Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000293662
Ethics application status
Approved
Date submitted
7/03/2023
Date registered
17/03/2023
Date last updated
17/03/2023
Date data sharing statement initially provided
17/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing diet, exercise, sleep and other lifestyle habits in people with a known increased risk for bowel cancer and who have regular colonoscopies
Scientific title
Dietary and lifestyle behaviour and their association with risk for bowel cancer and pre-Cancerous lesions in individuals undergoing regular colonoscopies
Secondary ID [1] 309002 0
None
Universal Trial Number (UTN)
Trial acronym
RISC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 329039 0
Condition category
Condition code
Cancer 326024 326024 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 326025 326025 0 0
Epidemiology
Diet and Nutrition 326192 326192 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We propose to conduct a prospective observational study to investigate how change in diet and lifestyle patterns over time impacts the development of precancerous colorectal lesions or colorectal cancer in individuals at above average risk of colorectal cancer and undergoing a colonoscopy surveillance - the 'Southern Cooperative Program for the prevention of colorectal cancer' (SCOOP). Data regarding patients' colonoscopies will be extracted from the SCOOP database.
Participants enrolled in the SCOOP program will be invited to complete the diet and lifestyle survey over the period of three years (in years 1 (baseline survey), 2 and 3 (follow-up surveys)). The survey can be completed by the participants either online, by clicking on a provided link or scanning a QR code. It is expected that each survey will require around 40-50 minutes to be filled out. The exposure variables include:
- Dietary intake (using a validated food frequency questionnaire from the Australian Eating Survey),
- Physical activity (using the International Physical Activity Questionnaire (IPAQ-L)),
- Sleep patterns (Pittsburgh Sleep Quality Index (PSQI), Obstructive sleep apnoea screening questionnaire (OSAS), and Insomnia Severity Index questionnaire,
- Smoking status,
- Body mass index (BMI),
- Aspirin intake, and
- Comorbidities including diabetes.
Intervention code [1] 325446 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333879 0
The primary outcome of this study will be the dietary pattern that will be assessed using a validated food frequency questionnaire.
Timepoint [1] 333879 0
This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one diet survey (baseline), while those whose colonoscopies are due in two years' time will receive only two diet surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three diet surveys until the next scheduled colonoscopy.
Primary outcome [2] 334132 0
Another primary outcome of this study will be sleep quality assessed by a validated International Physical Activity Questionnaire (IPAQ-L).
Timepoint [2] 334132 0
This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one physical activity survey (baseline), while those whose colonoscopies are due in two years' time will receive only two physical activity surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three physical activity surveys until the next scheduled colonoscopy.
Primary outcome [3] 334133 0
Another primary outcome of this study will be sleep quality assessed by a validated Pittsburgh Sleep Quality Index (PSQI).
Timepoint [3] 334133 0
This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one sleep survey (baseline), while those whose colonoscopies are due in two years' time will receive only two sleep surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three sleep surveys until the next scheduled colonoscopy.
Secondary outcome [1] 418616 0
The secondary outcome of this study will be the severity of colorectal neoplasia (advanced adenoma or colorectal cancer) assessed by colonoscopy.
Timepoint [1] 418616 0
Assessed 1-2 days post any colonoscopies occurring during the 3-year observation period.
Secondary outcome [2] 419442 0
This is a composite secondary outcome for other lifestyle factors including smoking, alcohol intake and aspirin use. Smoking status, alcohol intake and aspirin use were assessed using a survey designed specifically for this study.
Timepoint [2] 419442 0
This composite outcome will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one survey (baseline), while those whose colonoscopies are due in two years' time will receive only two surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three surveys until the next scheduled colonoscopy.

Eligibility
Key inclusion criteria
Individuals enrolled to the SCOOP program (either private and public) due to having either a family history of colorectal cancer, or a personal history of adenoma or colorectal cancer, and who undergo regular surveillance colonoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to complete the survey (due to language or cognitive issues).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A health behaviour score will be derived based on individuals meeting general recommendations from published studies and national guidelines for cancer prevention with diet quality, smoking, physical activity, sleeping patter, alcohol consumption and aspirin use.

Dietary patterns will be assessed at each time point using scores that assess different aspects of a healthy diet: 1) the Mediterranean diet, and 2) the healthy eating guidelines.
Changes in each lifestyle behaviour score over time will be analysed using latent class trajectory analysis to identify trajectories of change in each behaviour score across the three time points.

Joint modelling of longitudinal and survival (time-to-event) data will be utilised to estimate the absolute risk of advanced neoplasia, for different lifestyle risk factors.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
Date of last participant enrolment
Anticipated
29/12/2024
Actual
Date of last data collection
Anticipated
29/12/2027
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24054 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 24055 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [3] 24056 0
Tennyson Centre Day Hospital - Kurralta Park
Recruitment postcode(s) [1] 39558 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 39556 0
5042 - Bedford Park
Recruitment postcode(s) [3] 39557 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 313215 0
Government body
Name [1] 313215 0
National Health and Medical Research Council
Country [1] 313215 0
Australia
Funding source category [2] 313226 0
University
Name [2] 313226 0
Flinders University
Country [2] 313226 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 314939 0
None
Name [1] 314939 0
Address [1] 314939 0
Country [1] 314939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312446 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 312446 0
Office for Research, Flinders Medical Centre, Ward 6C, Room 6A219, Flinders Drive, Bedford Park, SA 5042
Ethics committee country [1] 312446 0
Australia
Date submitted for ethics approval [1] 312446 0
07/11/2022
Approval date [1] 312446 0
06/03/2023
Ethics approval number [1] 312446 0
208.22

Summary
Brief summary
This study will explore how diet and lifestyle, as well as age and gender (and other non-modifiable risk factors), are involved in the development of bowel cancer and pre-cancerous lesions (adenomas) in people considered at above average risk for bowel cancer due to either family history of bowel cancer or prior history of colorectal adenoma.

Who is it for?
Individuals are eligible to join this study if they are aged 18 years or older, and are currently enrolled in the Southern Cooperative Program for the prevention of colorectal cancer (SCOOP) Program for a surveillance colonoscopy.

Study details:
All individuals enrolled in the SCOOP program will be invited to complete and return an online or paper survey at years 1, 2 and 3, which will ask questions on diet, exercise, sleep and other lifestyle factors.
The results from each survey and the changes in lifestyle over the 3 years will be compared to the findings at the regular surveillance colonoscopies, in particular the presence of advanced colorectal neoplasia (adenoma or cancer).

It is hoped that the results of the study will improve the understanding of the interactions between diet and lifestyle behaviour, with the non-modifiable risk factors on the development of advanced neoplasia. It is hoped that this will be useful for identifying high-risk individuals who may benefit from targeted interventions to reduce their risk of developing bowel cancer and reducing the need for unnecessary colonoscopies for lower risk patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124698 0
Dr Molla Wassie
Address 124698 0
Bowel Health Service, Level 4, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 124698 0
Australia
Phone 124698 0
+61 08 7221 8472
Fax 124698 0
Email 124698 0
molla.wassie@sa.gov.au
Contact person for public queries
Name 124699 0
Dr Molla WASSIE
Address 124699 0
Bowel Health Service, Level 4, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 124699 0
Australia
Phone 124699 0
+61 08 7221 8472
Fax 124699 0
Email 124699 0
molla.wassie@sa.gov.au
Contact person for scientific queries
Name 124700 0
Dr Molla WASSIE
Address 124700 0
Bowel Health Service, Level 4, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 124700 0
Australia
Phone 124700 0
+61 08 7221 8472
Fax 124700 0
Email 124700 0
molla.wassie@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable data from the diet and lifestyle surveys can be shared to other researchers upon a request. Ethical approval is required to access the non-identifiable clinical data.
When will data be available (start and end dates)?
Non-identifiable data from the diet and lifestyle surveys will be available after the primary analysis has been completed and the results have been published; no end date determined.
Available to whom?
The research team may provide non-identifiable diet and lifestyle survey responses to other researchers up-on approval by the Principal Investigator. A separate ethics approval is required to access the non-identifiable clinical data.
Available for what types of analyses?
Only to achieve the research questions as proposed to the Principal Investigator.
How or where can data be obtained?
Non-identifiable data may be deposited onto a publicly available data repository (as a requirement of journal publication). Other access will be subject to approval by the Principal Investigator for the survey data or the ethics committee for the clinical data. Approval from Dr Molla Wassie can be sought by emailing a short proposal to molla.wassie@sa.gov.au.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.