Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001321538
Ethics application status
Approved
Date submitted
16/10/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Gut Survey: Gathering patients’ and caregivers’ opinions and preferences for clinical care provided after a diagnosis of oesophageal, stomach or bowel cancer
Scientific title
The Gut Survey: Evaluating patients’ and caregivers’ previous clinical care experiences and their opinions of blood biomarker tests to monitor oesophageal, gastric and colorectal cancers
Secondary ID [1] 313203 0
None
Universal Trial Number (UTN)
Trial acronym
GUTSY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer 335496 0
Oesophageal cancer 335497 0
Stomach cancer 335498 0
Condition category
Condition code
Oral and Gastrointestinal 332055 332055 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 332056 332056 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 332057 332057 0 0
Oesophageal (gullet)
Cancer 332058 332058 0 0
Stomach
Public Health 332059 332059 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will use surveys to assess the unmet clinical care needs and testing preferences of individuals who have had treatment for a gastrointestinal cancer (oesophageal, stomach or bowel cancer), and a nominated caregiver/support person of their choosing. Eligible patients will be identified from the gastrointestinal cancer clinics at approved study sites (Flinders Medical Centre, Noarlunga Health Service, and The Queen Elizabeth Hospital), where patients will be invited to complete two surveys, one provided at the time of study invitation and the other provided within one month of receiving a response to the first survey (each survey taking approximately 15 minutes to complete). Patients will also be asked to nominate a caregiver or support person of their choosing to complete a single survey (taking approximately 30 minutes to complete). Survey questions will measure participants’ opinions of their previous clinical care experiences, and will assess their preferences for blood biomarker tests to monitor gastrointestinal cancers, along with psychosocial impacts (e.g., fear of cancer recurrence), health beliefs, preferences for treatment decision making, and trust in their cancer care team.
Intervention code [1] 329778 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339657 0
Participants’ unmet clinical care needs.
Timepoint [1] 339657 0
For patients and caregivers: Assessed at a single timepoint during study enrolment.
Primary outcome [2] 339658 0
Participants’ preferences for a blood test to monitor gastrointestinal cancers.
Timepoint [2] 339658 0
For patients: Assessed at a single timepoint approximately one month after receiving a response to the first survey. For caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [1] 440780 0
Participants' trust in different test types and their previous use of tests.
Timepoint [1] 440780 0
For patients: Assessed at a single timepoint approximately one month after receiving a response to the first survey. For caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [2] 440781 0
Participants' health beliefs regarding different types of tests.
Timepoint [2] 440781 0
For patients: Assessed at a single timepoint approximately one month after receiving a response to the first survey. For caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [3] 440782 0
Patients’ preferences for treatment decision making.
Timepoint [3] 440782 0
For patients: Assessed at a single timepoint approximately one month after receiving a response to the first survey. For caregivers: N/A.
Secondary outcome [4] 440974 0
Patients' trust in their cancer care team.
Timepoint [4] 440974 0
For patients: Assessed at a single timepoint approximately one month after receiving a response to the first survey. For caregivers: N/A.
Secondary outcome [5] 440976 0
Participants' fear of cancer recurrence.
Timepoint [5] 440976 0
For patients and caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [6] 440977 0
Participants' post-traumatic stress symptoms.
Timepoint [6] 440977 0
For patients and caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [7] 440978 0
Participants' general anxiety symptoms.
Timepoint [7] 440978 0
For patients and caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [8] 440979 0
Participants' depressive symptoms.
Timepoint [8] 440979 0
For patients and caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [9] 440980 0
Participants' scan-related anxiety ("scanxiety").
Timepoint [9] 440980 0
For patients and caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [10] 440981 0
Participants' resilience.
Timepoint [10] 440981 0
For patients and caregivers: Assessed at a single timepoint during study enrolment.
Secondary outcome [11] 440982 0
Caregivers' quality of life.
Timepoint [11] 440982 0
For patients: N/A. For caregivers: Assessed at a single timepoint during study enrolment.

Eligibility
Key inclusion criteria
Eligible participants include those who are: 1) over 18 years of age; 2) willing to complete up to two surveys; 3) have a previous diagnosis of oesophageal, stomach or bowel cancer OR 4) have cared for or supported someone who has a history of one of the cancers named above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will not be considered for study enrolment if they are: 1) patients in the palliative phase of their cancer; OR 2) unable to provide informed consent or complete the survey.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analyses will be performed using appropriate statistical analysis software (e.g., Jamovi, SPSS). Survey responses will be summarised using descriptive statistics and multiple imputation may be used to generate values for missing survey data. Both univariate and multivariable generalised linear modelling will be performed to explore if any sociodemographic, clinical, or psychological variables are predictive of participants’ clinical care needs, as well as their acceptability of a blood test to monitor gastrointestinal cancers. Parametric and/or non-parametric tests will be used dependent on whether the survey data distribution is determined to be normal or non-normal, respectively. Statistical significance will be determined at p values <0.05 and effect sizes will be estimated using odds ratios with a 95% confidence interval.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27243 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 27244 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [3] 27245 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 43324 0
5042 - Bedford Park
Recruitment postcode(s) [2] 43325 0
5168 - Noarlunga Centre
Recruitment postcode(s) [3] 43326 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 317647 0
Government body
Name [1] 317647 0
National Health and Medical Research Council
Country [1] 317647 0
Australia
Primary sponsor type
University
Name
Flinders University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 319963 0
None
Name [1] 319963 0
Address [1] 319963 0
Country [1] 319963 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316346 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 316346 0
Ethics committee country [1] 316346 0
Australia
Date submitted for ethics approval [1] 316346 0
03/07/2024
Approval date [1] 316346 0
23/09/2024
Ethics approval number [1] 316346 0
136.24

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

Contacts
Principal investigator
Name 137602 0
A/Prof Erin Symonds
Address 137602 0
Bowel Health Service, Level 3 Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 137602 0
Australia
Phone 137602 0
+61 8 8404 2813
Fax 137602 0
Email 137602 0
[email protected]
Contact person for public queries
Name 137603 0
Maddison Dix
Address 137603 0
Bowel Health Service, Level 3 Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 137603 0
Australia
Phone 137603 0
+61 8 7421 9957
Fax 137603 0
Email 137603 0
[email protected]
Contact person for scientific queries
Name 137604 0
Maddison Dix
Address 137604 0
Bowel Health Service, Level 3 Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 137604 0
Australia
Phone 137604 0
+61 8 7421 9957
Fax 137604 0
Email 137604 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The research team may provide de-identified data to other researchers after receiving approval from the Principal Investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Only de-identified data will be shared with other researchers. This will include individual participant data of survey responses, as reported in publication(s). No clinically identifiable information will be shared.

What types of analyses could be done with individual participant data?
• Only to achieve the aims as proposed to and approved by the Principal Investigator.

When can requests for individual participant data be made (start and end dates)?
From:
After main results publication. No end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access will be subject to approval from the Principal Investigator. Approval from A/Prof Erin Symonds can be sought by emailing a research proposal to [email protected].

Are there extra considerations when requesting access to individual participant data?
No


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.