Tailored Written Lifestyle Feedback in Colorectal Cancer Screening
Primary Purpose
Lifestyle, Diet Habit, Smoking Cessation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individually tailored lifestyle feedback
Standard leaflet
Sponsored by
About this trial
This is an interventional prevention trial for Lifestyle focused on measuring Lifestyle intervention, Diet, Smoking cessation, Physical activity, Alcohol, Body mass index, colorectal cancer screening, sigmoidoscopy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Individually tailored lifestyle feedback
Standard leaflet
Control
Arm Description
Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.
A leaflet on healthy lifestyle mailed to the participant.
No contact with the participant.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Smoking status
Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire
Alcohol consumption
Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire
Physical activity
Self-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire
Consumption of fruit and vegetables
Self-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire
Body weight
Self-reported body weight (whole kilograms), assessed by a questionnaire
Full Information
NCT ID
NCT03396029
First Posted
December 29, 2017
Last Updated
August 27, 2019
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03396029
Brief Title
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening
Official Title
A Randomized Trial of Tailored Written Lifestyle Feedback in Colorectal Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
October 30, 2016 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle, Diet Habit, Smoking Cessation, Physical Activity, Alcohol Drinking, Body Weight
Keywords
Lifestyle intervention, Diet, Smoking cessation, Physical activity, Alcohol, Body mass index, colorectal cancer screening, sigmoidoscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
A computer programme designed by the research team IT developer carried out the randomization. The recruitment and the contact between the investigators and the participants was mailed. There was no face-to-face contact.
Allocation
Randomized
Enrollment
3642 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individually tailored lifestyle feedback
Arm Type
Experimental
Arm Description
Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.
Arm Title
Standard leaflet
Arm Type
Experimental
Arm Description
A leaflet on healthy lifestyle mailed to the participant.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No contact with the participant.
Intervention Type
Behavioral
Intervention Name(s)
Individually tailored lifestyle feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard leaflet
Intervention Description
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.
Primary Outcome Measure Information:
Title
A questionnaire-based lifestyle score
Description
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)
Time Frame
One year; from pre-screening until one year after
Secondary Outcome Measure Information:
Title
Smoking status
Description
Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire
Time Frame
One year; from pre-screening until one year after
Title
Alcohol consumption
Description
Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire
Time Frame
One year; from pre-screening until one year after
Title
Physical activity
Description
Self-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire
Time Frame
One year; from pre-screening until one year after
Title
Consumption of fruit and vegetables
Description
Self-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire
Time Frame
One year; from pre-screening until one year after
Title
Body weight
Description
Self-reported body weight (whole kilograms), assessed by a questionnaire
Time Frame
One year; from pre-screening until one year after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Berstad, PhD
Organizational Affiliation
Cancer Registry of Norway
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Tailored Written Lifestyle Feedback in Colorectal Cancer Screening
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