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Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

27. august 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3642

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Eksperimentel: Standard leaflet
A leaflet on healthy lifestyle mailed to the participant.
Adfærdsmæssigt: 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.
Ingen indgriben: Control
No contact with the participant.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
A questionnaire-based lifestyle score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Smoking status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Oslo University Hospital

Efterforskere

  • Ledende efterforsker: Paula Berstad, PhD, Cancer Registry of Norway

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2014

Primær færdiggørelse (Faktiske)

30. oktober 2016

Studieafslutning (Faktiske)

31. oktober 2018

Datoer for studieregistrering

Først indsendt

29. december 2017

Først indsendt, der opfyldte QC-kriterier

4. januar 2018

Først opslået (Faktiske)

10. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011/1272

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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