Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000802707
Ethics application status
Approved
Date submitted
25/05/2022
Date registered
8/06/2022
Date last updated
28/10/2024
Date data sharing statement initially provided
8/06/2022
Date results provided
28/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing unmet social needs using a health navigator for cancer patients at a major metropolitan hospital: a mixed-methods feasibility and acceptability study
Scientific title
Addressing unmet social needs using a health navigator for cancer patients at a major metropolitan hospital: a mixed-methods feasibility and acceptability study
Secondary ID [1] 307217 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 326450 0
Social disadvantage 326451 0
Condition category
Condition code
Public Health 323728 323728 0 0
Health service research
Cancer 323754 323754 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Health Navigator (HN) intervention will take place in the Northern Cancer Centre at the Lyell McEwin Hospital (LMH). Participants will be screened for unmet health-related social needs (food and housing instability, financial insecurity, social isolation etc) in the Cancer Centre using a validated screening tool for unmet social needs developed in collaboration with LMH staff and patients: the Unmet Needs Screening Tool (UNST). Participants with unmet needs will be referred, with their consent, to a HN to help connect them community resources that may be able to help with their unmet needs. The HN is a community worker with experience in the community services sector and an understanding of hospital workflow and clinical trials, with experience working with highly vulnerable and disadvantaged populations. To perform the HN role, the HN will undergo 4 days of training in understanding cancer and cancer treatment, case management principles, familiarisation with community organisations and culturally safe methods of providing case management.

Participants have the choice to meet with the HN in the Cancer Centre or from their home via a Zoom meeting, telephone call or other electronic communication platforms at a time that is convenient for them. During this initial meeting, the HN will develop a collaborative plan with the participant to prioritise their unmet needs, which should take approximately 60 minutes, and advocate for them in setting up appointments and referrals with appropriate community services. For example, if a participant is struggling with finances and budgeting, the HN will provide a warm handover to Anglicare financial planning services, offering them assistance by booking the appointment for them, filling out paperwork with them, ensuring they have all the necessary information, or attending the appointment with them if they require further support. The HN will then organise a follow-up time with the participant, either in-person or remotely, to discuss whether their referral was useful, if they need further help/clarification or want to try another service. This follow-up is scheduled to occur once per month at the participant's convenience, but they are also able to contact the HN on an ad hoc basis (during their work hours) whenever they require. This follow-up will occur once per month for a six month period.

To monitor adherence, the study database contains multiple checkpoints which the HN must report to. The HN will also be supervised by a qualified Social Worker to ensure they are following case management guidelines.
Intervention code [1] 323657 0
Treatment: Other
Comparator / control treatment
All participants will complete baseline questionnaires assessing their quality of life (QoL), coping with cancer ability (CBI-C) and a patient reported outcomes measure (PROM). Participants with no unmet needs will not be referred to the HN for service navigation and follow-up. After the six month navigation period, all participants will be contacted again to repeat the initial three measures. The participant group not receiving navigation is the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 331477 0
Feasibility of implementing a Health Navigator intervention in a Cancer Centre to screen and provide service navigation for unmet needs.
Feasibility will be defined as:
• Recruitment rate for the HN-intervention among eligible participants
• Average number of HN contacts & HN-led engagements for participants & community partners
• Study completion & retention rates
Timepoint [1] 331477 0
Upon completion of the study.
Primary outcome [2] 331478 0
Acceptability of implementing a Health Navigator intervention in a Cancer Centre to screen and provide service navigation for unmet needs.
Acceptability will be defined as:
• Patient satisfaction, perceived relevance, experiences with HN-intervention and key elements to improve HN engagement (collected through focus groups)
• Main reasons for non-participation among eligible participants (collected through focus groups)
• Main reasons for study withdrawal (reasons for withdrawal are collected by the HN as they follow-up with participants), and degree of missingness among recruited patients (follow-up appointments will be recorded during the study, so number of follow-ups attended and not attended will be available at the end of the study period)
• Barriers and enablers to the acceptance & delivery of the implementation among stakeholders, participants and clinicians (collected through focus groups)
Timepoint [2] 331478 0
Upon completion of the study.
Secondary outcome [1] 410044 0
Quality of life, using the Functional Assessment of Cancer Therapy (FACT-G)
Timepoint [1] 410044 0
Baseline and six months post-intervention commencement, for both study groups.
Secondary outcome [2] 410135 0
Coping with cancer ability, as measured by the Cancer Behaviour Inventory (CBI-C)
Timepoint [2] 410135 0
Baseline and 6 months post-intervention commencement for both study groups.
Secondary outcome [3] 410136 0
Patient Reported Experience Measures, using the Australian Hospital Patient Experience Question Set (AHPQES).
Timepoint [3] 410136 0
Baseline and 6 months post-intervention commencement.

Eligibility
Key inclusion criteria
Receiving cancer treatment at the Northern Cancer Centre with an expected survival rate of more than 6 months,
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Non-English speakers
2) Participants deemed by the Principal Investigator to be unable to take part in the intervention, i.e. in the event of serious physical or mental health complications, e.g. medical deterioration, serious treatment adverse effects or mental health crisis

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2022
Actual
9/08/2022
Date of last participant enrolment
Anticipated
30/10/2023
Actual
6/02/2023
Date of last data collection
Anticipated
30/10/2023
Actual
18/01/2024
Sample size
Target
350
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22433 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 37634 0
5112 - Elizabeth

Funding & Sponsors
Funding source category [1] 311516 0
Charities/Societies/Foundations
Name [1] 311516 0
The Hospital Research Foundation
Country [1] 311516 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Hospital Research Foundation
Address
62 Woodville Road, Woodville South, SA 5011
Country
Australia
Secondary sponsor category [1] 312929 0
None
Name [1] 312929 0
Address [1] 312929 0
Country [1] 312929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310977 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
Ethics committee address [1] 310977 0
Ethics committee country [1] 310977 0
Australia
Date submitted for ethics approval [1] 310977 0
01/06/2022
Approval date [1] 310977 0
08/08/2022
Ethics approval number [1] 310977 0
CALHN HREC ID: 16448

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

Contacts
Principal investigator
Name 119562 0
Dr Christopher Hocking
Address 119562 0
Northern Cancer Centre, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale SA 5112
Country 119562 0
Australia
Phone 119562 0
+61 403657869
Fax 119562 0
Email 119562 0
[email protected]
Contact person for public queries
Name 119563 0
Kate Neadley
Address 119563 0
University of Adelaide Precinct, Level 2 Women's Health Building, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale SA 5112
Country 119563 0
Australia
Phone 119563 0
+61 493426441
Fax 119563 0
Email 119563 0
[email protected]
Contact person for scientific queries
Name 119564 0
Kate Neadley
Address 119564 0
University of Adelaide Precinct, Level 2 Women's Health Building, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale SA 5112
Country 119564 0
Australia
Phone 119564 0
+61 493426441
Fax 119564 0
Email 119564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All non-identifiable data will be shared, i.e. number and nature of unmet health-related social needs, pre/post questionnaire results, number of Health Navigator referrals and community services contacted
When will data be available (start and end dates)?
Start 2023-end 2030
Available to whom?
Researchers with a specific interest in the subject matter, to be decided on a case-by-case basis by the study team.
Available for what types of analyses?
Type of analysis will be determined by the study team on a case-by-case basis.
How or where can data be obtained?
Data can be obtained on request from the PI or Kate Neadley.
Contact [email protected] or [email protected] for all requests.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16194Study protocol  [email protected]
16195Ethical approval  [email protected]
16196Informed consent form  [email protected]
16197Clinical study report  [email protected]
16198Statistical analysis plan  [email protected]



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.