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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
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 29, 2017
    Last Updated
    August 27, 2019
    Sponsor
    Oslo University Hospital
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    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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