Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000444482
Ethics application status
Approved
Date submitted
31/03/2025
Date registered
13/05/2025
Date last updated
13/05/2025
Date data sharing statement initially provided
13/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact and outcomes of using the Cancer Whiri model of care to support Maori patients on their cancer journey
Scientific title
Cancer Whiri II: Extending the Pathway. The co-design and testing of a Cancer Whiri model of care to support Maori patients on their whole cancer journey: the impact on outcomes for them and their whanau/family
Secondary ID [1] 314049 0
Health Research Council Registration number 23/775
Universal Trial Number (UTN)
U1111-1320-9211
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 336793 0
Condition category
Condition code
Cancer 333287 333287 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Cancer Whiri
Why: to assess health and well being needs of the participant and support these needs.
Cancer Whiri 1 is a completed research project that used similar co-design and methodology to Cancer Whiri 2. Cancer Whiri I (Titled: Pandemic system redesign to maximise Maori health gains) was not registered as a clinical trial. The Health Research Council reference is 20/1389. A published abstract for the results is linked below with further publications still in draft to be submitted.
https://nzmj.org.nz/media/pages/journal/vol-137-no-1607/proceedings-of-the-waikato-clinical-campus-research-seminar-thursday-31-october-2024/84bd5ced15-1733948956/6826.pdf

What: We plan to partner with a range of stakeholders to co-design the WHA (whanau hauora assessment) tool, used as part of the Whiri approach, to assess and meet needs for Maori adults referred with suspicion of cancer. The comprehensive well being screening and support tool, the WHA, will have follow-up protocols for each question and will be administered by a trained Maori navigator to support whanau to access a range of services, including providing help when possible. For example, checking general practice (GP) enrolment and if not enrolled supporting enrolment, asking about smoking and supporting smoking cessation, healthy homes check (asking a few questions about whether the home is warm, dry, insulated and not overcrowded), cancer screening and immunisations as well as other identified relevant topics. These are yet to be determined through the co-design process.

Co-design phase: Co-design methods will include group wananga and one-on-one hui; with approximately 30-40 people in total. We will invite Cancer Whiri I pilot patients and whanau participants to participate. Along with people with cancer and their whanau, whanau haua Maori (people with lived experience of disability), and co-design partners from Whiri I.
The Cancer Whiri 1 co-design patients (there were 4) were part of wananga /group discussions to inform the Cancer Whiri model of care. These were informal group discussions and feedback that was not recorded/transcribed but rather used to help refine and inform the model of care. The co-design group patients did not go through full informed consent processes as we did not collect any research or personal information from these patients. In Cancer Whiri 2, we do plan to go through full informed consent processes and collect personal information along with recording the co-design sessions. There are 3 co-design patients from Cancer Whiri I who have verbally agreed to be involved in the current study along with one of the research assistants on the project, who is no longer working for our organisation. These are all Maori women aged 45-60 who have gone through a cancer journey in the past.
The co-design process is expected to take 3-6 months in duration.
It will be conducted by research team members. This includes the named investigators and the research officer employed on the project and a project manager to be employed in Auckland. Some of these sessions will be one-one-one discussions and other will be group discussions.
The methods used in Cancer Whiri 1 included the following examples: The sessions began by patients describing their own cancer journey's and the things that helped them along the way. Also in the first session, there was a drawing of the timeline of the steps in a cancer journey on the whiteboard (from referral from the GP up until treatment began) and having this on handouts. The group would go through the cancer pathway steps to discuss any of the inequity gaps for Maori that need to be addressed by the model and come up with ideas together in discussions of practical or operational things that could be done. In later sessions a draft of the model was presented back to the group for them to provide feedback or advice on any changes or additions. These sessions included the project lead (Maori public health physician and highly experienced in co-design) and named investigator (a haematology cancer doctor) who were very familiar with Waikato and New Zealand cancer data, rates, the cancer pathway and faster cancer treatment data. Also included were the research programme manager (an NI) along with the research officer employed on the project. All members of the research team had family members that had been impacted by cancer and so could also speak from personal experiences at times. This same group will also be facilitating co-design sessions in the present study (Cancer Whiri II).
Participants will decide how many sessions they will participate in. For the one-on-one sessions, it is likely only 1 session will be required. For the co-design group discussions, there may be up to 2-3 sessions of group discussions. These will occur over a period of up to 6 months. It will depend on how the model of care looks and whether participants feel it is to their satisfaction or not (the co-design group will decide when they are happy with the model of care). One-on-one sessions will last for approximately up to 1-hour, but may only take 30-minutes. Group discussions will be conducted for 2-3 hours with breaks and food included for lunch (or afternoon/morning tea, as appropriate). All participants not employed by the host organisation will receive koha/vouchers for their contribution to the study, for each session. All sessions will be audio recorded and transcribed. Written notes will also be taken by the researcher present at the co-design group and on-on-one sessions.

Co-design of the WHA
All components of the WHA tool will be co-designed. We will start with a draft tool that was used in Cancer Whiri I study and the tool will be updated, added to or parts removed as advised by the co-design partners. The length and estimated duration going through the tool will be assessed once there is a complete draft of the WHA, and before the pilot commences. If it is deemed too long then some parts may be removed or suggested as optional time permitting. It is the intention of the WHA to be patient directed and so any parts of the tool that patients do not want to complete will not be asked and they can also decide the order in which they go through the assessment - they will be provided with a list of the main sections covered in the tool to make an informed choice.

We will invite new partners including; clinicians and ward staff, cancer Clinical Nurse Specialists, clinical psychologist (cancer services), Te Aho o Te Kahu (Cancer Control Agency) members, Hei Ahuru Mowai (Maori Cancer Leadership Aotearoa), primary care providers, and cancer organisations (The Cancer Society, Leukaemia & Blood Cancer).
Some co-design partners will have one-on-one hui to discuss and co-design relevant aspects of the programme with a researcher. We will also hold wananga (10-15 people), and smaller discussion groups (e.g. 4-7) for particular areas of the programme, i.e. primary care may include 3 Maori GPs, and 2 consumers. There will be as many sessions as required. We had 12 for Cancer Whiri I (plus feedback from at least 10 other hui in related studies) and expect at least double this number for Whiri II because the pathway is longer and there are two sites. Discussions/ wananga will use methods used in Cancer Whiri I; using tikanga Maori, whanaungatanga, an overview of the project and issues and discussion where Maori and whanau voice is privileged.
We will use purposive sampling where individuals and groups are invited (via email or in person), based on their unique characteristics, circumstances, and experiences (Bryman, 2008). Co-design partners will be sent the Co-design Partners PISCF. This includes seeking consent to take notes during the meeting/wananga, and possibly digitally recording the session if mutually agreed it is appropriate to do so. Any notes or quotes will be discussed for confirmation and any further comment. Co-design partners may choose to be identified in the research findings. Otherwise, their identity will not be shared with anyone other than the research team. A free, prior, informed consent process will be followed. This process will be done in accordance with Kaupapa Maori principles and practices of whakawhanaungatanga, tino rangatiratanga, koha, manaakitanga, and kanohi ki te kanohi. Key to this is treating all participants with dignity and respect.

The pilot/intervention - who provided: The WHA assessment will be administered by a trained Maori navigator to support whanau to access a range of services where needed. Training will for the navigator will include a combination of in-house training on the WHA assessment and other Te Whatu Ora Waikato or Ministry training associated with specific topics in the hauora assessment. For example, how to screen for family violence (Te Whatu Ora family violence coordinator runs 1 day training sessions on this), and the Ministry of Health NZ online smoking cessation training (1 hour). In-house training will include going over and role playing completing a hauora assessment with wider research team members (at least 3 practice sessions, approximately 1 hour each) and practicing with other members of the Maori Health service (at least 2, for approximately 30-40 min each time). There will also be a 1 hour session with the director of Tikanga (Maori protocol expert) or with a delegated person, to learn about approaching and engaging with Maori whanau and participants. For any clinical unmet needs identified, the navigator will refer to the Whiri clinical team which includes a senior nurse or CNS and a Maori GP for clinical oversight. The nurse will support co-morbidity management and enhanced support along the early cancer pathway. The Whiri CNS will develop a plan to manage comorbidities and enhance care along the cancer pathway. As part of this plan the CNS will identify issues and come up with solutions involving individuals, whanau and providers. The CNS will ensure that relevant pilot and secondary care providers are on the same page. S/he will also link services that maybe required during the pathway. The Whiri CNS will continue to support patients until it is no longer required, or they are discharged or self-discharge from the pathway. S/he will ensure handover to relevant providers at this stage. The specifics on the Whiri clinical component and the establishment of the pathways needed will also be developed during the co-design process. If the research ends before treatment ends, patient participants will be referred to the cancer equity nurse for support at Waikato and Auckland Hospitals.

Mode of delivery: the assessment will be delivered face to face with an individual and their whanau will be present if they wish.
Where: assessments will take place primarily at patient homes but may occur in or outpatient clinic appointments or other location at the hospital or community as arranged with the participant. The Whiri clinical team will primarily contact and support participants virtually, and where required the nurse may attend oncology appointments with participants.
When and how much: the assessment will be conducted once at the time of recruitment. It is expected to take between 40-60 minutes to complete.
Modifications: the assessment will be co-designed from the start and it is expected that where needed modifications will be made to the intervention throughout the course of the trial. This will be informed by the research and co-design groups.
Intervention code [1] 330631 0
Lifestyle
Intervention code [2] 330632 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340867 0
Description/number of wellbeing needs of participants, determined by the responses in the WHA specifically designed for this study.
Timepoint [1] 340867 0
Taken at the time of doing the WHA assessment with the participant, on the day. If the assessment is incomplete at that time, it should be completed within 14 days of starting the assessment.
Secondary outcome [1] 445315 0
Ratings on the patient experience survey, as determined by the responses in the survey specifically designed for this study.
Timepoint [1] 445315 0
Taken at the time of doing the patient experience survey with the participant, on the day. The survey should be completed within 2 weeks of discharge from WHIRI programme/intervention.
Secondary outcome [2] 446088 0
Hyper/hypotension
Timepoint [2] 446088 0
Taken at baseline
Secondary outcome [3] 446089 0
Diabetes
Timepoint [3] 446089 0
Taken at baseline (at the time of consent) and within 30-days after discharge from the WHIRI programme
Secondary outcome [4] 446090 0
Renal impairment
Timepoint [4] 446090 0
Taken at baseline (at the time of consent) and within 30-days after discharge from the WHIRI programme
Secondary outcome [5] 446091 0
COPD or lung health
Timepoint [5] 446091 0
Taken at baseline (at the time of consent) and within 30-days after discharge from the WHIRI programme
Secondary outcome [6] 446092 0
Smoking status
Timepoint [6] 446092 0
Taken at baseline (at the time of consent) and within 30-days after discharge from the WHIRI programme
Secondary outcome [7] 446093 0
Clinic attendance
Timepoint [7] 446093 0
Taken within 30-days after discharge from the WHIRI programme
Secondary outcome [8] 446094 0
Declining cancer care
Timepoint [8] 446094 0
Taken within 30-days after discharge from the WHIRI programme
Secondary outcome [9] 446095 0
Cholesterol
Timepoint [9] 446095 0
Taken at baseline (at the time of consent) and within 30-days after discharge from the WHIRI programme
Secondary outcome [10] 446096 0
First contact
Timepoint [10] 446096 0
Taken within 30-days after discharge from the WHIRI programme
Secondary outcome [11] 446097 0
Polypharmacy
Timepoint [11] 446097 0
Taken at baseline (at time of consent) within 30-days after discharge from the WHIRI programme
Secondary outcome [12] 446098 0
Medication adherence
Timepoint [12] 446098 0
Taken at baseline (at the time of consent) and within 30-days after discharge from the WHIRI programme
Secondary outcome [13] 446099 0
Feasibility of the co-designed WHIRI programme to use for Maori Cancer patients for the whole pathway
Timepoint [13] 446099 0
Measured at the completion of the WHIRI pilot

Eligibility
Key inclusion criteria
For pilot participants
- Identify as Maori
- aged 18 years and above
- be referred to the Regional referral centre Te Whatu Ora Waikato for a suspicion of cancer
- be a Waikato region resident.
- whanau/family members of patients consented into the study
OR
- Identify as Maori
- aged 18 years and above
- be referred to the Regional referral centre Te Toka Tumai/ Auckland for a suspicion of cancer
- be an Auckland region resident.
- whanau/family members of patients consented into the study

For co-design participants
- someone who has personal or professional experience with the tertiary healthcare pathway and/or community health services in New Zealand
Including:
• Patients or whanau with experience of the Cancer Care pathway
• Any staff from a health provider or community service that actively works to provide support to whanau either undergoing investigation for potential cancer, or with a cancer diagnosis, or needing other health or well being support
• Maori Clinicians or those who work in oncology at Auckland or Waikato hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For pilot participants
• Patients who have already entered the study
• Patients who are not eligible for publicly funded health care in New Zealand

For co-design participants
- people who do not have personal or professional experience with the tertiary healthcare pathway and/or community health services in New Zealand

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
n/a

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment outside Australia
Country [1] 26926 0
New Zealand
State/province [1] 26926 0
Waikato and Auckland

Funding & Sponsors
Funding source category [1] 318555 0
Government body
Name [1] 318555 0
Health Research Council of New Zealand
Country [1] 318555 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato Hospital, Te Whatu Ora Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 320953 0
Hospital
Name [1] 320953 0
Te Toka Tumai Auckland Hospital
Address [1] 320953 0
Country [1] 320953 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317155 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 317155 0
Ethics committee country [1] 317155 0
New Zealand
Date submitted for ethics approval [1] 317155 0
23/01/2025
Approval date [1] 317155 0
07/03/2025
Ethics approval number [1] 317155 0
Ethics reference: 2025 EXP 21353

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

Contacts
Principal investigator
Name 140186 0
Dr Nina Scott
Address 140186 0
Maori Health, Hockin Level 1, Waikato Hospital, Pembroke St, Private Bag 3200, Hamilton 3240
Country 140186 0
New Zealand
Phone 140186 0
+6421907513
Fax 140186 0
Email 140186 0
[email protected]
Contact person for public queries
Name 140187 0
Amy Jones
Address 140187 0
Maori Health, Hockin Level 1, Waikato Hospital, Pembroke St, Private Bag 3200, Hamilton 3240
Country 140187 0
New Zealand
Phone 140187 0
+64273439715
Fax 140187 0
Email 140187 0
[email protected]
Contact person for scientific queries
Name 140188 0
Amy Jones
Address 140188 0
Maori Health, Hockin Level 1, Waikato Hospital, Pembroke St, Private Bag 3200, Hamilton 3240
Country 140188 0
New Zealand
Phone 140188 0
+64 273439715
Fax 140188 0
Email 140188 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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 10 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Please contact study manager Amy Jones
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24584Study protocol    Cancer WHIRI II_PROTOCOL V1 FINAL.docx
24585Ethical approval    Ethics approval letter attached CW2 ethics approval-53737.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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