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Completed

NCT Number: NCT03046004

Effect of Information About the Benefits and Harms of Mammography 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.

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Key information

Age range

49 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lleida Biomedical Research Institute (IRBLLEIDA)

Lleida, 25198, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision aid for breast cancer screening

Other

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 leaflet

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Breast screening attitudes

    Time frame: Two weeks after the intervention

    According to Hersch 2015

  2. Breast screening intention

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

    According to Hersch 2015

  3. Decisional conflict

    Time frame: Two weeks after the intervention

    According to Hersch 2015

  4. Confidence in the decision made

    Time frame: Two weeks after the intervention

    According to Hersch 2015

  5. Anxiety about screening participation

    Time frame: Two weeks after the intervention

    According to Hersch 2015

  6. Worry about breast cancer

    Time frame: Two weeks after the intervention

    According to Hersch 2015

  7. Anticipated regret

    Time frame: Two weeks after the intervention

    According to Hersch 2015

  8. Time perspective

    Time frame: Two weeks after the intervention

    According to Hersch 2015

  9. Perceived importance of benefit/harms of screening

    Time frame: Two weeks after the intervention

    According to Hersch 2015

  10. Perceived risk of breast cancer

    Time frame: Two weeks after the intervention

    According to Hersch 2015

Sponsors and collaborators

Lead sponsor

Institut de Recerca Biomèdica de Lleida

Other

Collaborators

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

Registry information

Official study title

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

Acronym: InforMa

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 8, 2017
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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