Cancer PreventionCLARONCT06614673
Cancer Literacy as an Essential Factor for Lifestyle Behavior Changes: An Observational and Interventional Study
A study testing text in non-narrative form, text in narrative form and animated video in non-narrative form in people with Cancer Prevention, run by German Cancer Research Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Prevention
- What is being tested?
- text in non-narrative form, text in narrative form and animated video in non-narrative form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,422 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18 and 70 years old
- Being able to speak and understand german
Who cannot join
- Not being able and willing to provide informed consent and complete questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Literacy as An Essential factoR for Lifestyle behaviOr Changes: An Observational and Interventional Study
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.
Read the 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.
- Conditions
- Cancer Prevention
- Being tested
- text in non-narrative form, text in narrative form, animated video in non-narrative form, animated video in narrative form
- Keywords
- Cancer, Cancer Literacy, Informational Intervention, Health Communication
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text in non-narrative formOther
Participants will be asked to read a text and complete questionnaires
text in narrative formOther
Participants will be asked to read a text and complete questionnaires
animated video in non-narrative formOther
Participants will be asked to watch a video and complete questionnaires
animated video in narrative formOther
Participants will be asked to watch a video and complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Non-Narrative Text | Experimental | 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. Receives: Other: text in non-narrative form |
| Narrative Text | Experimental | 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. Receives: Other: text in narrative form |
| Non-Narrative Animation | Experimental | 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. Receives: Other: animated video in non-narrative form |
| Narrative Animation | Experimental | The animaion (4:04 min) is based on the text in narrative form and aims to be as fully comparable as possible. Receives: Other: animated video in narrative form |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness for cancer risk factors
Sixteen cancer risk factors from the Cancer Awareness Measure (CAM), will be assessed. Additionally, the Mythical Causes Scale of the Cancer Awareness Measure (CAM-MYCS) will be included which asks for 11 factors commonly believed to cause cancer, although there is no scientific evidence (e.g., drinking from plastic bottles). recommendations, will be assessed.
Measured: 5 Minutes
Knowledge of the European Code Against Cancer recommendations
Cancer risk factors, that are not part of the CAM, but mentioned in the ECAC4 recommendations, will be assessed.
Measured: 2 Minutes
Cancer prevention beliefs
i.e., beliefs how much cancer development is controllable by own behavior choices, will be assessed by asking for agreement with three statements that have been used in previous studies: "It seems like everything causes cancer," "There's not much you can do to lower your chances of getting cancer," and "There are so many recommendations about preventing cancer, it's hard to know which ones to follow".It has been argued that the third item is actually not targeting cancer prevention beliefs, but cancer information overload, which is why it also appears in the Cancer Information Overload Scale.
Measured: 1 Minute
Information retrieval
Information retrieval will be assessed with three items of the CAM, assessing (1) whether information on cancer prevention has ever been looked for, if yes: (2) sources of information (8 answer options), and (3) features of information sources that played a role for the decision to use information (11 answer options; if no: (2) sources of information they would use (8 answer options), and (3) features of information sources that would play a role for the decision to use information (11 answer options). Additionally, we will assess the perception of being overwhelmed by too much information on cancer prevention using the second item of the cancer prevention beliefs. Active information search will be objectively measured by offering participants informational materials on different prevention behaviors and measuring interest in downloads within the survey.
Measured: 5 Minutes
Japanese Cancer Intelligence Quotient
Two selected items from the Japanese Cancer Intelligence Quotient (JCIQ) will additionally assess participants' capability to appraise and apply informations regarding cancer risk.
Measured: 1 Minute
Secondary outcomes (3)
Health Literacy
We will assess Health Literacy using the short form of the European Health Literacy Survey HLS-Q12 , addressing self-reported competencies in accessing, understanding, appraising, and applying the information in decisions-making in healthcare, disease prevention, and health promotion.
Measured: 3 Minutes
Sociodemographic variables
age, sex, income,education, professional activity, migration background
Measured: 3 Minutes
Personal variables
cancer history, friends or family with cancer
Measured: 2 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start30 Jan 2025
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,422 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Music, Drama, and Media Hannover
- Responsible party
- Sponsor
- Investigators
- Karen Steindorf, Prof. Dr., Principal investigator, German Cancer Research CenterAlexander Haussmann, Dr., Principal investigator, German Cancer Research CenterFlorian Herbolsheimer, Dr., Principal investigator, German Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614673
- Sponsor's protocol ID
- CLARO main stuy
- Acronym
- CLARO
- Status last verified
- Feb 2025
- First submitted
- 24 Sep 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Literacy as An Essential factoR for Lifestyle behaviOr Changes: An Observational and Interventional Study
- ClinicalTrials.gov ID
- NCT06614673
- Acronym / sponsor ID
- CLARO / CLARO main stuy
- Conditions
- Cancer Prevention
- Keywords
- Cancer, Cancer Literacy, Informational Intervention, Health Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,422 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- University of Music, Drama, and Media Hannover
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non-Narrative Text | Experimental | Other: text in non-narrative formA 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. |
| Narrative Text | Experimental | Other: text in narrative formThe 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. |
| Non-Narrative Animation | Experimental | Other: animated video in non-narrative formThe 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. |
| Narrative Animation | Experimental | Other: animated video in narrative formThe animaion (4:04 min) is based on the text in narrative form and aims to be as fully comparable as possible. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18 and 70 years old
- Being able to speak and understand german
Key exclusion criteria (1 listed)
- Not being able and willing to provide informed consent and complete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| text in non-narrative formParticipants will be asked to read a text and complete questionnaires | Other | Non-Narrative Text |
| text in narrative formParticipants will be asked to read a text and complete questionnaires | Other | Narrative Text |
| animated video in non-narrative formParticipants will be asked to watch a video and complete questionnaires | Other | Non-Narrative Animation |
| animated video in narrative formParticipants will be asked to watch a video and complete questionnaires | Other | Narrative Animation |
Primary outcome
Awareness for cancer risk factors
Time frame: 5 Minutes
Sixteen cancer risk factors from the Cancer Awareness Measure (CAM), will be assessed. Additionally, the Mythical Causes Scale of the Cancer Awareness Measure (CAM-MYCS) will be included which asks for 11 factors commonly believed to cause cancer, although there is no scientific evidence (e.g., drinking from plastic bottles). recommendations, will be assessed.
Knowledge of the European Code Against Cancer recommendations
Time frame: 2 Minutes
Cancer risk factors, that are not part of the CAM, but mentioned in the ECAC4 recommendations, will be assessed.
Cancer prevention beliefs
Time frame: 1 Minute
i.e., beliefs how much cancer development is controllable by own behavior choices, will be assessed by asking for agreement with three statements that have been used in previous studies: "It seems like everything causes cancer," "There's not much you can do to lower your chances of getting cancer," and "There are so many recommendations about preventing cancer, it's hard to know which ones to follow".It has been argued that the third item is actually not targeting cancer prevention beliefs, but cancer information overload, which is why it also appears in the Cancer Information Overload Scale.
Information retrieval
Time frame: 5 Minutes
Information retrieval will be assessed with three items of the CAM, assessing (1) whether information on cancer prevention has ever been looked for, if yes: (2) sources of information (8 answer options), and (3) features of information sources that played a role for the decision to use information (11 answer options; if no: (2) sources of information they would use (8 answer options), and (3) features of information sources that would play a role for the decision to use information (11 answer options). Additionally, we will assess the perception of being overwhelmed by too much information on cancer prevention using the second item of the cancer prevention beliefs. Active information search will be objectively measured by offering participants informational materials on different prevention behaviors and measuring interest in downloads within the survey.
Japanese Cancer Intelligence Quotient
Time frame: 1 Minute
Two selected items from the Japanese Cancer Intelligence Quotient (JCIQ) will additionally assess participants' capability to appraise and apply informations regarding cancer risk.
3 secondary outcomes
Health Literacy
Time frame: 3 Minutes
Sociodemographic variables
Time frame: 3 Minutes
Personal variables
Time frame: 2 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Steindorf, Prof. Dr. principal investigator
German Cancer Research Center
Alexander Haussmann, Dr. principal investigator
German Cancer Research Center
Florian Herbolsheimer, Dr. principal investigator
German Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing text in non-narrative form, text in narrative form and animated video in non-narrative form in people with Cancer Prevention, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness for cancer risk factors (time frame: 5 Minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.