Cancer Literacy as an Essential Factor for Lifestyle Behavior Changes: An Observational and Interventional Study

NCT ID: NCT06614673

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-Narrative Text

A short text, consisting of 504 words, that addresses the preventability of cancer cases. It highlights the impact of lifestyle factors such as smoking, unhealthy diet, obesity, and physical inactivity, which contribute to approximately 40% of cancer cases. The text also provides recommendations for reducing the risk of cancer through behavioral changes in these areas, with a particular emphasis on nutrition and physical activity. The text was developed based on the Protection Motivation Theory.

Group Type EXPERIMENTAL

text in non-narrative form

Intervention Type OTHER

Participants will be asked to read a text and complete questionnaires

Narrative Text

The narrative text contains the same information as the non-narrative text, but it is presented as a story. It is slightly longer at 737 words and features a main character and two work colleagues sharing their personal experiences about nutrition and physical activity.

Group Type EXPERIMENTAL

text in narrative form

Intervention Type OTHER

Participants will be asked to read a text and complete questionnaires

Non-Narrative Animation

The animation with a total duration of 3:35 min is based on the text in non-narrative form and aims to be as fully comparable as possible.

Group Type EXPERIMENTAL

animated video in non-narrative form

Intervention Type OTHER

Participants will be asked to watch a video and complete questionnaires

Narrative Animation

The animaion (4:04 min) is based on the text in narrative form and aims to be as fully comparable as possible.

Group Type EXPERIMENTAL

animated video in narrative form

Intervention Type OTHER

Participants will be asked to watch a video and complete questionnaires

Control Group

After completing all the questionnaires (i.e. after completing participation in the study), the control group will be given the opportunity to view all the information material that was created.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

text in non-narrative form

Participants will be asked to read a text and complete questionnaires

Intervention Type OTHER

text in narrative form

Participants will be asked to read a text and complete questionnaires

Intervention Type OTHER

animated video in non-narrative form

Participants will be asked to watch a video and complete questionnaires

Intervention Type OTHER

animated video in narrative form

Participants will be asked to watch a video and complete questionnaires

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Music, Drama, and Media Hannover

UNKNOWN

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karen Steindorf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

German Cancer Research Center

Alexander Haussmann, Dr.

Role: PRINCIPAL_INVESTIGATOR

German Cancer Research Center

Florian Herbolsheimer, Dr.

Role: PRINCIPAL_INVESTIGATOR

German Cancer Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

German Cancer Research Center

Heidelberg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLARO main stuy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.