Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000100796
Ethics application status
Approved
Date submitted
23/12/2021
Date registered
24/01/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Gathering patients’, carers’ and doctors’ opinions on the use of blood tests to monitor the treatment of oesophageal, stomach and bowel cancers- a qualitative study
Scientific title
A qualitative study to evaluate patients’, carers’ and doctors’ opinions on blood biomarker tests to monitor the treatment of oesophageal, gastric and colorectal cancers
Secondary ID [1] 306106 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer 324775 0
Stomach cancer 324776 0
Oesophageal cancer 324777 0
Condition category
Condition code
Oral and Gastrointestinal 322228 322228 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 322387 322387 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 322388 322388 0 0
Oesophageal (gullet)
Cancer 322389 322389 0 0
Stomach
Public Health 322390 322390 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
Over recent years there has been an increase in the development of new blood tests for the use in detection, monitoring and surveillance of cancers. It is important that acceptability to cancer surveillance with blood biomarkers is identified through a range of approaches. This research will use focus groups to identify acceptability of blood biomarker tests, as well as other methods such as CT scans and colonoscopy, for use in cancer surveillance. This will be done with: (1) people who have undergone treatment for the different cancers (oesophageal, stomach or bowel), (2) their carers or support persons, and (3) clinicians who are involved in cancer treatment.

Individuals who have undergone treatment for oesophageal, stomach, or bowel cancer during the prior three years will be identified via the gastrointestinal cancer clinic lists at the Flinders Medical Centre for invitation into a focus group, along with their nominated support person. Clinicians will be invited into the focus groups through an information session or email. Prior to the focus group, consented individuals will be contacted by a member of the research team to collect baseline characteristics (e.g., demographics, details about cancer stage and treatment, roles covered as a support person or clinician).
Focus groups will be held in person at Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, or via a web-based option such as Zoom or Microsoft TEAMS. The focus group will take approximately 45 minutes and each participant will only participate in one focus group. Separate focus groups will be held for patients, carers and clinicians, with approximately 6 people invited into each session. The focus groups will be led by facilitators (study researchers) who will follow a semi-structured format and follow the discussion guide which has been designed specifically for this study. Topics in the discussion guide include knowledge, trust and acceptability of different tests for monitoring cancer treatment, and for providing post-cancer surveillance, with a particular focus on blood-based tests.
Intervention code [1] 322522 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329997 0
Knowledge of clinical tests to monitor cancer treatment and surveillance, which will be assessed using qualitative, audio recorded, 45-minute focus group discussions which will be semi-structured based upon a study-specific discussion guide.
Timepoint [1] 329997 0
1 month after recruitment (during the focus group)
Primary outcome [2] 329998 0
Trust in clinical tests to monitor cancer treatment and surveillance, which will be assessed using qualitative, audio recorded, 45-minute focus group discussions which will be semi-structured based upon a study-specific discussion guide.
Timepoint [2] 329998 0
1 month after recruitment (during the focus group)
Primary outcome [3] 329999 0
Experience of clinical tests to monitor cancer treatment and surveillance, which will be assessed using qualitative, audio recorded, 45-minute focus group discussions which will be semi-structured based upon a study-specific discussion guide.
Timepoint [3] 329999 0
1 month after recruitment (during the focus group)
Secondary outcome [1] 404537 0
Perspectives on specific blood-based biomarker, which will be assessed using qualitative, audio recorded, 45-minute focus group discussions which will be semi-structured based upon a study-specific discussion guide.
Timepoint [1] 404537 0
1 month after recruitment (during the focus group)

Eligibility
Key inclusion criteria
Participants, carers and clinicians who fit the following criteria will be invited into the study:
1) be over 18 years of age and be willing to participate in a focus group either in person at the Flinders Centre for Innovation in Cancer (Bedford Park, South Australia), or be able to participate in group discussion via a web-based format e.g. Microsoft Teams or Zoom.
2) have undergone treatment (within the previous 3 years) of stomach, oesophageal or bowel cancer, OR have supported someone who has a history of one of these cancers, OR work in a clinical role providing clinical care for patients with these cancers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if:
1) They are in the palliative phase of their cancer;
2) Have any underlying conditions (e.g., anxiety/depression) where discussing their diagnosis and treatment might exacerbate any symptoms.
Participants, carers or clinicians will be excluded if:
1) They have a perceived or actual conflict of interest relating to any blood biomarker tests.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
After each focus group, the co-facilitators will determine the relevant themes arising from the focus group. This may be related to processes used during the group, dynamics within and across the group and any other relevant observations. The qualitative data will be analysed using content analysis (with the software NVivo) by following a process of searching text, for recurring words, concepts or ideas. For >80% power in detecting a clinically important mean difference for each of the 3 groups, the aim is to recruit 48 patients, 48 carers, and 24 clinicians.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/04/2022
Actual
27/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
96
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21418 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 36310 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 310461 0
Government body
Name [1] 310461 0
National Health and Medical Research Council
Country [1] 310461 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
1 Flinders Drive, Bedford Park, 5042, South Australia
Country
Australia
Secondary sponsor category [1] 311609 0
None
Name [1] 311609 0
None
Address [1] 311609 0
None
Country [1] 311609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310092 0
Southern Adelaide Clinical Health Human Research Ethics Committee
Ethics committee address [1] 310092 0
Ethics committee country [1] 310092 0
Australia
Date submitted for ethics approval [1] 310092 0
Approval date [1] 310092 0
07/12/2021
Ethics approval number [1] 310092 0
227.21

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

Contacts
Principal investigator
Name 116438 0
A/Prof Erin Symonds
Address 116438 0
Bowel Health Service, Level 3 Flinders Centre for Innovation in Cancer, 1 Flinders Drive, Bedford Park, South Australia 5042
Country 116438 0
Australia
Phone 116438 0
+61 08 8404 2813
Fax 116438 0
Email 116438 0
[email protected]
Contact person for public queries
Name 116439 0
Erin Symonds
Address 116439 0
Bowel Health Service, Level 3 Flinders Centre for Innovation in Cancer, 1 Flinders Drive, Bedford Park, South Australia 5042
Country 116439 0
Australia
Phone 116439 0
+61 08 8275 1075
Fax 116439 0
Email 116439 0
[email protected]
Contact person for scientific queries
Name 116440 0
Erin Symonds
Address 116440 0
Bowel Health Service, Level 3 Flinders Centre for Innovation in Cancer, 1 Flinders Drive, Bedford Park, South Australia 5042
Country 116440 0
Australia
Phone 116440 0
+61 08 8275 1075
Fax 116440 0
Email 116440 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?

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.