Clinical trial NCT03046004: Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making
Official title: The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Screening
Keywords: breast cancer
screening
decision aid
informed choice
decisional conflict
Lead sponsor: Institut de Recerca Biomèdica de Lleida
Sponsor class: OTHER
Collaborators: name: Hospital del Mar
name: Canary Islands Health Service
name: Institut Català d'Oncologia
First posted: 2017-02-08
Enrollment: 400
Sex: FEMALE
Minimum age (years): 49
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Informed choice
timeFrame: Two weeks after the intervention
Secondary outcomes:
measure: Breast screening attitudes
timeFrame: Two weeks after the intervention
measure: Breast screening intention
timeFrame: Two weeks after the intervention and after being invited to be screened
measure: Decisional conflict
timeFrame: Two weeks after the intervention
measure: Confidence in the decision made
timeFrame: Two weeks after the intervention
measure: Anxiety about screening participation
timeFrame: Two weeks after the intervention
measure: Worry about breast cancer
timeFrame: Two weeks after the intervention
measure: Anticipated regret
timeFrame: Two weeks after the intervention
measure: Time perspective
timeFrame: Two weeks after the intervention
measure: Perceived importance of benefit/harms of screening
timeFrame: Two weeks after the intervention
measure: Perceived risk of breast cancer
timeFrame: Two weeks after the intervention
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Lleida Biomedical Research Institute (IRBLLEIDA)
Study officials:
affiliation: Universitat de Lleida-IRBLLEIDA
name: Montserrat Rué, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.