ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Colorectal Cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Public Health

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]

Early detection / Screening

Intervention code [2]

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]

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]

Group 1: Intervention arm - Assessed 6 months post colonoscopy.

Primary outcome [2]

Burden of having a colonoscopy as assessed by study-specific colonoscopy costing survey.

Timepoint [2]

All participants in Group 1 only: Assessed 6 months post colonoscopy.

Secondary outcome [1]

Participant acceptance of extending colonoscopy surveillance intervals as assessed from the Discrete Choice Experiment Surveys before and after colonoscopy.

Timepoint [1]

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?

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)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment hospital [2]

Noarlunga Health Service - Noarlunga Centre

Recruitment hospital [3]

Tennyson Centre Day Hospital - Kurralta Park

Recruitment hospital [4]

Western Hospital - Henley Beach - Henley Beach

Recruitment hospital [5]

Flinders Private Hospital - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Recruitment postcode(s) [2]

5168 - Noarlunga Centre

Recruitment postcode(s) [3]

5037 - Kurralta Park

Recruitment postcode(s) [4]

5022 - Henley Beach

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council - Project Grant

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University of South Australia

Address

Sturt Rd, Bedford Park SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Southern Adelaide Local Health Network
Office for Research
Level 6 / Room 6A - 219
Flinders Medical Centre
Bedford Park, 5042
South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/07/2019

Approval date [1]

20/09/2019

Ethics approval number [1]

307.18

Summary

Brief summary

This study will investigate the effect of personalised surveillance colonoscopy of people at increased risk of colorectal cancer on the health system.

All participants invited into this study will be individuals who are enrolled in the 'Southern Co-operative Program for the Prevention of Colorectal Cancer', SCOOP (a colonoscopy surveillance program in Adelaide).
Eligibility will be for those 18 years or older, who have either had a previous colonoscopy finding of adenoma or who have a significant family history of colorectal cancer (CRC) and with a colonoscopy surveillance interval of at least three years. Those who have done a 'faecal immunochemical test' (FIT) and had a zero result for the prior three years will be eligible for Group 1.

This group will be asked to complete a series of 6 questionnaires over a 3 - 5 year period, before and after colonoscopy. These questionnaires, will ask participants about their quality of life, general health and well-being, satisfaction with their current surveillance program and their personal preferences for surveillance strategies. There will also be questions about how much it costs individuals to have a colonoscopy, including out-of-pocket expenses and time spent. The costing information will be linked to the Medicare costs of colonoscopy procedure. There will also be a follow-up questionnaire at the end.
Half of this group will have their surveillance colonoscopy as scheduled by the SCOOP team of doctors and the other half will have their colonoscopy extended by one-third. To ensure safety, this group will have extra FIT kits sent out annually and will be booked for an urgent colonoscopy if returning a positive result. A negative result will mean it is safe to continue the extended colonoscopy interval.
People who are not due for colonoscopy during the 5 year study period, will be invited to join Group 2 and asked to complete a single survey about perceptions of their surveillance tests and test frequency as part of the routine SCOOP surveillance management.

This study will determine if surveillance colonoscopy intervals can be safely extended based on FIT results for individuals at increased risk of CRC within an established CRC surveillance program. This will become the world’s first study to determine the safety, cost effectiveness & patient acceptance of extending colonoscopy surveillance intervals based on interval FIT results.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Erin Symonds

Address

Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042

Country

Australia

Phone

+61 8 8404 2813

Fax

+61 8 8204 6330

[email protected]

Contact person for public queries

Name

Dr Jean Winter

Address

Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042

Country

Australia

Phone

+618 8 204 2814

Fax

+61 8 8204 6330

[email protected]

Contact person for scientific queries

Name

A/Prof Erin Symonds

Address

Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042

Country

Australia

Phone

+61 8 8404 2813

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
5407	Ethical approval			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	FIT for purpose: study protocol for a randomized controlled trial to personalize surveillance colonoscopy for individuals at elevated risk of colorectal cancer.	2023	https://dx.doi.org/10.1007/s00384-023-04493-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically