Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital del Mar | OTHER |
| Canary Islands Health Service | UNKNOWN |
| Institut Català d'Oncologia | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Breast screening attitudes | According to Hersch 2015 | Two weeks after the intervention |
| Breast screening intention | According to Hersch 2015 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Montserrat Rué, PhD | Universitat de Lleida-IRBLLEIDA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lleida Biomedical Research Institute (IRBLLEIDA) | Lleida | 25198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28145105 | Background | 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. | |
| 30913217 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Two weeks after the intervention and after being invited to be screened |
| Decisional conflict | According to Hersch 2015 | Two weeks after the intervention |
| Confidence in the decision made | According to Hersch 2015 | Two weeks after the intervention |
| Anxiety about screening participation | According to Hersch 2015 | Two weeks after the intervention |
| Worry about breast cancer | According to Hersch 2015 | Two weeks after the intervention |
| Anticipated regret | According to Hersch 2015 | Two weeks after the intervention |
| Time perspective | According to Hersch 2015 | Two weeks after the intervention |
| Perceived importance of benefit/harms of screening | According to Hersch 2015 | Two weeks after the intervention |
| Perceived risk of breast cancer | According to Hersch 2015 | Two weeks after the intervention |
| 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. |
| 32173050 | Background | 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. |
| 25701273 | Result | 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. |
| 28899412 | Derived | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |