Clinical trial · Interventional
Development, Implementation and Evaluation of an Individual Decision Aid in Swedish Cancer Screening Programs
Towards High, Equal and Informed Participation in Swedish Cancer Screening - the BESTa Project.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm, Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm, Ovarian | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individual decision aid (iDA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Women aged 23 -74 and men aged 60 - 74 invited to population based cancer screening
- description
- Women aged 23 -74 targeted for breast cancer, cervical and bowel screening and men aged 60-74 targeted for bowel screening will be invited to the project. Efforts will be made to recruit participants who normally do not participate in research and screening, such as those with various disabilities, participants who live outside society and foreign born.
- interventionNames
- Device: Individual decision aid (iDA)
Primary outcomes (3)
- measure
- Comprehensibility regarding iDA content
- timeFrame
- up to 10 months
- description
- The iDA will be evaluated for its content using qualitative methods such as individual interviews, focus group discussions and cognitive interviewing
- measure
- Usability regarding iDA format
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 23 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * women aged 23 -74 * men aged 60 - 74 Exclusion Criteria: * none
References
Publications (10)
- BACKGROUNDZidar 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. PMID 26715453
- BACKGROUNDFritzell K, Hedberg B, Woudstra A, Forsberg A, Sventelius M, Kottorp A, Jervaeus A. Making the BEST decision-the BESTa project development, implementation and evaluation of a digital Decision Aid in Swedish cancer screening programmes- a description of a research project. PLoS One. 2023 Dec 12;18(12):e0294332. doi: 10.1371/journal.pone.0294332. eCollection 2023. PMID 38085710
- BACKGROUNDCharles 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. PMID 24645693
- BACKGROUNDElwyn 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. PMID 16908462
- BACKGROUNDCoulter 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. PMID 24625093
- BACKGROUNDSchwartz 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.