NCT06026384

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

February 27, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

August 30, 2023

Last Update Submit

September 16, 2024

Conditions

Keywords

CancerCancer LiteracyInformational InterventionHealth Communication

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes

Secondary Outcomes (1)

  • Cancer Prevention Beliefs & Cancer Information Overload

    5 minutes

Study Arms (4)

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.

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.

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.

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.

Other: animated video in narrative form

Interventions

Participants will be asked to read a text and give feedback afterwards

Non-Narrative Text

Participants will be asked to read a text and give feedback afterwards

Narrative Text

Participants will be asked to watch a video and give feedback afterwards

Non-Narrative Animation

Participants will be asked to watch a video and give feedback afterwards

Narrative Animation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Cancer Research Center

Heidelberg, 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

August 30, 2023

First Posted

September 7, 2023

Study Start

February 27, 2024

Primary Completion

April 19, 2024

Study Completion

April 19, 2024

Last Updated

September 19, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations