Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR


Registration number
ACTRN12624001466538p
Ethics application status
Submitted, not yet approved
Date submitted
18/11/2024
Date registered
17/12/2024
Date last updated
17/12/2024
Date data sharing statement initially provided
17/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising Immunotherapy for Maori with Advanced Non Small Cell Lung Cancer
Scientific title
Optimising Immunotherapy Outcomes for Maori with Advanced Non Small Cell Lung Cancer: A Mixed-Methods Study Assessing Clinical Profiles, PDL1 Testing, and Survival
Secondary ID [1] 313323 0
CTNZ-2023-05
Universal Trial Number (UTN)
U1111-1315-4224
Trial acronym
Optimise
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced non small cell lung cancer 335678 0
Condition category
Condition code
Cancer 332239 332239 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be asked to complete:
-Hua Oranga questionnaires (takes about 5 minutes to complete) - before starting immunotherapy, 3 months after commencing immunotherapy and 6 months after commencing immunotherapy
-EORTC-QLQC30 (takes about 10 minutes to complete) - before cycle 1, before cycle 2, before cycle 3, and 9 weekly until 12 months or immunotherapy discontinuation
-EORTC-QLQ-LC13 (takes about 10 minutes to complete) - before cycle 1, before cycle 2, before cycle 3, and 9 weekly until 12 months or immunotherapy discontinuation.
Participants will be asked to report immunotherapy related adverse events from time of starting immunotherapy for 12 months or immunotherapy discontinuation.

The overall duration of observation is from the time of starting immunotherapy for 12 months or until immunotherapy discontinuation.
Intervention code [1] 329904 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339901 0
Objective: Measure wellbeing on immunotherapy using a Maori-designed questionnaire, “Hua Oranga”.
Measurable primary outcome: Participants will score their wellbeing according to the four domains of Te Whare Tapa Wha: Taha Wairua (spiritual), Taha Tinana (physical), Taha Hinengaro (mental/emotional) and Taha Whanau (social). The potential responses and allocated score for each question are: Much more (+2), More (+1), No change (0), Less (-1) and Much less (-2).
Timepoint [1] 339901 0
Hua Oranga questionnaires administered prior to starting immunotherapy, then at 3 months, 6 months from start of immunotherapy
Primary outcome [2] 339991 0
Health related quality of life
Timepoint [2] 339991 0
At the time of enrolment, before cycles 1-3 then 9-weekly until treatment discontinuation or 12 months from start of immunotherapy
Primary outcome [3] 339992 0
Immune related adverse events
Timepoint [3] 339992 0
At the time of enrolment, then at each cycle until treatment discontinuation or 12 months from start of immunotherapy
Secondary outcome [1] 441870 0
Programmed Death-Ligand 1 (PD-L1),
Timepoint [1] 441870 0
PD-L1 measured at the time of enrolment
Secondary outcome [2] 441872 0
Survival
Timepoint [2] 441872 0
Participant survival will be collected at 12 months after starting immunotherapy
Secondary outcome [3] 442953 0
Health related quality of life
Timepoint [3] 442953 0
At the time of enrolment, before cycles 1-3 then 9-weekly until treatment discontinuation or 12 months from start of immunotherapy

Eligibility
Key inclusion criteria
1 Self-identified Maori Patients with a diagnosis of advanced Lung Cancer (NSCLC)
2 Prescribed first-line palliative pembrolizumab immunotherapy with or without concurrent chemotherapy
3 Aged greater than or equal to 18 years at time of signing informed consent form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Patients receiving treatment outside of the Northern Region of New Zealand

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26737 0
New Zealand
State/province [1] 26737 0

Funding & Sponsors
Funding source category [1] 317776 0
Government body
Name [1] 317776 0
Health Research Council
Country [1] 317776 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320090 0
None
Name [1] 320090 0
Address [1] 320090 0
Country [1] 320090 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316461 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316461 0
Ethics committee country [1] 316461 0
New Zealand
Date submitted for ethics approval [1] 316461 0
28/11/2024
Approval date [1] 316461 0
Ethics approval number [1] 316461 0

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

Contacts
Principal investigator
Name 137962 0
Dr Laird Cameron
Address 137962 0
University of Auckland, Private Bag 92019, Auckland 1142
Country 137962 0
New Zealand
Phone 137962 0
+64 022 014 4204
Fax 137962 0
Email 137962 0
laird.cameron@auckland.ac.nz
Contact person for public queries
Name 137963 0
Laird Cameron
Address 137963 0
University of Auckland, Private Bag 92019, Auckland 1142
Country 137963 0
New Zealand
Phone 137963 0
+64 022 014 4204
Fax 137963 0
Email 137963 0
laird.cameron@auckland.ac.nz
Contact person for scientific queries
Name 137964 0
Laird Cameron
Address 137964 0
University of Auckland, Private Bag 92019, Auckland 1142
Country 137964 0
New Zealand
Phone 137964 0
+64 022 014 4204
Fax 137964 0
Email 137964 0
laird.cameron@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.