Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396029
• Other study ID #: 2011/1272
• Status: Completed
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: October 31, 2018

Study information

• Verified date: August 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3642
• Est. completion date: October 31, 2018
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Body Weight
• Colorectal Neoplasms
• Diet Habit
• Lifestyle
• Physical Activity
• Smoking Cessation

Intervention

Behavioral:
• Individually tailored lifestyle feedback
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.
• Standard leaflet
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Smoking status	Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire	One year; from pre-screening until one year after
Secondary	Alcohol consumption	Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire	One year; from pre-screening until one year after
Secondary	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
Secondary	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
Secondary	Body weight	Self-reported body weight (whole kilograms), assessed by a questionnaire	One year; from pre-screening until one year after