Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

Study Overview
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Brief Summary
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This randomized controlled trial aims to investigate the effect of an individually tailored lifestyle feedback letter and a leaflet on lifestyle in the context of sigmoidoscopy screening.

Detailed Description
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Cancer screening may be used as a teachable moment for healthy lifestyle behaviours. This study aims to investigate the effect of minimal, but individually tailored lifestyle advice and a standard leaflet on healthy lifestyle given at a colorectal cancer screening context on one-year changes in these behaviours in a population-based sample of men and women. Individuals invited to sigmoidoscopy screening in the piloting of Norwegian Bowel Cancer Screening are additionally invited to this lifestyle intervention study. Changes in lifestyle are measured by a brief lifestyle questionnaire administered at prescreening and after one year. The intervention to the intervention arms is given after completion of the prescreening lifestyle questionnaire.

Official Title
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A Randomized Trial of Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

Conditions
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Body Weight, Lifestyle, Diet Habit, Smoking Cessation, Physical Activity, Alcohol Drinking

Intervention / Treatment
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* Behavioral: Individually tailored lifestyle feedback
* Behavioral: Standard leaflet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invited to sigmoidoscopy screening in the Norwegian Bowel Cancer Screening Pilot Study Exclusion Criteria: Excluded from sigmoidoscopy screening due to medical reasons, previous colorectal cancer diagnosis, relocating out of the screening municipalities or previous colonoscopy in the last 12 months.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individually tailored lifestyle feedback<br>Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant. | Behavioral: Individually tailored lifestyle feedback<br>* The written, standardized individually tailored lifestyle feedback includes feedback on consumption of fruit, berries and vegetables and alcohol, physical activity, smoking and body mass index.<br>Behavioral: Standard leaflet<br>* The leaflet is The Norwegian Cancer Society's one-page information brochure on healthy lifestyle behaviours for low cancer risk, including non-smoking, healthy body weight, physical activity, diet, moderate alcohol consumption, moderate sun exposure etc.<br>|
| Experimental: Standard leaflet<br>A leaflet on healthy lifestyle mailed to the participant. | Behavioral: Standard leaflet<br>* The leaflet is The Norwegian Cancer Society's one-page information brochure on healthy lifestyle behaviours for low cancer risk, including non-smoking, healthy body weight, physical activity, diet, moderate alcohol consumption, moderate sun exposure etc.<br>|
| No Intervention: Control<br>No contact with the participant. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A questionnaire-based lifestyle score | A score variable ranging from 0 (least favorable) to 6 (most favorable), calculated as the sum of self-reported favorable lifestyle factors assessed by a questionnaire; non-smoking (1 score point), body mass index less than 25 kg/m2 (1 score point), a minimum of seven physical activity sessions of 30 minutes per a week (1 score point), a maximum of four dinner servings of red and processed meat per a week (1 score point), a minimum of three servings of fruit, berries and vegetables per a day (0.5 score point) and a minimum of one serving of fatty fish per a week (0.5 score points) | One year; from pre-screening until one year after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking status | Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire | One year; from pre-screening until one year after | 
| Alcohol consumption | Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire | One year; from pre-screening until one year after | 
| Physical activity | Self-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire | One year; from pre-screening until one year after | 
| Consumption of fruit and vegetables | Self-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire | One year; from pre-screening until one year after | 
| Body weight | Self-reported body weight (whole kilograms), assessed by a questionnaire | One year; from pre-screening until one year after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyle intervention, Diet, Smoking cessation, Physical activity, Alcohol, Body mass index, colorectal cancer screening, sigmoidoscopy