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

NCT06614673 | Completed DMC

• 1 other identifier: CLARO main stuy
• Study Type: interventional
• Target: 1,422
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Prevention

Keywords

Cancer; Cancer Literacy; Informational Intervention; Health Communication

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  1 Minute

Secondary Outcomes (3)

• Health Literacy

  3 Minutes

• Sociodemographic variables

  3 Minutes

• Personal variables

  2 Minutes

Study Arms (5)

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.

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.

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.

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.

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.

Interventions

text in non-narrative form OTHER

Participants will be asked to read a text and complete questionnaires

Non-Narrative Text

text in narrative form OTHER

Participants will be asked to read a text and complete questionnaires

Narrative Text

animated video in non-narrative form OTHER

Participants will be asked to watch a video and complete questionnaires

Non-Narrative Animation

animated video in narrative form OTHER

Participants will be asked to watch a video and complete questionnaires

Narrative Animation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 70 years old
• Being able to speak and understand german

You may not qualify if:

• Not being able and willing to provide informed consent and complete questionnaires

Sponsors & Collaborators

• German Cancer Research Center: lead
• University of Music, Drama, and Media Hannover: collaborator

Study Sites (1)

German Cancer Research Center

Heidelberg, D-69120, Germany

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Karen Steindorf, Prof. Dr.

  German Cancer Research Center

  PRINCIPAL INVESTIGATOR

• Alexander Haussmann, Dr.

  German Cancer Research Center

  PRINCIPAL INVESTIGATOR

• Florian Herbolsheimer, Dr.

  German Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: January 30, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)