Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000222347
Ethics application status
Approved
Date submitted
7/02/2017
Date registered
10/02/2017
Date last updated
10/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Cancer support programmes for Maori whanau
Scientific title
Cancer support programmes for Maori whanau. Designing, implementing and evaluating a sustainable supportive cancer care programme for Maori whanau.
Secondary ID [1] 291099 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
supportive cancer care for Maori whanau 301915 0
Condition category
Condition code
Public Health 301577 301577 0 0
Health service research
Cancer 301603 301603 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) To develop a Maori cancer support whanau programme including a framework of sustainability as a core component. This includes designing the materials and activities, and additionally interviewing key informants to inform the programme sustainability component. Key informants will be experts who have extensive experience in the area of research, policy, management level, and/or cancer service provision across the primary, secondary and palliative care cancer interface. The interviews will focus on positive features of cancer support programmes and the types of organisational processes (including community, workforce and policy environments) that are consistent with a sustainable Maori cancer support whanau programme.
(2) To implement a Maori cancer support whanau programme. The programme sessions are delivered in groups. The six key areas to be covered in the programme include: knowledge of cancer; treatment; oncology services; support options; confidence building; coping and planning for the future. The facilitators will be from the communities of each of the cases. The programmes will run continuously over a one year period and participants will be invited onto the programme as they are identified by each MHP organisation. Groups will be run once/fortnight (once/month over winter). TThe duration of each session is not yet known and will vary depending on the needs and preferences of the group, however it is likely that each session will involve an hour of information sharing and another hour of whakawhanaungatanga (connection) and hakare (eating together). The locations of the support groups are yet to be finalised, but are likely to be at local marae or other community meeting places where whanau will feel comfortable.
(3) To evaluate the effectiveness of a Maori cancer support whanau programme. This phase involves interviews with whanau who have taken part in the programme. Informed consent will be obtained before interviews take place. Interviews will be held at locations where whanau are comfortable such as their homes or marae. They will be undertaken face to face with a trained researcher from the study team. Programme documents will also be examined including panui, information kits and any other material generated from the programme,
Intervention code [1] 297088 0
Other interventions
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300984 0
Composite primary outcome. After 1 year, a sample of whanau (10 from each case) from each of the programme sites will be interviewed to explore the challenges and benefits following implementation of the programme. With informed consent, semi structured interviews will be undertaken with participants, conducted by a trained researcher who is part of the study team
Whanau will be asked how they came to attend the programme and how participation has affected their lives, as well as their families. For example, aspects of participating in the programme such as gaining strength from sharing and learning with other whanau will be explored. Additionally, participants will be asked if they have shared their knowledge with others in their whanau and community, and whether this has encouraged participation in, for example, screening programmes.
Timepoint [1] 300984 0
Participants will be interviewed one year after the programme is implemented.
Secondary outcome [1] 331332 0
Programme sustainability will be explored with key informants who work in health policy. These interviews will be undertaken with experts who have extensive experience in the area of research, policy, management level, and/or cancer service provision across the primary, secondary and palliative care cancer interface. With informed consent, semi structured interviews will be undertaken with participants by a trained researcher who is part of the study team. The interviews will focus on positive features of cancer support programmes, the types of organisational processes (including community, workforce and policy environments) that are consistent with a sustainable Maori cancer support whanau programme. We plan to undertake approximately 10-12 key informant interviews. We will complement the information obtained from the key informant interviews with secondary data documents related to cancer support, including the six cancer treatment centres throughout Aotearoa/NZ and specific district health boards who provide information on cancer support available to patients.
Timepoint [1] 331332 0
Key informants will be interviewed before the programme commences.

Eligibility
Key inclusion criteria
Key inclusion criteria are key informants working in community cancer care and health policy, and programme participants are whanau who are experiencing the cancer journey.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Whanau who have no experience of cancer and have not attended the programme will not be eligible to participate.

Study design
Purpose of the study
Educational / counselling / training
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)
not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
the support programme will be implemented across three sites. Each site will implement the programme in their own way. whanau who participate in the programme will be invited to be interviewed after programme completion.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Interviews will be recorded and transcribed. Thematic analyses will be undertaken on the interview transcripts using the following steps: (i) familiarizing with the data by repeated reading of the transcripts; (ii) coding the transcripts by hand; (iii) searching for themes; (iv) reviewing and refining the themes using qualitative analysis software NVIVO (QSR International Pty Ltd, Doncaster, Australia); and (iv) comparing the established themes with the entire data set. A paper trail will document methodological and analytic decisions to ensure procedural rigour.
We will then use a multiple case study analysis (Stake, 2006) which emphasizes better understanding of each of the cases included in the project as well as providing a basis for cross case comparisons. The initial framework developed for the whanau support programme will serve as the basis for this stage of the analysis that considers all of the data together (Aims 1-3). Thus, a ‘before’ and ‘after’ programme implementation approach will be utilised to evaluate the key themes (for each case individually and also for cross case comparison) of: (a) whanau supportive care needs and whether the programme design successfully did or did not meet those needs including in its capacity to be dynamic based on the changing needs of the group; (b) MHP and/or policy environment; (c) whanau and community engagement (including cancer providers, clinicians, funders, managers, policy makers, community leaders);and (d) gaps and challenges in sustainability including the evidence and practice around sustainability and ways forward in terms of improving or promoting sustainable programmes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2017
Actual
Date of last participant enrolment
Anticipated
29/03/2019
Actual
Date of last data collection
Anticipated
29/03/2019
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 8636 0
New Zealand
State/province [1] 8636 0
Wellington, Kapiti Coast, Wairarapa

Funding & Sponsors
Funding source category [1] 295539 0
Government body
Name [1] 295539 0
Health Research Council of New Zealand
Country [1] 295539 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Centre for Public Health Research
Massey University Wellington
Block 3, Level D, Entrance B, Wallace Street,Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 294357 0
Other Collaborative groups
Name [1] 294357 0
Mana Wahine
Address [1] 294357 0
Mana Wahine
Kokiri Marae
7-9 Barnes Street
Seaview
Lower Hutt
Country [1] 294357 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296860 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 296860 0
Ethics committee country [1] 296860 0
New Zealand
Date submitted for ethics approval [1] 296860 0
11/10/2016
Approval date [1] 296860 0
07/11/2016
Ethics approval number [1] 296860 0
16/CEN/154

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

Contacts
Principal investigator
Name 72254 0
Dr Lis Ellison-Loschmann
Address 72254 0
Centre for Public Health Research
Massey University Wellington
Block 3, Level D, Entrance B, Wallace Street,Wellington 6021
Country 72254 0
New Zealand
Phone 72254 0
+64 4 9793097
Fax 72254 0
Email 72254 0
[email protected]
Contact person for public queries
Name 72255 0
Tira Albert
Address 72255 0
Mana Wahine
Kokiri Marae
7-9 Barnes Street
Seaview
Lower Hutt 5010
Country 72255 0
New Zealand
Phone 72255 0
+64 4-939 7111
Fax 72255 0
Email 72255 0
[email protected]
Contact person for scientific queries
Name 72256 0
Lis Ellison-Loschmann
Address 72256 0
Centre for Public Health Research
Massey University Wellington
Block 3, Level D, Entrance B, Wallace Street,Wellington 6021
Country 72256 0
New Zealand
Phone 72256 0
+64 4 9793097
Fax 72256 0
Email 72256 0
[email protected]

No information has been provided regarding IPD availability


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.