Trial Title:
Development, Implementation and Evaluation of an Individual Decision Aid in Swedish Cancer Screening Programs
NCT ID:
NCT05512260
Condition:
Neoplasm, Colorectal
Neoplasm, Breast
Neoplasm, Ovarian
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Ovarian Neoplasms
Conditions: Keywords:
Decision Support Techniques
Shared
Decision Making
Health promotion
Early detection of cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Individual decision aid (iDA)
Description:
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.
Arm group label:
Women aged 23 -74 and men aged 60 - 74 invited to population based cancer screening
Other name:
Decision aid in paper format
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- women aged 23 -74
- men aged 60 - 74
Exclusion Criteria:
- none
Gender:
All
Minimum age:
23 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Karolinska Institutet
Address:
City:
Huddinge
Zip:
14152
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Kaisa Fritzell, Phd
Phone:
+46812378374
Email:
kaisa.fritzell@ki.se
Contact backup:
Last name:
Anna Jervaeus, Ass professor
Phone:
+46702642039
Email:
anna.jervaeus@ki.se
Start date:
March 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Karolinska Institutet
Agency class:
Other
Collaborator:
Agency:
Jonkoping University
Agency class:
Other
Collaborator:
Agency:
Malmö University
Agency class:
Other
Collaborator:
Agency:
Umeå University
Agency class:
Other
Collaborator:
Agency:
Leiden University
Agency class:
Other
Collaborator:
Agency:
Dalarna University
Agency class:
Other
Collaborator:
Agency:
Karolinska University Hospital
Agency class:
Other
Source:
Karolinska Institutet
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512260
http://journals.library.brocku.ca/brocked/index.php/home/article/view/38
http://ipdas.ohri.ca/