AzTrials
AzTrials

Breast Cancer ScreeningInforMaNCT03046004

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

A study testing Decision aid for breast cancer screening and Standard leaflet in people with Breast Cancer Screening, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 49 to 50 years, women only
Conditions the study is for
Breast Cancer Screening
What is being tested?
Decision aid for breast cancer screening and Standard leaflet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteSpain
Study dates
1 Jul 2016to 20 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 49 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Lleida Biomedical Research Institute (IRBLLEIDA)

    Lleida, 25198

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Decision aid for breast cancer screening, Standard leaflet
Keywords
breast cancer, screening, decision aid, informed choice, decisional conflict
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • 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.

Study groups in NCT03046004
Study groupRoleWhat they receive
Decision aidExperimentalWomen 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).
Receives: Other: Decision aid for breast cancer screening
ControlActive comparatorWomen 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.
Receives: Other: Standard leaflet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Informed choice

    The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.

    Measured: Two weeks after the intervention

Secondary outcomes (10)

  1. Breast screening attitudes

    According to Hersch 2015

    Measured: Two weeks after the intervention

  2. Breast screening intention

    According to Hersch 2015

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

  3. Decisional conflict

    According to Hersch 2015

    Measured: Two weeks after the intervention

  4. Confidence in the decision made

    According to Hersch 2015

    Measured: Two weeks after the intervention

  5. Anxiety about screening participation

    According to Hersch 2015

    Measured: Two weeks after the intervention

  6. Worry about breast cancer

    According to Hersch 2015

    Measured: Two weeks after the intervention

  7. Anticipated regret

    According to Hersch 2015

    Measured: Two weeks after the intervention

  8. Time perspective

    According to Hersch 2015

    Measured: Two weeks after the intervention

  9. Perceived importance of benefit/harms of screening

    According to Hersch 2015

    Measured: Two weeks after the intervention

  10. Perceived risk of breast cancer

    According to Hersch 2015

    Measured: Two weeks after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2017 (estimated)
  2. Study start1 Jul 2016
  3. Primary completion14 Sep 2017
  4. Study completion20 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03046004
Sponsor's protocol ID
PI14/00113
Acronym
InforMa
Status last verified
Apr 2021
First submitted
4 Feb 2017
Last updated
6 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28145105

  • 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.

    PubMed 30913217

  • 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.

    PubMed 32173050

  • 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.

    PubMed 25701273

  • 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.

    PubMed 28899412

Questions about this trial

What is this clinical trial studying?

A study testing Decision aid for breast cancer screening and Standard leaflet in people with Breast Cancer Screening, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Informed choice (time frame: Two weeks after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03046004, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in