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Trial Title:
Cancer Literacy As an Essential Factor for Lifestyle Behavior Changes: an Observational and Interventional Study
NCT ID:
NCT06614673
Condition:
Cancer Prevention
Conditions: Keywords:
Cancer
Cancer Literacy
Informational Intervention
Health Communication
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
text in non-narrative form
Description:
Participants will be asked to read a text and complete questionnaires
Arm group label:
Non-Narrative Text
Intervention type:
Other
Intervention name:
text in narrative form
Description:
Participants will be asked to read a text and complete questionnaires
Arm group label:
Narrative Text
Intervention type:
Other
Intervention name:
animated video in non-narrative form
Description:
Participants will be asked to watch a video and complete questionnaires
Arm group label:
Non-Narrative Animation
Intervention type:
Other
Intervention name:
animated video in narrative form
Description:
Participants will be asked to watch a video and complete questionnaires
Arm group label:
Narrative Animation
Summary:
The CLARO study aims to examine the most effective way to design information materials
that can strengthen optimistic beliefs about cancer prevention and improve cancer
literacy indirectly. Around 5,800 participants from the Stuttgart region in Germany will
be contacted by postal mail and invited to take part in an online survey using the
LimeSurvey®-System. Four different types of information materials, tested in a pilot
study (2x2-design: text or animation-based / narrative or non-narrative), will be
included in the survey. Participants will be randomly assigned to one of the four
interventions or to a control group that will not receive any intervention (the control
group will have access to all information materials after having completed the whole
questionnaire). As an incentive, participants will receive 10€ via bank transfer upon
completing the survey.
Detailed description:
The online survey can be accessed through a unique link or QR code and is compatible with
various electronic devices such as PCs, tablets, and smartphones. Reminders will be sent
after one month and two months. Participants can also request a paper questionnaire if
needed. We will make an effort to contact more people from districts with lower
socioeconomic status. Furthermore, the study cover letter will disclose that all study
participants will receive ten euros if they provide their bank details after completion
of the study questionnaires. Participants will be redirected via a link to another
LimeSurvey for this purpose.
The online questionnaire will be divided into two parts. The first part, which will
assess sociodemographic information, questions on cancer literacy, and more, will take
about 10 minutes. Subsequently, participants will be randomly assigned to one of the four
intervention groups or to a control group. Reading or viewing the information materials
will take about 5 minutes. In the second part of the questionnaire, participants will
evaluate the information materials, assess intentions for health behaviors, and have
access to further information materials (approximately 5 minutes). The control group will
have access to all information materials after having completed the whole questionnaire.
The primary aims of the observational part of the study are, first, to assess levels of
cancer literacy in a representative German population, including all four cancer literacy
domains (i.e., access, understand, appraise, apply). Second, this study part aims to
identify sociodemographic groups (e.g., defined by age, sex, sociodemographic background,
educational level) showing significantly lower levels of cancer literacy. As a secondary
aim, the observational part of the study determines levels of cancer prevention behaviors
in Germany (i.e., smoking status, diet, alcohol consumption, and physical activity).
The primary aim of the interventional part of the study is to assess the effects of
different health communication strategies (i.e., text or animation in non-narrative or
narrative style) on the primary outcome of cancer prevention beliefs. The secondary aim
is to examine health communication strategies in their effect on secondary outcomes,
i.e., intention for cancer prevention behaviors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Between 18 and 70 years old
- Being able to speak and understand german
Exclusion Criteria:
- Not being able and willing to provide informed consent and complete questionnaires
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
December 2024
Completion date:
March 2025
Lead sponsor:
Agency:
German Cancer Research Center
Agency class:
Other
Collaborator:
Agency:
University of Music, Drama, and Media Hannover
Agency class:
Other
Source:
German Cancer Research Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06614673