Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

August 27, 2019 updated by: Paula Berstad, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3642

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individually tailored lifestyle feedback
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
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.
Behavioral: 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.
Experimental: Standard leaflet
A leaflet on healthy lifestyle mailed to the participant.
Behavioral: 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.
No Intervention: Control
No contact with the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A questionnaire-based lifestyle score
Time Frame: One year; from pre-screening until one year after
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
Time Frame: One year; from pre-screening until one year after
Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire
One year; from pre-screening until one year after
Alcohol consumption
Time Frame: One year; from pre-screening until one year after
Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire
One year; from pre-screening until one year after
Physical activity
Time Frame: One year; from pre-screening until one year after
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
Time Frame: One year; from pre-screening until one year after
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
Time Frame: One year; from pre-screening until one year after
Self-reported body weight (whole kilograms), assessed by a questionnaire
One year; from pre-screening until one year after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Paula Berstad, PhD, Cancer Registry of Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

October 30, 2016

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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