Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001743156
Ethics application status
Approved
Date submitted
21/10/2019
Date registered
9/12/2019
Date last updated
23/06/2024
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
FIT for purpose: personalised surveillance colonoscopy for people at increased risk of colorectal cancer.
Scientific title
FIT for Purpose: personalised surveillance colonoscopy for people at increased risk of colorectal and the effect on resource cost to the healthcare system.
Secondary ID [1] 299495 0
None
Universal Trial Number (UTN)
Trial acronym
FIT for PURPOSE
Linked study record
This record follows on from the pilot study, ACTRN12618001277235

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer surveillance 314736 0
Colorectal Cancer 314738 0
Condition category
Condition code
Cancer 313069 313069 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 313070 313070 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Colorectal cancer (CRC) prevention programs are tailored to the degree of risk and within the Australian public health system with surveillance by colonoscopy usually reserved for those in the above average risk category. Different levels of risk, average, moderately increased and high, are recognised for population sub-groups.
All potential participants will be taken from the ‘Southern Cooperative Program for the Prevention of Colorectal Cancer’ (SCOOP) which is a clinical database which consisting of individuals with a family history of CRC or a personal history of neoplasia, and who have their surveillance colonoscopies through two South Australian public hospitals and selected private hospitals. Commencing in 1999, this program currently has 7000 people enrolled and is made up of gastroenterologists, geneticists, nurses and support administrative staff and is coordinated from the Bowel health Service (BHS) at Flinders Centre for Innovation in Cancer (FCIC), Flinders Medical Centre. SCOOP also has a research arm to help improve the program and improve patient outcomes.

It is estimated that there will be 4,500 eligible individuals from the SCOOP population, who will have a surveillance colonoscopy planned between the 2019 and 2023. Colonoscopy intervals are decided by the SCOOP team of specialists in conjunction with the National Health and Medical Research Council (NHMRC) 'Clinical practice guidelines for surveillance colonoscopy' 2018.

As part of the program, SCOOP individuals are provided with a ‘Faecal Immunochemical Test’ (FIT) kit in the interval between their 3 or 5 yearly colonoscopies. Those with a 3 year colonoscopy interval will have an offer of FIT at 1 year and those with a 5 year colonoscopy interval will have an offer of FIT at 1 year and 3 years. During this time, if they return a positive result, they will be referred for colonoscopy. Approximately 70% will complete FIT and over 50% of these will have a zero FIT result. Those with a zero FIT result, who are due for their colonoscopy within 6 months, will be invited to participate in Group 1 of the study.

As the use of FIT to predict long term development of neoplasia had only been assessed in the general population, we analysed FIT and subsequent colonoscopy outcomes within the SCOOP population. Findings were similar to that in the general population, that the lowest incidence of advanced adenoma or CRC followed a zero FIT. As adenomas grow and develop along the adenoma-carcinoma pathway, there will be an associated increase in faecal haemoglobin concentration. We propose that this information could be used to personalise surveillance colonoscopy programs. By extending the colonoscopy intervals for those with a zero FIT result, this could optimise surveillance by reducing the burden on resources without affecting the benefits.

Participants’ deemed at moderate risk for CRC, and only those who have returned a previous zero (FIT) result, will be eligible for enrolment into ‘Group 1’ of this part of the study which will be conducted as a randomised, controlled trial.
Group 1:
• All participants in Group 1 will be sent a series of six surveys, each taking approximately 10 – 20 minutes to complete. The first two surveys will be sent on consented enrolment.
SURVEY 1: Baseline/Quality of Life (QOL) Survey (A) [15 - 20 mins]
SURVEY 2: Test preference Survey No.1 - Discrete Choice Experiment (DCE) Survey-A [10 mins]

These surveys will gather information from participants regarding tests, test frequency, preferences, quality of life, and direct and indirect cost of procedures. Each survey/s will be sent with an information letter and a pre-paid return envelope and a reminder letter sent after 3 weeks if no response. There will also be a study hotline and email contact details included with the information sent to participants, so they can ask questions.

When the first two surveys are returned, or 3 months prior to their colonoscopy due date, participants will be stratified for current surveillance colonoscopy interval (i.e. 3 or 5 years). The principle medical scientist at the BHS, in conjunction with the clinical team, will randomly assign the participants (1:1) into either the intervention or control group.

ARM 1: Participants in the intervention arm will have their surveillance colonoscopy interval extended by one-third, for example: If guideline sets a 3 year surveillance interval following an advanced adenoma, the interval will be extended to 4 years. If guideline sets a 5 year surveillance interval following a non-advanced adenoma or no neoplasia, the interval will be extended to 7 years (rather than 6.7 years to simplify scheduling).
ARM 1, will also receive additional yearly FIT’s to increase patient safety, during the extended colonoscopy period. Any person returning a positive FIT will immediately be referred for a colonoscopy.

Any participants presenting with symptoms will be scheduled for colonoscopy as soon as possible regardless of trial intervention. Similarly, should a participant in the intervention arm withdraw, their colonoscopy extension interval will convert back to their original scheduled date. When the first two surveys have been returned, or 3 months prior to their colonoscopy due date, the participants will be randomised into either the control or intervention groups. A letter will then be generated and sent out to inform them of their study arm and what this will mean for them. This letter will be sent to the participant and a copy will be sent to their GP, their Specialist and the SCOOP team.

ARM 2: Participants in the control arm will receive standard clinical care, following NHMRC guidelines for colonoscopy surveillance intervals, and will have their colonoscopy scheduled by the SCOOP program.
Six weeks before colonoscopy due, in both arms, two surveys will be sent to participants.
SURVEY 3: Quality of Life (QOL) Survey (B) [10 mins]
SURVEY 4: Cost of colonoscopy Survey [15 - 20 mins]
Survey 4 will include questions relating to the personal and financial burden of having a colonoscopy, on the individual, in different circumstances (such as time off work, transport costs, carer’s costs, out-of-pocket expenses for colonoscopy, cost of adverse events). This will also help to quantify any out-of-pocket expenses to their GP, specialist, health fund, hospital or pathology. If the participant has returned a signed consent form to access Medicare claims, given at enrolment the research nurse will also contact Medicare to gather any other costs associated with the colonoscopy related fees from the patient’s Medicare claims history

One to two months after colonoscopy, a single survey will be sent to participants.
SURVEY 5: Follow-up Survey [10 - 15 mins]
This survey will investigate the satisfaction of participants with their intervention/non-intervention experience. It will include questions relating to; quality of life, satisfaction of the SCOOP program, trust in GP, health activation and fear of perceived cancer susceptibility.

Six months after colonoscopy, the final survey will be sent to participants.
SURVEY 6: Test preference survey No.2 – Discrete Choice Experiment (DCE) Survey-A
This will be the same ‘DCE’ as Survey 2. [10 mins] The data collected will be used to determine if individual preferences have changed in the study groups, over time.

Group 2:
Individuals identified from the SCOOP database who are not scheduled for a colonoscopy during the study period, will be invited to participate. Enrolees will be randomised to receive one of two different test preference surveys, either the DCE Survey-A or DCE Survey-B. This survey will gather patient perceptions of their surveillance tests and test frequency as part of the routine SCOOP surveillance management.

SINGLE SURVEY: Test preference Survey - DCE Survey-A or DCE Survey-B [10 mins]
Group 2 participants do not complete Surveys 1, 3, 4 or 5. DCE Survey-A will be the same as DCE-A in Group 1. Half of Group 2 participants will receive DCE Survey-A and half will receive DCE Survey-B.

In addition, all groups will have data collected on their existing risk factors for bowel cancer, for example, age, gender, number of previous colonoscopies, family history of colorectal cancer, personal history of adenoma’s and number of previous FIT’s.
Intervention code [1] 315747 0
Early detection / Screening
Intervention code [2] 315748 0
Behaviour
Comparator / control treatment
Participants randomised to the control arm will be made up of individuals in GROUP 1 / ARM 2, with a zero FIT in the prior 3 years. These individuals will receive the same six surveys as GROUP 1 / ARM 1 (the randomised group), however, their colonoscopy interval will not be extended but will follow recommendations as per the National Health and Medical Research Council (NHMRC) 'Clinical practice guidelines for surveillance colonoscopy' 2018 in consultation with the SCOOP specialists and geneticists.

GROUP 2 - will be made up of SCOOP individuals who are not due for colonoscopy. This group will be enrolled and asked to complete one single, Test preference Survey either, - DCE Survey-A or DCE Survey-B.
Control group
Active

Outcomes
Primary outcome [1] 321615 0
To determine the safety of extending colonoscopy schedules by one-third, in intervention arm, by including interval Faecal Immunochemical Test (FIT) as evidenced by the decreased presence of advanced neoplasia as assessed by colonoscopy.
Timepoint [1] 321615 0
Group 1: Intervention arm - Assessed 6 months post colonoscopy.
Primary outcome [2] 322133 0
Burden of having a colonoscopy as assessed by study-specific colonoscopy costing survey.
Timepoint [2] 322133 0
All participants in Group 1 only: Assessed 6 months post colonoscopy.
Secondary outcome [1] 377448 0
Participant acceptance of extending colonoscopy surveillance intervals as assessed from the Discrete Choice Experiment Surveys before and after colonoscopy.
Timepoint [1] 377448 0
All participants in Group 1 only: Assessed 6 months post colonoscopy.

Eligibility
Key inclusion criteria
Inclusion Groups 1 & 2:
• Males and females enrolled in the SCOOP clinical CRC surveillance program.
• Aged older than 18 years.
• Individuals who have either had a previous colonoscopy finding of adenoma or those with a significant family history of colorectal cancer (CRC).
• Individuals with a colonoscopy surveillance interval of at least three years.

Further inclusion for Group 1 only: (to be randomised into control or intervention arms)
• Those due for surveillance colonoscopy 2019 to 2023.
• Individuals with a zero FIT result within the last 3 years.

Further inclusion for Group 2 only: (for a single survey)
• Individuals not scheduled for a surveillance colonoscopy during the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:
• Individuals under 18 years of age.
• Individuals with a familial syndrome or inflammatory bowel disease (IBD).
• Individuals who have had bowel cancer surgery with resection.
• Individuals with the indication for colonoscopy being a positive interval FIT.
• Individuals with a colonoscopy surveillance interval less than three years.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will do simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is based on the judgement that an acceptable upper limit for advanced neoplasia incidence in the intervention is 14.2% (the usual incidence in the SCOOP clinical program). Based on our pilot data, the incidence of advanced neoplasia following the zero FIT in the control is expected to be 9.2%. A sample size of 672/group achieves 80% power with an alpha level of 0.05, to detect a 5% difference between the groups using a two-sided Z test with pooled variance. To achieve statistical power for planned regression analyses of the survey data, the sample size recommendation for stepwise regression is n=40 participants for every independent variable. Utilising 10 independent variables would require 400 completed surveys per group. This will be achieved with the planned sample size of 672/group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/12/2019
Actual
17/04/2020
Date of last participant enrolment
Anticipated
20/09/2025
Actual
Date of last data collection
Anticipated
20/09/2030
Actual
Sample size
Target
4500
Accrual to date
1366
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15021 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 15022 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [3] 15023 0
Tennyson Centre Day Hospital - Kurralta Park
Recruitment hospital [4] 15024 0
Western Hospital - Henley Beach - Henley Beach
Recruitment hospital [5] 15025 0
Flinders Private Hospital - Bedford Park
Recruitment postcode(s) [1] 28308 0
5042 - Bedford Park
Recruitment postcode(s) [2] 28309 0
5168 - Noarlunga Centre
Recruitment postcode(s) [3] 28310 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 28311 0
5022 - Henley Beach

Funding & Sponsors
Funding source category [1] 303158 0
Government body
Name [1] 303158 0
National Health and Medical Research Council - Project Grant
Country [1] 303158 0
Australia
Primary sponsor type
University
Name
Flinders University of South Australia
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 304736 0
None
Name [1] 304736 0
Address [1] 304736 0
Country [1] 304736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303718 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 303718 0
Ethics committee country [1] 303718 0
Australia
Date submitted for ethics approval [1] 303718 0
15/07/2019
Approval date [1] 303718 0
20/09/2019
Ethics approval number [1] 303718 0
307.18

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

Contacts
Principal investigator
Name 94562 0
A/Prof Erin Symonds
Address 94562 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 94562 0
Australia
Phone 94562 0
+61 8 8404 2813
Fax 94562 0
+61 8 8204 6330
Email 94562 0
[email protected]
Contact person for public queries
Name 94563 0
Jean Winter
Address 94563 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 94563 0
Australia
Phone 94563 0
+618 8 204 2814
Fax 94563 0
+61 8 8204 6330
Email 94563 0
[email protected]
Contact person for scientific queries
Name 94564 0
Erin Symonds
Address 94564 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 94564 0
Australia
Phone 94564 0
+61 8 8404 2813
Fax 94564 0
Email 94564 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
No individual data / or any raw data will be shared without appropriate future consent and/or ethical approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5407Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFIT for purpose: study protocol for a randomized controlled trial to personalize surveillance colonoscopy for individuals at elevated risk of colorectal cancer.2023https://dx.doi.org/10.1007/s00384-023-04493-8
N.B. These documents automatically identified may not have been verified by the study sponsor.