrat Rué, PhD

    Universitat de Lleida-IRBLLEIDA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2017

First Posted

February 8, 2017

Study Start

July 1, 2016

Primary Completion

September 14, 2017

Study Completion

June 20, 2018

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)