Clinical trial NCT05512260: Development, Implementation and Evaluation of an Individual Decision Aid in Swedish Cancer Screening Programs
Official title: Towards High, Equal and Informed Participation in Swedish Cancer Screening - the BESTa Project.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasm, Colorectal
Neoplasm, Breast
Neoplasm, Ovarian
Keywords: Decision Support Techniques
Shared
Decision Making
Health promotion
Early detection of cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Jonkoping University
name: Malmö University
name: Umeå University
name: Leiden University
name: Dalarna University
name: Karolinska University Hospital
First posted: 2022-08-23
Enrollment: 220
Sex: ALL
Minimum age (years): 23
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Detailed description: INTRODUCTION AND RATIONALE For cancer screening programs to be effective, a high willingness from seemingly healthy individuals to participate is a prerequisite. Participation rates differ and are relatively high in some population groups but at the same time low in other groups. It is well known that individuals with lower socioeconomic status, ethnic minorities and individuals with disabilities participate to a limited extent in cancer screening. A decision aid (DA) is set to deliver information about different health care options and to help individuals make their values visible connected to the options available. Using a DA in connection to cancer screening can increase participation based on knowledge rather than misconception or fear.

The present project is based on the theoretical framework of shared decision making (SDM), with the overarching goal to improve the quality of health care decisions. SDM in this project is based on the work of Charles and Gafni with three cornerstones important for the decision-making process: information/knowledge - to make an informed decision persons need information to gain knowledge about e.g., pros and cons; Values/preferences - persons process their options in relation to attitudes and behaviors; and Involvement - of both the individual and health care professionals.

To date, no DA for any of the screening programs exist in Sweden why this project is warranted. By designing the communication strategies in various ways, regarding information about screening options, and to help individuals construct, clarify and communicate personal values, the researchers intention is to support the decision-making process and to address and acknowledge the equity perspective.

METHODS

Phase 1

Design This study has an evaluative approach encompassing both a process-, an implementation and an outcome evaluation. Multiple methods will be used to answer the research questions including patient reported data, focus group discussions and individual interviews using the think aloud technique. The project is based on the framework from IPDAS and the proposed model development process for DAs, as presented by Coulter et al.

Procedure and outcomes

The procedure will follow the model development process for DAs, applying the following steps:

1. Define scope - a description of breast, cervix and bowel cancer including screening will be formulated, information will be gathered regarding treatment, screening tests, true positive true negative results, risks, and benefits with screening vs. non-screening and detection probabilities. The target audience is all individuals invited to cancer screening.
2. Steering group - a multidisciplinary group will be formed with stakeholders: lay people (aged 23-74), different socioeconomic status and ethnicity, from urban and rural areas, invited to and not invited to screening); clinical experts (oncologists, endoscopists, gastroenterologist, gynecologists, registered nurses, psychologists) and other experts (in psychometry and IT); collaboration partners (The Swedish Association of Local Authorities and Regions - SKR, Regional Cancer Centers - RCC, National Board of Health and Welfare). No disclosed declaration of interest.
3. Design - provision of the iDA in paper format, i.e., a version with the tentative content, including the research and evidence that the iDA is based on as well as a description of the prototype development. The design of the paper version is inspired by the work of Schwartz and colleagues and will be evaluated by lay persons and experts for its content and comprehensibility regarding format (information and descriptions in text and images) and language use.
4. Alpha testing - the web-based iDA will be evaluated for its content, comprehensibility, usability and feasibility, regarding format (information and descriptions in text, spoken animations, images, audio, animated videos, certain clickable words to provide additional information, and interactive questions to help individuals to clarify and express values); language use; setting (web-based) and timing (open for anyone, link will be provided with the invitation).
5. Beta testing - the iDA will be tested in a "real world setting" and evaluated regarding format (information and descriptions in text, spoken animations, images, audio, animated videos, certain clickable words to provide additional information, and interactive questions to help individuals to clarify and express values); language use; setting (web-based) and timing (open for anyone, link will be provided with the invitation).

Data collection During the steps 3-5 data will be collected using different qualitative methods. Data regarding content, format, language use, setting and timing will be generated from focus group discussion and individual interviews. An interview guide with opened-ended questions and optional probe questions will guide the data collection. Participants will be able to choose to participate in a focus group discussion or an individual interview.

During step 3, data regarding the questions, including interactive questions (values and preferences, knowledge, and lifestyle exercises) (step 4) will be generated from concurrent cognitive interviewing where the individual gives a verbal account of their thinking while responding to the interactive questions included in the iDA. The interviews will follow a "think aloud" protocol where individuals are asked to respond to the interactive questions and encouraged to think out loud and to verbalize their thoughts while doing so. This gives an understanding on the perception of each question, as the participants work themselves through the content. In addition, probing questions will be asked when changes in appearance, such as frowning or hesitation occurs and when, or if, the session leader needs further clarification.

Data management Demographic data will be pseudo anonymized, meaning that all personal names will be removed during transcription and all participants in the studies will be given a unique code. A code list will not be established since no personal data is handled. All data will be storage in a secured facility at the Division of Nursing, Karolinska Institutet according to regulations at the university.

Data analyses Data generated from focus group discussions and individual interviews will be analyzed using descriptive and manifest content analysis. Data generated from cognitive interviews applying the "think aloud" method will be compiled and organized according to responses.

Phase 2

Procedure and outcomes After the beta-testing the iDA will be public and accessible for all who are invited and/or interested in the cancer screening programs. To be able to evaluate and develop the iDA further, topics such as digital health literacy, knowledge, values and preferences, decisional conflict, concerns, and risk awareness will be studied with self-reported questions. In addition, demographic questions such as sex, age, educational level, employment will be included as well as questions regarding lifestyle and physical activity. Usability of the iDA including the chat function, helpline, and behavior flow, i.e., how individuals navigate in the iDA will also be scrutinized.

Data collection Data will be collected through self-reported questions included in the iDA.

Data management Questionnaire data will be stored in the web-platform owned by RCC. Extracted data will be pseudo anonymized, meaning that all proper names will be removed during transcription and all participants in the studies will be given a unique code. A code list will not be established since no personal number will be handled. All data will be storage in a secured facility at the Division of Nursing, Karolinska Institutet according to regulations at the university.

Data analyses Data will be analyzed and compared using relevant descriptive and inferential statistics.

Eligibility criteria: Inclusion Criteria:

* women aged 23 -74
* men aged 60 - 74

Exclusion Criteria:

* none

Primary outcomes:
measure: Comprehensibility regarding iDA content
timeFrame: up to 10 months
measure: Usability regarding iDA format
timeFrame: up to 10 months
measure: Feasibility regarding iDA format
timeFrame: up to 10 months
Secondary outcomes:
measure: Self-reported knowledge of cancer and screening
timeFrame: up to 12 months
measure: Self-reported attitudes and preferences to cancer screening
timeFrame: up to 12 months
measure: Self-reported lifestyle behaviors
timeFrame: up to 12 months
Other outcomes:
measure: Satisfaction with the iDA and the decision
timeFrame: up to 12 months
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Kaisa Fritzell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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