Does a new leaflet with information about the breast cancer screening program, its benefits and risks, affect participation in the screening program?
| ISRCTN | ISRCTN13848929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13848929 |
| Secondary identifying numbers | 2019/8898/I |
- Submission date
- 22/04/2021
- Registration date
- 06/05/2021
- Last edited
- 05/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
In Catalonia, Spain, a new leaflet was designed with information about the breast cancer screening program. To our knowledge, it is not known whether the leaflet has any effect on women’s attendance. Therefore, the aim of this study was to evaluate the impact on participation of this new leaflet targeting women invited to the breast cancer screening program.
Who can participate?
The study included women aged 50 - 69 years invited to the breast cancer screening program in the catchment area of the Parc the Salut Mar in Barcelona, Spain.
What does the study involve?
This study follows the usual screening program protocol, in which invitations to participate in the screening program are sent by surface mail. Two groups were created, one group received an information leaflet on the benefits and harms of mammography screening. The other group received the usual invitation letter. We compared participation in the screening program between groups.
What are the possible benefits and risks of participating?
The possible benefit of participating is having more information about the breast cancer screening program, its benefits and risks. A possible risks of participating in the study is deciding not to participate in the screening program.
Where is the study run from?
Department of Epidemiology and Evaluation of the Hospital del Mar and IMIM (Hospital del Mar Medical Research Institute) (Spain.)
When is the study starting and how long is it expected to run for?
September 2019 to March 2020
Who is funding the study?
This work was supported by a grant from Instituto de Salud Carlos III (grant number: PI19/00007), and by the Research Network on Health Services in Chronic Diseases (RD12/0001/0015) (Spain)
Who is the main contact?
Margarita Posso, mposso@parcdesalutmar.cat
Contact information
Scientific
Department of Epidemiology and Evaluation
Passeig Marítim 25-29
Barcelona
08003
Spain
| Phone | +34 932483929 |
|---|---|
| mposso@parcdesalutmar.cat |
Public
Passeig Marítim 25-29
Barcelona
08003
Spain
 ORCID ID |
0000-0002-8587-3032 |
|---|---|
| Phone | +34 646784699 |
| 62224@parcdesalutmar.cat |
Study information
| Study design | Single-center interventional cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect of an information leaflet on breast cancer screening participation. A cluster randomized controlled trial |
| Study objectives | A new leaflet containing information about the breast cancer screening program modifies the participation rate of women invited to participate in at least three percentual points. |
| Ethics approval(s) | Approved 09/10/2019, Clinical Research Ethics Committee of the PSMAR (CEIm – Parc de Salut MAR; Dr Aiguader, 88; 08003, Barcelona, Spain; +34 93 316 06 77; ceic-psmar@imim.es), ref: 2019/8898/I |
| Health condition(s) or problem(s) studied | Breast cancer screening program |
| Intervention | -Control group: women received the usual invitation letter, that offers an appointment date to undergo mammography as part of the breast cancer screening program, without informing about the benefits and risks of participating in the screening program. -Intervention group: received an information leaflet in addition to the invitation letter. This information leaflet describes the breast cancer screening program, and how it is implemented in the region. It contains qualitative and quantitative information on breast cancer, mortality reduction due to mammography screening, the possibility and advantages of detecting early-stage cancer in participants, and explaining the mammogram. The leaflet also provides information on the potential risks of screening, overdiagnosis and overtreatment, and false positives and false negatives. The randomization unit was the processing day of the letter of invitation, and was performed as a blind random assignment using the RANDOM excel function. The follow-up period was initially set to be 90 days, but due to the COVID-19 pandemic we had to deviate from the protocol and shorten it to 30 days. |
| Intervention type | Behavioural |
| Primary outcome measure | Participation in the breast cancer screening program measured as a dichotomous variable (yes/no) and is automatically registered in an informatic application at the moment that the woman undergoes screening mammography |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2019 |
| Completion date | 08/03/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 9,640 |
| Total final enrolment | 11119 |
| Key inclusion criteria | 1. Women aged 50 to 69 years 2. Invited to participate to the Breast Cancer Screening Program between 30th September 2019 and 17th January 2020 3. Residents of six catchment areas of Barcelona |
| Key exclusion criteria | 1. Women who had moved residence outside the PSMAR catchment area 2. Census errors |
| Date of first enrolment | 30/09/2019 |
| Date of final enrolment | 17/01/2020 |
Locations
Countries of recruitment
- Spain
Study participating centre
Barcelona
08003
Spain
Sponsor information
Hospital/treatment centre
Carrer Dr. Aiguader, 88
Barcelona
08003
Spain
| Phone | +34 93 248 36 36 |
|---|---|
| 97330@parcdesalutmar.cat | |
| Website | https://www.parcdesalutmar.cat/es/epidemiologia/ |
"ROR" |
https://ror.org/032exky44 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
No information available
Results and Publications
| Intention to publish date | 01/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Margarita Posso (mposso@parcdesalutmar.cat) upon reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v1 | 27/09/2019 | 06/05/2021 | No | No |
| Results article | 03/07/2021 | 05/07/2021 | Yes | No |
Additional files
- ISRCTN13848929_PROTOCOL_v1_27Sept2019.docx
- uploaded 06/05/2021
Editorial Notes
05/07/2021: Publication reference added.
03/06/2021: The intention to publish date has been changed from 01/06/2021 to 01/09/2021.
06/05/2021: Uploaded protocol (not peer-reviewed) as an additional file. Version 1, 27 September 2019.
22/04/2021: Trial's existence confirmed by Clinical Research Ethics Committee of the PSMAR.
