Development, Implementation and Evaluation of an Individual Decision Aid in Swedish Cancer Screening Programs

NCT05512260 | Withdrawn

• 1 other identifier: BESTa
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neoplasm, Breast; Neoplasm, Ovarian; Neoplasm, Colorectal

Keywords

Decision Support Techniques; Shared; Decision Making; Health promotion; Early detection of cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Self-reported knowledge of cancer and screening

  up to 12 months

• Self-reported attitudes and preferences to cancer screening

  up to 12 months

• Self-reported lifestyle behaviors

  up to 12 months

Other Outcomes (1)

• Satisfaction with the iDA and the decision

  up to 12 months

Study Arms (1)

Women aged 23 -74 and men aged 60 - 74 invited to population based cancer screening

OTHER

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.

Device: Individual decision aid (iDA)

Interventions

Individual decision aid (iDA) DEVICE

A web-based iDA (accessible online with various content), will be developed towards individuals approached to cancer screening, although public and accessible to all who are interested in cancer and screening. DAs in screening usually include information on the disease, screening, screening tests, benefits and harms and some value clarification exercise (e.g., interactive questions) aiming at shedding light on the individual´s values and preferences, knowledge and lifestyle.

Also known as: Decision aid in paper format

Women aged 23 -74 and men aged 60 - 74 invited to population based cancer screening

Eligibility Criteria

• Age: 23 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged 23 -74
• men aged 60 - 74

You may not qualify if:

• none

Sponsors & Collaborators

• Dalarna University: collaborator
• Karolinska University Hospital: collaborator
• Malmö University: collaborator
• Umeå University: collaborator
• Leiden University: collaborator
• Karolinska Institutet: lead
• Jonkoping University: collaborator

Study Sites (1)

Karolinska Institutet

Huddinge, 14152, Sweden

Location

Related Publications (10)

• 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.

  PMID: 26715453 BACKGROUND

• Fritzell 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 BACKGROUND

• 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.

  PMID: 24645693 BACKGROUND

• 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.

  PMID: 16908462 BACKGROUND

• 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.

  PMID: 24625093 BACKGROUND

• 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.

  PMID: 33813928 BACKGROUND

• 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.

  PMID: 12641812 BACKGROUND

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 BACKGROUND

• 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.

  PMID: 26680216 BACKGROUND

• Fritzell K, Wangmar J, Hedberg B, Woudstra A, Forsberg A, Kottorp A, Franklin KA, Jervaeus A. Making the BEST Decision-the BESTa Project: Description of the Design and Alpha Phases as Part of the Development of a Digital Decision Aid for Cancer Screening in Sweden. J Cancer Educ. 2026 Mar;41(1):123-136. doi: 10.1007/s13187-025-02633-y. Epub 2025 Apr 26.

  PMID: 40285812 RESULT

Related Links

• The use of think-aloud methods in qualitative research an introduction to think-aloud methods.
• International Patient Decision Aid Standards IPDAS.

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kaisa Fritzell, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: August 23, 2022
• Study Start: March 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

SE (1)