Cancer PreventionCLARONCT06026384
Evaluation of Text or Animation-based Narrative and Non-narrative Interventions to Enhance Cancer Literacy: a Pilot Study (CLARO)
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 goal of this interventional pilot study is to test and evaluate different information materials created to heighten participants cancer literacy, cancer prevention beliefs, and subsequent intention for behavioral changes. 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
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 27 Feb 2024to 19 Apr 2024
- 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: Development and Evaluation of Theory Guided Narrative and Non-narrative Interventions to Enhance Cancer Literacy and Cancer Prevention Beliefs in the Population: a Pilot Study
The goal of this interventional pilot study is to test and evaluate different information materials created to heighten participants cancer literacy, cancer prevention beliefs, and subsequent intention for behavioral changes. Forty individuals, intended to cover a broad socioeconomic background, will participate in the pilot study. Based on the results of this pilot study, the information materials will be adapted for the following main study.
Read the detailed description
CLARO aims to answer the question, how information materials should be designed to strengthen optimistic beliefs on cancer prevention and to indirectly facilitate the acquisition of cancer literacy.
Four different information materials were developed and will be tested in this pilot study (2x2-design: text or animation-based / narrative or non-narrative). Participants will take part in a 30- to 40-minute survey. As part of the study, they will be randomly assigned to one of the information materials, and asked to evaluate it in depth, both quantitatively and qualitatively. The interviews will be conducted individually and face to face.
Recruitment: Two research assistants will approach potential participants at a shopping center in Heidelberg, Germany, to invite them to participate in the study. Participants will receive a leaflet with further details and contact information. Those interested will be able to participate immediately at a designated room next to the center, provided by the National Cancer Prevention Center, where all interviews will take place, or schedule an appointment via email. As an incentive, participants will receive 30€ via bank transfer upon completing the interview.
Randomization Procedure: Simple randomization - a research assistant will use an Excel spreadsheet to generate random participant codes, which will then be integrated into LimeSurvey to ensure a closed survey environment. The list of codes will be password protected and not accessible to the two research assistants who will conduct the interviews. LimeSurvey will then assign individual codes to participants. Participant codes and allocation details will then be printed on paper and placed within sealed envelopes. Interviewers will then use these envelopes to select the corresponding intervention guide.
Semi-Structured Interview: Post-intervention, participants will take part in a semi-structured interview. With participant permission, all interviews will be audio-recorded on VLC media player. The interviews will be conducted by two research assistants with a background in psychology and previous training on the interview technique.
Transcription: The audio recordings will be transcribed verbatim by the two research assistants using the MAXQDA 2022 (VERBI Software, 2021) and will be reviewed by the principal investigators for accuracy. The interviews, original transcriptions, and data analysis will be in German. All quotes will be translated into English and back-translated by two independent members of the research team to ensure that the meaning will be preserved.
By using a mixed method approach the study will combine quantitative and qualitative methods addressing the following research questions:
Quantitative:
- What is the sample's socio-demographics? (e.g. age, gender, highest educational degree, current occupational status, and income)
- Has there already been personal contact with people with cancer (e.g. through own cancer or cancer in the family)?
- What is the level of engagement in health behaviours (smoking, healthy eating, exercise, BMI)?
- How strongly are Cancer Prevention Beliefs and Cancer Information Overload represented?
- How much do the participants like the material shown? (three questions on satisfaction with the material as well as possible counter-argumentation in order to exclude distortions due to social desirability)
- Can the people in the narrative conditions identify with the characters shown?
Qualitative:
- Do the participants like the materials?
- Is there something wrong with the quality of the materials? (e.g., quality of sound \& images, presentation of animated figures, font size, readability...)
- Are the materials comprehensible?
- Is the amount of information appropriate? If not, is it too less or too much?
- Is the information given convincing?
- What are the most important insights gained from the materials? Do any of the information have novelty value?
- Are the given recommendations perceived as helpful?
- Are there ways to improve the materials?
- Might anyone feel excluded or offended by the information?
An inductive content analysis will be carried out to analyse the qualitative data obtained.
The results of the CLARO pilot study will help to improve the intervention materials that will be used for the subsequent main study.
- 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 give feedback afterwards
text in narrative formOther
Participants will be asked to read a text and give feedback afterwards
animated video in non-narrative formOther
Participants will be asked to watch a video and give feedback afterwards
animated video in narrative formOther
Participants will be asked to watch a video and give feedback afterwards
| Study group | Role | What they receive |
|---|---|---|
| Non-Narrative Text | Experimental | A short text (480 words) that deals with the preventability of cancer cases. It shows that lifestyle factors such as smoking, unhealthy diet, obesity and physical inactivity are responsible for about 40% of cancer cases. It also suggests ways to reduce the risk of cancer through behavioural changes in these areas. A special focus is on nutrition and physical activity. The text was developed on the basis of 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, except that it is built into a story. This makes the text slightly longer at 725 words. The text is about a main character and two work colleagues who share their personal experiences about nutrition and exercise. Receives: Other: text in narrative form |
| Non-Narrative Animation | Experimental | The animation with a total duration of 3:12 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 (3:45 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the materials
Participants will be asked questions regarding the material presented (qualitatively and quantitatively) covering general satisfaction, comprehensibility, persuasion, affective reactions and potential ways to improve the material.
The quantitative items regarding general satisfaction and counter-argumentation are rated on a 5-point Likert scale ranging from 1 = "Do not agree at all" to 5 = "Fully agree" with higher scores indicating higher satisfaction with the material as well as higher counter-argumentation.
Identification with characters will be measured using one item asking "What was the extent to which you could identify with the main characters in the animation?". Participants in the narrative condition will rate this question per character on a scale of 1 (very low) to 10 (very high), so higher scores indicate higher identification.
Measured: 20 minutes
Secondary outcomes (1)
Cancer Prevention Beliefs & Cancer Information Overload
Participans will be assessed 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". Participants will indicate agreement on a 4-point likert scale ranging from 1 = "strongly agree" to 4 = "strongly disagree".
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start27 Feb 2024
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
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
- 41 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
- NCT06026384
- Sponsor's protocol ID
- CLARO Pilot
- Other IDs
- 70114759
- Acronym
- CLARO
- Status last verified
- Feb 2024
- First submitted
- 30 Aug 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Theory Guided Narrative and Non-narrative Interventions to Enhance Cancer Literacy and Cancer Prevention Beliefs in the Population: a Pilot Study
- ClinicalTrials.gov ID
- NCT06026384
- Acronym / sponsor ID
- CLARO / CLARO Pilot
- Conditions
- Cancer Prevention
- Keywords
- Cancer, Cancer Literacy, Informational Intervention, Health Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- University of Music, Drama, and Media Hannover
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 7 Sep 2023 (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 goal of this interventional pilot study is to test and evaluate different information materials created to heighten participants cancer literacy, cancer prevention beliefs, and subsequent intention for behavioral changes. Forty individuals, intended to cover a broad socioeconomic background, will participate in the pilot study. Based on the results of this pilot study, the information materials will be adapted for the following main study.
Detailed description
CLARO aims to answer the question, how information materials should be designed to strengthen optimistic beliefs on cancer prevention and to indirectly facilitate the acquisition of cancer literacy.
Four different information materials were developed and will be tested in this pilot study (2x2-design: text or animation-based / narrative or non-narrative). Participants will take part in a 30- to 40-minute survey. As part of the study, they will be randomly assigned to one of the information materials, and asked to evaluate it in depth, both quantitatively and qualitatively. The interviews will be conducted individually and face to face.
Recruitment: Two research assistants will approach potential participants at a shopping center in Heidelberg, Germany, to invite them to participate in the study. Participants will receive a leaflet with further details and contact information. Those interested will be able to participate immediately at a designated room next to the center, provided by the National Cancer Prevention Center, where all interviews will take place, or schedule an appointment via email. As an incentive, participants will receive 30€ via bank transfer upon completing the interview.
Randomization Procedure: Simple randomization - a research assistant will use an Excel spreadsheet to generate random participant codes, which will then be integrated into LimeSurvey to ensure a closed survey environment. The list of codes will be password protected and not accessible to the two research assistants who will conduct the interviews. LimeSurvey will then assign individual codes to participants. Participant codes and allocation details will then be printed on paper and placed within sealed envelopes. Interviewers will then use these envelopes to select the corresponding intervention guide.
Semi-Structured Interview: Post-intervention, participants will take part in a semi-structured interview. With participant permission, all interviews will be audio-recorded on VLC media player. The interviews will be conducted by two research assistants with a background in psychology and previous training on the interview technique.
Transcription: The audio recordings will be transcribed verbatim by the two research assistants using the MAXQDA 2022 (VERBI Software, 2021) and will be reviewed by the principal investigators for accuracy. The interviews, original transcriptions, and data analysis will be in German. All quotes will be translated into English and back-translated by two independent members of the research team to ensure that the meaning will be preserved.
By using a mixed method approach the study will combine quantitative and qualitative methods addressing the following research questions:
Quantitative:
- What is the sample's socio-demographics? (e.g. age, gender, highest educational degree, current occupational status, and income)
- Has there already been personal contact with people with cancer (e.g. through own cancer or cancer in the family)?
- What is the level of engagement in health behaviours (smoking, healthy eating, exercise, BMI)?
- How strongly are Cancer Prevention Beliefs and Cancer Information Overload represented?
- How much do the participants like the material shown? (three questions on satisfaction with the material as well as possible counter-argumentation in order to exclude distortions due to social desirability)
- Can the people in the narrative conditions identify with the characters shown?
Qualitative:
- Do the participants like the materials?
- Is there something wrong with the quality of the materials? (e.g., quality of sound \& images, presentation of animated figures, font size, readability...)
- Are the materials comprehensible?
- Is the amount of information appropriate? If not, is it too less or too much?
- Is the information given convincing?
- What are the most important insights gained from the materials? Do any of the information have novelty value?
- Are the given recommendations perceived as helpful?
- Are there ways to improve the materials?
- Might anyone feel excluded or offended by the information?
An inductive content analysis will be carried out to analyse the qualitative data obtained.
The results of the CLARO pilot study will help to improve the intervention materials that will be used for the subsequent main study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Narrative Text | Experimental | Other: text in non-narrative formA short text (480 words) that deals with the preventability of cancer cases. It shows that lifestyle factors such as smoking, unhealthy diet, obesity and physical inactivity are responsible for about 40% of cancer cases. It also suggests ways to reduce the risk of cancer through behavioural changes in these areas. A special focus is on nutrition and physical activity. The text was developed on the basis of the Protection Motivation Theory. |
| Narrative Text | Experimental | Other: text in narrative formThe narrative text contains the same information as the non-narrative text, except that it is built into a story. This makes the text slightly longer at 725 words. The text is about a main character and two work colleagues who share their personal experiences about nutrition and exercise. |
| Non-Narrative Animation | Experimental | Other: animated video in non-narrative formThe animation with a total duration of 3:12 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 (3:45 min) is based on the text in narrative form and aims to be as fully comparable as possible. |
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 give feedback afterwards | Other | Non-Narrative Text |
| text in narrative formParticipants will be asked to read a text and give feedback afterwards | Other | Narrative Text |
| animated video in non-narrative formParticipants will be asked to watch a video and give feedback afterwards | Other | Non-Narrative Animation |
| animated video in narrative formParticipants will be asked to watch a video and give feedback afterwards | Other | Narrative Animation |
Primary outcome
Satisfaction with the materials
Time frame: 20 minutes
Participants will be asked questions regarding the material presented (qualitatively and quantitatively) covering general satisfaction, comprehensibility, persuasion, affective reactions and potential ways to improve the material. The quantitative items regarding general satisfaction and counter-argumentation are rated on a 5-point Likert scale ranging from 1 = "Do not agree at all" to 5 = "Fully agree" with higher scores indicating higher satisfaction with the material as well as higher counter-argumentation. Identification with characters will be measured using one item asking "What was the extent to which you could identify with the main characters in the animation?". Participants in the narrative condition will rate this question per character on a scale of 1 (very low) to 10 (very high), so higher scores indicate higher identification.
1 secondary outcome
Cancer Prevention Beliefs & Cancer Information Overload
Time frame: 5 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 19 Sep 2024.
- 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 19 Sep 2024. 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?
Satisfaction with the materials (time frame: 20 minutes). 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 19 Sep 2024.