Neoplasm, Breast Clinical Trial
— BESTaOfficial title:
Towards High, Equal and Informed Participation in Swedish Cancer Screening - the BESTa Project.
NCT number | NCT05512260 |
Other study ID # | BESTa |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | December 31, 2024 |
Background: Sweden has a long tradition of organized national population-based screening programs. Participation rates differ between programs and regions, are relatively high in some groups, but lower in other. To apply an equity perspective on screening, it is desired that individuals make an informed decision on knowledge rather than ignorance, misconceptions, or fear. Decision Aids (DAs) are set to deliver information about different health care options and to help individuals make visible values connected to the options available. DAs are not meant to guide individuals to choose one option over the another. The advantage of an individual Decision Aid (iDA) is that individuals gain knowledge on cancer and screening entering one webpage with possibility to communicate with health professionals and thereafter make their decision regarding participate. The primary objective is therefore to develop and implement a web-based iDA for individuals invited to cancer screening in Sweden. The secondary objective is to evaluate the implemented web-based iDA. Methods: This study has an evaluative approach with both a process-, an implementation and an outcome evaluation. Multiple methods will be used including patient reported data, focus group discussions and individual interviews using the think aloud technique. The project is based on the framework from The International Patient Decision Aid Standards (IPDAS) and the proposed model development process for DAs as presented by Coulter et al. Individuals aged 23-74, including women aged (the cervical- and breast- and bowel cancer screening module) and men aged (the bowel cancer screening module), will be included in the developmental process. Efforts will be made to recruit participants with disabilities, who live outside society and who are foreign born. Discussion: To the best of our knowledge the present study is the first aiming at developing an iDA for usage in Swedish context, The iDA is intended to contribute so that individuals invited to screening base their decision on knowledge and with a clear picture of their values and preferences, rather than ignorance, misconceptions, or fear. Furthermore, the iDA is expected to increase knowledge and raise awareness in general about cancer and cancer screening in society.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 23 Years to 74 Years |
Eligibility | Inclusion Criteria: - women aged 23 -74 - men aged 60 - 74 Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Huddinge |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Dalarna University, Jonkoping University, Karolinska University Hospital, Leiden University, Malmö University, Umeå University |
Sweden,
Charles C, Gafni A. The vexing problem of defining the meaning, role and measurement of values in treatment decision-making. J Comp Eff Res. 2014 Mar;3(2):197-209. doi: 10.2217/cer.13.91. — View Citation
Coulter A, Stilwell D, Kryworuchko J, Mullen PD, Ng CJ, van der Weijden T. A systematic development process for patient decision aids. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S2. doi: 10.1186/1472-6947-13-S2-S2. Epub 2013 Nov 29. — View Citation
Drennan J. Cognitive interviewing: verbal data in the design and pretesting of questionnaires. J Adv Nurs. 2003 Apr;42(1):57-63. doi: 10.1046/j.1365-2648.2003.02579.x. — View Citation
Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14. — View Citation
Essink-Bot ML, Dekker E. Equal access to colorectal cancer screening. Lancet. 2016 Feb 20;387(10020):724-6. doi: 10.1016/S0140-6736(15)01221-0. Epub 2015 Dec 9. No abstract available. — View Citation
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. — View Citation
Schwartz PH, O'Doherty KC, Bentley C, Schmidt KK, Burgess MM. Layperson Views about the Design and Evaluation of Decision Aids: A Public Deliberation. Med Decis Making. 2021 Jul;41(5):527-539. doi: 10.1177/0272989X21998980. Epub 2021 Apr 5. — View Citation
Zidar MN, Larm P, Tillgren P, Akhavan S. Non-attendance of mammographic screening: the roles of age and municipality in a population-based Swedish sample. Int J Equity Health. 2015 Dec 30;14:157. doi: 10.1186/s12939-015-0291-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Satisfaction with the iDA and the decision | Satisfaction with the iDA and the decision of iDA users will be evaluated with self-reported questions including response options such as yes/no/do not know | up to 12 months | |
Primary | Comprehensibility regarding iDA content | The iDA will be evaluated for its content using qualitative methods such as individual interviews, focus group discussions and cognitive interviewing | up to 10 months | |
Primary | Usability regarding iDA format | The iDA will be evaluated for its usability using qualitative methods such as individual interviews, focus group discussions and cognitive interviewing | up to 10 months | |
Primary | Feasibility regarding iDA format | The iDA will be evaluated for its feasibility using qualitative methods such as individual interviews, focus group discussions and cognitive interviewing | up to 10 months | |
Secondary | Self-reported knowledge of cancer and screening | Knowledge of cancer and screening of iDA users will be evaluated with self-reported questions including response options such as yes/no/do not know | up to 12 months | |
Secondary | Self-reported attitudes and preferences to cancer screening | Attitudes and preferences to screening of iDA users will be evaluated with self-reported questions including response options such as yes/no/do not know | up to 12 months | |
Secondary | Self-reported lifestyle behaviors | Lifestyle behaviors, such as physical activity, food intake, smoking and alcohol of iDA users will be evaluated with self-reported questions including response options such as yes/no/do not know | up to 12 months |
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