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

German Cancer Research Center

Status: Completed

Conditions: Cancer Prevention

Treatments: Other: animated video in non-narrative form; Other: animated video in narrative form; Other: text in narrative form; Other: text in non-narrative form

Study type: Interventional

Funder types: Other

Identifiers

NCT06614673

CLARO main stuy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,422 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,422 participants in 5 patient groups

Non-Narrative Text

Experimental group

Description:

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.

Treatment:

Other: text in non-narrative form

Narrative Text

Experimental group

Description:

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.

Treatment:

Other: text in narrative form

Non-Narrative Animation

Experimental group

Description:

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.

Treatment:

Other: animated video in non-narrative form

Narrative Animation

Experimental group

Description:

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

Treatment:

Other: animated video in narrative form

Control Group

No Intervention group

Description:

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.