01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The Norwegian dietary guidelines and colorectal cancer survival (CRC-NORDIET) study: a food-based multicentre randomized controlled trial
- Zeitschrift:
- BMC Cancer > Ausgabe 1/2017
Electronic supplementary material
Background
Objectives
Methods and Design
Study design
Patients and eligibility
Inclusion criteria
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Primary adenocarsinoma colorectal cancer (ICD-10 C18-C20):
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C18 Malignant neoplasm of colon
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C18.0 Caecum
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C18.1 Appendix
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C18.2 Ascending colon
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C18.3 Hepatic flexure
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C18.4 Transverse colon
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C18.5 Splenic flexure
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C18.6 Descending colon
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C18.7 Sigmoid colon (sigmoid (flexure)
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C18.8 Overlapping lesion of colon
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C18.9 Colon, unspecified
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C19 Malignant neoplasm of rectosigmoid junction
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C20 Malignant neoplasm of rectum
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TNM stage I-III
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Age 50–80 years old
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Exclusion criteria
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Colorectal adenoma, carcinoid, abdominal carcinomatosis or sarcoma
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Unable to read and understand Norwegian
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Unable to perceive information and understand the intervention as such due to dementia or altered mental status
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Unable to follow the dietary intervention due to medical/clinical conditions e.g. total parental nutrition, permanently institutionalized
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Participation in another study in conflict with the intention of the CRC-NORDIET study
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Recruitment and randomization
Intensive period of intervention
Baseline (at study centre)
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1 month (at home)
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3 months (at home)
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6 months (at study centre)
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9 months (at home)
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12 months (at study centre)
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Nutritional counselling
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Face to face individual
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Phone call
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Phone call
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Face to face individual
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Phone call
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Face to face individual
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Free-of-charge food
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Delivered at the visit
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Home delivery
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Delivered at the visit
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Home
delivery
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Delivered at the visit
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Information/
courses
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Folder with information on the study and the study instruments
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Inspiration day and Cooking course
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Discount card
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Discount card (25% discount on healthy foods)
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CRC-NORDIET Webpage/
e-mail
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Login-restricted webpage access and e-mail communication
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Physical activity
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Access to free training facilities (“Pusterommet”)
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Reports from non-biological measurements
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Reports sent to the patients after every visit
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Baseline (at study centre)
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1–12 months (1, 3, and 9 months at home, 6 and 12 months at the study centre)
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Information/
courses
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Folder with information on the study
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Inspiration day
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Physical activity
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Access to free training facilities (“Pusterommet”)
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Reports from non-biological measurements
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Reports sent to the patients after every visit
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Group A: diet intervention
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Drinks (e.g. coffee, black tea)
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Fruits and vegetables (e.g. onions, broccoli, tomatoes, carrots, pomegranates, garlic, oranges, olives)
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Berries (e.g. blueberries/bilberries, blackberries, and raspberries)
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Nuts (e.g. walnuts, almonds, and hazel nuts)
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Herbs and spices (e.g. thyme, oregano, clove, cinnamon, and rosemary)
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Whole grain (e.g. barley)
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Miscellaneous (dark chocolate)
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Coffee
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Fruits and vegetables (e.g. tomatoes, carrots, dog rose)
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Nuts (e.g. walnuts)
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Berries (e.g. strawberries, blueberries/bilberries, and blackberries)
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Whole grains
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Herbs and spices (e.g. thyme, oregano, and rosemary)
Intervention strategies
Group B: control group
Moderate intervention during maintenance period (year 2–15)
Instruments
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Time points
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2, 4, 6, 8, 9, 11, 12, 13, 14 years
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3, 5, 7, 10, 15 years
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Dietary counselling at study centre (Group A)
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X
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Dietary counselling by telephone (Group A)
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X
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X
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Inspiration day with extended diet session (Group A)
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X
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X
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CRC-NORDIET Website/e-mail (Group A)
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X
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X
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Reports from non-biological measurements (Group A and B)
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X
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Assessment of primary outcomes
Outcome
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Instrument
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5 years after baseline
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10 years after baseline
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15 years
after baseline
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DFS
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Colorectal Cancer Registry of Norway, Cancer Registry of Norway, Cause of Death Registry in Norway, Norwegian Patient Registry, Norwegian Prescription Database
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X
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X
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X
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OS
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Cause of Death Registry in Norway
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X
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X
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X
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Questionnaires, biological samplings and measurements
Demographic information
Assessment of dietary intake
Assessment of physical activity and function
Assessment of nutritional status
Anthropometric measurements
Body composition analysis
Blood pressure
Biobank
Oral glucose tolerance test
Health related quality of life and fatigue
Assessment of new morbidity of diet-related chronic diseases and adverse events
Sample size
Calculation for primary outcomes
Reduction in mortality by intervention
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Survival rates in the control group
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Primary outcome
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20%
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25%
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30%
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n (HR)
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n (HR)
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n (HR)
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DFS
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5 years
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320 (0.753)
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190 (0.696)
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140 (0.641)
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0.59
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10 years
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240 (0.716)
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140 (0.655)
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110 (0.597)
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0.41
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15 years
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180 (0.680)
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120 (0.616)
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90 (0.557)
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0.29
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OS
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5 years
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390 (0.767)
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250 (0.712)
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160 (0.658)
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0.68
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10 years
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280 (0.732)
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180 (0.673)
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130 (0.616)
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0.48
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15 years
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210 (0.695)
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140 (0.632)
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100 (0.574)
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0.34
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