Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000340831
Ethics application status
Approved
Date submitted
21/01/2021
Date registered
25/03/2021
Date last updated
2/03/2022
Date data sharing statement initially provided
25/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the efficacy of an eHealth nutrition intervention on lifestyle-related colorectal cancer risk in patients undergoing colonoscopy.
Scientific title
An investigation of the efficacy of an eHealth nutrition intervention on lifestyle-related colorectal cancer risk in patients undergoing colonoscopy: A pilot 3-arm randomised trial.
Secondary ID [1] 303209 0
HCRA_342
Universal Trial Number (UTN)
U1111-1263-9606
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 320351 0
Condition category
Condition code
Cancer 318263 318263 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot 3-arm randomised controlled trial with the primary aim of investigating the efficacy of an enhanced eHealth nutrition intervention at reducing lifestyle-related colorectal cancer risk (as determined by the 2018 World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) score) at 3 months, within patients undergoing colonoscopy. This will be compared with the efficacy of a standard eHealth nutrition intervention, and no intervention, at reducing lifestyle-related colorectal cancer risk at 3 months, within patients undergoing colonoscopy.
Enhanced intervention group:
Enhanced group participants will receive one 30 minute online consultation via Zoom with an Accredited Practising Dietitian, and a personal nutrition report generated through completion of the online Australian Eating Survey (AES), at baseline. The one-on-one online consultation with the dietitian, using a standardised format and informed by results of the AES nutrition report, will provide participants with personalised dietary advice, strategies, and resources to improve dietary intake over 3 months, in line with the 2018 WCRF/AICR Recommendations for Cancer Prevention. The personal nutrition report will contain specific information and feedback about the participants' current dietary intake, including energy intake from core and non-core foods and drinks, macronutrient and micronutrient intake, and diet quality. The resources provided will include resources designed specifically for this study by a team of dietitians, as well as resources readily available from organisations such as the World Cancer Research Fund, Australian Government, Cancer Council, Cancer Institute NSW, and Nutrition Australia.
Standard intervention group:
Standard group participants will receive, via email, a personal nutrition report generated through completion of the AES at baseline with specific information and feedback about their current dietary intake. The standard group participants will be instructed to use the nutrition report to guide improved dietary intake over 3 months, for reduced risk of colorectal cancer.
Control group:
Participants randomised to the control group will not receive any intervention materials or education during the active intervention period. After completing the 3 month assessment, participants in the control group will receive the AES reports completed at baseline and 3 months.
Intervention code [1] 319521 0
Prevention
Intervention code [2] 319522 0
Lifestyle
Intervention code [3] 319810 0
Treatment: Other
Comparator / control treatment
The control group will be asked to complete baseline and 3-month assessments, but will not receive any intervention materials or education until after the 3-month (outcome) assessment.
Control group
Active

Outcomes
Primary outcome [1] 326246 0
The primary outcome is change in colorectal cancer risk measured using the 2018 World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) score
Timepoint [1] 326246 0
Baseline,
3 months after randomisation
Secondary outcome [1] 390727 0
Feasibility and acceptability of the study methodologies. Specifically, the following will be measured:
1. Proportion of patients completing the study - assessed by analysis of study database
Timepoint [1] 390727 0
3 months after randomisation
Secondary outcome [2] 392253 0
Feasibility of the study methodologies will be assessed by: 2. Site characteristics - assessed by collection of data such as site location, SES, number of patients/surgeons
Timepoint [2] 392253 0
3 months after randomisation
Secondary outcome [3] 392254 0
Feasibility and acceptability of the study methodologies will be assessed by: 3. Reported barriers and facilitators to implementing intervention in participating sites - assessed by staff process evaluation survey.
The process evaluation survey was designed specifically for this study.
Timepoint [3] 392254 0
3 months after randomisation
Secondary outcome [4] 392255 0
Feasibility and acceptability of the study methodologies will be assessed by: 4. Participant characteristics - assessed by study survey.
The survey was designed specifically for this study..
Timepoint [4] 392255 0
3 months after randomisation
Secondary outcome [5] 392256 0
Feasibility and acceptability of the study methodologies will be assessed by: 5. Reported barriers and facilitators to participation completion - assessed by participant process evaluation.
The process evaluation survey was designed specifically for this study.
Timepoint [5] 392256 0
3 months after randomisation

Eligibility
Key inclusion criteria
Patients aged 18 years or over scheduled to have a colonoscopy by participating surgeons at the Open Access Colonoscopy service at the Newcastle Endoscopy Clinic and the Direct Access Colonoscopy service at John Hunter Hospital and Belmont Hospital are eligible to participate in this study. Patients will be considered eligible if they can provide informed consent and also have access to a computer, tablet or smartphone with internet access, email, body weight scales and a tape measure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
27/03/2021
Actual
27/03/2021
Date of last participant enrolment
Anticipated
27/04/2021
Actual
30/11/2021
Date of last data collection
Anticipated
14/12/2021
Actual
Sample size
Target
45
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307612 0
Other Collaborative groups
Name [1] 307612 0
Hunter Cancer Research Alliance
Country [1] 307612 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Haslam
Address
ATC-205
University of Newcastle
University Dr
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 308336 0
None
Name [1] 308336 0
Address [1] 308336 0
Country [1] 308336 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307664 0
Hunter New England Human Research Ethics Committee of Hunter New England Local Health District
Ethics committee address [1] 307664 0
Ethics committee country [1] 307664 0
Australia
Date submitted for ethics approval [1] 307664 0
21/10/2019
Approval date [1] 307664 0
15/05/2020
Ethics approval number [1] 307664 0
2019/ETH13077

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108054 0
Dr Rebecca Haslam
Address 108054 0
ATC-205,
University of Newcastle,
University Dr,
Callaghan, NSW, 2308
Country 108054 0
Australia
Phone 108054 0
+61 2 4921 7862
Fax 108054 0
Email 108054 0
[email protected]
Contact person for public queries
Name 108055 0
Rebecca Haslam
Address 108055 0
ATC-205,
University of Newcastle,
University Dr,
Callaghan, NSW, 2308
Country 108055 0
Australia
Phone 108055 0
+61 2 4921 7862
Fax 108055 0
Email 108055 0
[email protected]
Contact person for scientific queries
Name 108056 0
Rebecca Haslam
Address 108056 0
ATC-205,
University of Newcastle,
University Dr,
Callaghan, NSW, 2308
Country 108056 0
Australia
Phone 108056 0
+61 2 4921 7862
Fax 108056 0
Email 108056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.