Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000155897p
Ethics application status
Submitted, not yet approved
Date submitted
29/11/2020
Date registered
15/02/2021
Date last updated
15/02/2021
Date data sharing statement initially provided
15/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Kia Mataara: feasibility of remote surveillance to stay alert for lung cancer.
Scientific title
Kia Mataara: feasibility of remote surveillance for detecting symptoms of progression in patients with non-curative lung cancer.
Secondary ID [1] 302825 0
Nil known
Universal Trial Number (UTN)
U1111-1261-4287
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 319790 0
Condition category
Condition code
Cancer 317722 317722 0 0
Lung - Mesothelioma
Cancer 317723 317723 0 0
Lung - Non small cell
Cancer 317724 317724 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A custom made web based model of follow up for non curative lung cancer patients who have completed first line therapy and entering surveillance.

On completion of systemic therapy or palliative radiotherapy recruited patients will be randomised 1:1 between the standard of care (SOC) arm and the web based model. Both groups will follow the standard three monthly follow-up schedule. Both groups will be required to complete quality of life (QOL), anxiety, supportive care needs, and healthcare utilisation at all assessment points, on-line via the web based tool (Max 20 mins to complete). Patients in the trial arm will complete the web based tool at home assessing for signs of progression, at each three month assessment point or triggered by the patient. If not completed at 3 month assessment point, the patient will be prompted with an email and/or text reminder. Triage symptoms include pain, breathlessness, cough, haemoptysis, fatigue, performance status, and weight loss. Completion of this tool will trigger a response to clinical staff, via email, notifying if the patient needs to be contacted for further assessment on site. This assessment point will be in line with the patients re-staging imaging with CT. SOC arm patients will continue with onsite three monthly clinic assessments and imaging with CT. Both groups will be able to access the Cancer and Blood department between assessment points should they develop symptoms of concern. Both groups will be in surveillance until 12 months from their recruitment date. The web based tool will be manually checked alongside the clinic schedule for the trial patients, to ensure accuracy, adherence, and safety of the alert system.
Intervention code [1] 319149 0
Treatment: Other
Comparator / control treatment
The control arm is standard of care face to face in clinic, with or without imaging.
Standard of care includes: face-to-face assessment of lung cancer progression performed by oncologist, Clinical Nurse Specialist, Nurse Practitioner, or medical Registrar, involving physical exam and asking for symptoms of pain, breathlessness, cough, haemoptysis, fatigue, performance status, and weight loss, etc.
Control group
Active

Outcomes
Primary outcome [1] 325814 0
To evaluate trial processes to determine if the design of the trial is feasible and acceptable for delivering a web-based surveillance model, as determined by compliance ( measured by completion of web based surveys) and detection of progression.
Timepoint [1] 325814 0
18 months post-intervention commencement.
Secondary outcome [1] 389211 0
To describe and evaluate the patient and whanau experience of a new model for surveillance, leading to any refinement of a full trial protocol. This will be assessed through semi structured interviews.
Timepoint [1] 389211 0
6 months post the last recruited participant.
Secondary outcome [2] 391782 0
To determine if there is a reduction in health services utilisation (ED visits, hospital visits, unplanned clinic visits, GP visits, and Nurse Specialist contact). This is assessed through the Health services utilisation survey.
Timepoint [2] 391782 0
6 months post the last recruited participant.
Secondary outcome [3] 391783 0
To assess if the new model will impact on patient reported quality of life utilising the EORTC QLQ-LC13 tool.
Timepoint [3] 391783 0
6 months post the last recruited participant.
Secondary outcome [4] 391840 0
To assess if the new model will impact on patient reported anxiety utilising the Depression Anxiety Stress Scale ( DASS).
Timepoint [4] 391840 0
6 months post the last recruited participant.
Secondary outcome [5] 391841 0
To identify if the new model will impact on the proportion of 'did not attend' (DNA) visits following completion of first or subsequent lines of systemic therapy after experiencing a clinical response (or stable disease) to therapy. This will be gathered via the patient portal appointment system.
Timepoint [5] 391841 0
6 months post the last recruited participant.

Eligibility
Key inclusion criteria
Inclusion criteria
Patients over 18 years of age with confirmed non-small cell lung cancer stage 3b (non-curative intent) and stage 4, small cell lung cancer patients, and patients with mesothelioma.
Participants must have competency to sign consent.
Patients must have completed standard of care systemic treatment for their cancer.
Patients must have an ECOG performance status of 0 -3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an EGFR or ALK mutation on Tyrosine Kinase Inhibitor therapy.
Patients on systemic treatments including maintenance chemotherapy or immunotherapy.
Patients who are progressing to palliative radiotherapy treatment.
All non-English speaking patients who would require an interpreter.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of participants needed to achieve study objectives was determined through best practice from literature review of feasibility studies.

As per Medical Research Council guidelines for developing complex interventions, a feasibility study does not require formal analysis of the primary outcome. Trial processes will be evaluated to determine if progressing the intervention is feasible. Descriptive analysis of the data obtained will be conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
1/09/2022
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 23118 0
New Zealand
State/province [1] 23118 0
Auckland

Funding & Sponsors
Funding source category [1] 307247 0
University
Name [1] 307247 0
University of Auckland
Country [1] 307247 0
New Zealand
Funding source category [2] 307549 0
Charities/Societies/Foundations
Name [2] 307549 0
Cancer Research Trust NZ
Country [2] 307549 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Population Health,
University of Auckland,
Private Bag 92019
Auckland 1142
NZ
Country
New Zealand
Secondary sponsor category [1] 307865 0
Hospital
Name [1] 307865 0
Auckland City Hospital, Cancer and Blood Unit.
Address [1] 307865 0
Auckland City Hospital,
2 Park Rd,
Grafton,
Auckland, 1023
NZ
Country [1] 307865 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307342 0
Health and Disabilities Ethics Committees
Ethics committee address [1] 307342 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 307342 0
New Zealand
Date submitted for ethics approval [1] 307342 0
06/12/2020
Approval date [1] 307342 0
Ethics approval number [1] 307342 0

Summary
Brief summary
This feasibility trial will look at how follow up models could be changed to fit better alongside patient’s lives whilst still providing safe care.
Trial website
Trial related presentations / publications

Public notes

Contacts
Principal investigator
Name 106902 0
Ms Anne Fraser
Address 106902 0
Cancer and Blood Centre,
Building 8,
Auckland City Hospital,
2 Park Road,
Grafton,
Auckland, 1023
NZ.
Country 106902 0
New Zealand
Phone 106902 0
+6421840292
Fax 106902 0
Email 106902 0
[email protected]
Contact person for public queries
Name 106903 0
Ms Anne Fraser
Address 106903 0
Cancer and Blood Centre,
Building 8,
Auckland City Hospital,
2 Park Road,
Grafton,
Auckland, 1023
NZ.
Country 106903 0
New Zealand
Phone 106903 0
+6421840292
Fax 106903 0
Email 106903 0
[email protected]
Contact person for scientific queries
Name 106904 0
Ms Anne Fraser
Address 106904 0
Cancer and Blood Centre,
Building 8,
Auckland City Hospital,
2 Park Road,
Grafton,
Auckland, 1023
NZ.
Country 106904 0
New Zealand
Phone 106904 0
+6421840292
Fax 106904 0
Email 106904 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
This is not applicable for the feasibility trial work.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9858Study protocol    Once they are approved all documents will be loade... [More Details]
9859Informed consent form    Once they are approved all documents will be loade... [More Details]
9860Ethical approval    Once they are approved all documents will be loade... [More Details]



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.