Targeting Lifestyle to Improve Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16,000
- 试验地点
- 1
- 主要终点
- Change in a healthy lifestyle score
研究概览
简要总结
The goal of this study is to learn whether receiving personalized, digital lifestyle advice during colorectal cancer screening leeds to changes in lifestyle over a two-year follow-up period. Changes will be measured using a composite score including diet, alcohol consumption, physical activity, body mass index and smoking habits. The main questions it aims to answer are:
- Do participants who receive short, personalized digital feedback on their lifestyle - either once or through repeated rounds -change their lifestyle during the two-year study period, compared to those who do not receive any feedback?
- Does the inclusion of additional contact, such as telephone consultation with healthcare providers, result in further lifestyle changes?
Researchers will compare three groups which receive digital feedback at different intensities and a control group which does not get any feedback to see if lifestyle changes differ between the groups.
Participants in four different groups will fill in a digital diet and lifestyle questionnaire at the start of the study and 2-4 times after this during the following 2 years.
- Participants in three of the groups will receive a short digital feedback report on their lifestyle related to health recommendations after each completion of the questionnaire.
- One of these groups will also be offered to go through the feedback report together with a healthcare provider in a telephone call.
- This group will also receive invitations to motivational webinars every half year during the 2-year study period. The topics in the webinars address cancer preventive lifestyle.
A secondary goal of the study is to understand whether the invitation to fill in the diet and lifestyle questionnaire affects participation in colorectal cancer screening. Therefore, a fifth group of individuals invited to colorectal cancer screening but not to be invited to fill in the questionnaire will be included for extra comparison. Participation in colorectal cancer screening will be compared between this group and the four groups that are additionally invited to complete the questionnaire.
Another secondary goal is to learn which groups in the society consent to the current study. Therefore, sociodemographic characteristics will be compared between the invited individuals who consent and those who do not consent to the study.
详细描述
This is a five-armed, parallel group randomized controlled trial (RCT) among participants invited to the national colorectal cancer screening programme in Norway (ColorectalScreen Norway). The aim of the trial is to test the effect of intervention with a digital, personally tailored diet and lifestyle feedback (Digikost report) on dietary and lifestyle changes in colorectal cancer screening participants. Additionally, it is an aim to gain knowledge on feasibility and acceptability of the digital diet and lifestyle assessment and feedback at colorectal cancer screening setting.
PRIMARY AIM The main aim is to study the effect of the intervention on 2-year changes in a healthy lifestyle score.
SECONDARY AIMS:
To study:
- the effect of the intervention on 6-month changes in a healthy lifestyle score
- whether the effect on changes in the score is dependent on the intensity of the feedback
- whether introduction of the digital diet and lifestyle questionnaire at ColorectalScreen Norway affects screening participation rate
- participation rate in the digital diet and lifestyle questionnaire, and sociodemographic participant vs. non-participant characteristics
- the perceptions and accept of the digital tool in CRC screening participants.
- feasibility of conducting the study
- cancer incidence, overall mortality and cancer-specific mortality in this study population until year 2040.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invited to the first round of immunochemical faecal blood testing in the national colorectal cancer screening program via a digital platform.
排除标准
- •Not invited to the national colorectal cancer screening program.
研究组 & 干预措施
Lifestyle advice, low intensity
The participants will receive digital personally tailored diet and lifestyle advice (the Digikost report) after completion of the Digikost questionnaire at baseline.
干预措施: Digikost report baseline only (Behavioral)
Lifestyle advice, medium intensity
The participants will receive digital personally tailored diet and lifestyle advice (the Digikost report) after completion of the Digikost questionnaire at baseline and after each 6 months through the 2-year intervention period.
干预措施: Digikost report intensive (Behavioral)
Lifestyle advice, high intensity
The participants will receive digital personally tailored diet and lifestyle advice (the Digikost report) after completion of the Digikost questionnaire at baseline and after each 6 months through the 2-year intervention period. Additionally, the participants will be offered an individual telephone counselling meeting on his/her Digikost report with an advisor at baseline, as well as invited to inspirational webinars on cancer preventive lifestyle every 6 months.
干预措施: Digikost report intensive with individual counselling and webinars (Behavioral)
Control
The participants will be invited to complete the Digikost questionnaire at baseline and after 6 months and 2 years, but will not receive the Digikost report after completing the questionnaire.
Usual care
Participants will be treated only with the current standard of practice in ColorectalScreen Norway. Participants will not be informed of the trial, invited to fill in the Digikost questionnaire or receive the Digikost report.
结局指标
主要结局
Change in a healthy lifestyle score
时间窗: From baseline to the end of intervention at 24 months
Difference in a healthy lifestyle score, which consists of the 2018 WCRF/AICR Score added by smoking status for each participant, assessed at baseline and after the 2-year trial period. The healthy lifestyle score is a point score based on the participant's answers in the lifestyle questionnaire. 0-1 point is given for the grade to which the participant complies to each of the eight health recommendations: 1) normal body weight, 2) physical activity, 3) diet rich in wholegrains, vegetables, fruit and beans, 4) limited intake of 'fast foods' and other processed foods high in fat, starches or sugars, 5) limited consumption of red and processed meat, 6) limited consumption of sugar-sweetened drinks, 7) low alcohol consumption and 8) non-smoking. The healthy lifestyle score thus ranges from 0 (worst, meaning no compliance to health recommendations) to 8 points (best, meaning full compliance to health recommendations).
Change in a healthy lifestyle score
时间窗: From baseline to the end of intervention at 24 months
Difference in a healthy lifestyle score, which consists of the 2018 WCRF/AICR Score added by smoking status for each participant, assessed at baseline and after the 2-year trial period. The healthy lifestyle score is a point score based on the participant's answers in the lifestyle questionnaire. 0-1 point is given for the grade to which the participant complies to each of the eight health recommendations: 1) normal body weight, 2) physical activity, 3) diet rich in wholegrains, vegetables, fruit and beans, 4) limited intake of 'fast foods' and other processed foods high in fat, starches or sugars, 5) limited consumption of red and processed meat, 6) limited consumption of sugar-sweetened drinks, 7) low alcohol consumption and 8) non-smoking. The healthy lifestyle score thus ranges from 0 (worst, meaning no compliance to health recommendations) to 8 points (best, meaning full compliance to health recommendations).
次要结局
- Long-term total mortality(From enrollment to the end of follow-up at 16 years)
- Participation in colorectal cancer screening(Within 6 months after sending of the faecal screening test kit to the participant at first screening round)
- Completion of the Digikost questionnaire at baseline(Within 3 months after receiving the invitation to the study)
- Long-term cancer incidence(From enrollment to the end of follow-up at 16 years)
- Long-term cancer-specific mortality(From enrollment to the end of follow-up at 16 years)
- Acceptability(Baseline and 1 month)
- Feasibility of conducting the study, retention(6, 12, 18 and 24 months)
- Feasibility of conducting the study, attendance in the personal consultation telephone meetings(Baseline)
- Feasibility of conducting the study, attendance in the motivational webinars(6, 12, 18 and 24 months)
- Participation in colorectal cancer screening(Within 6 months after sending of the faecal screening test kit to the participant at first screening round)
- Completion of the Digikost questionnaire at baseline(Within 3 months after receiving the invitation to the study)
- Long-term cancer incidence(From enrollment to the end of follow-up at 16 years)
- Long-term cancer-specific mortality(From enrollment to the end of follow-up at 16 years)
- Long-term total mortality(From enrollment to the end of follow-up at 16 years)
- Acceptability(Baseline and 1 month)
- Feasibility of conducting the study, retention(6, 12, 18 and 24 months)
- Feasibility of conducting the study, attendance in the personal consultation telephone meetings(Baseline)
- Feasibility of conducting the study, attendance in the motivational webinars(6, 12, 18 and 24 months)