Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000829617
Ethics application status
Approved
Date submitted
10/07/2023
Date registered
2/08/2023
Date last updated
22/02/2024
Date data sharing statement initially provided
2/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing a Nurse-Enabled, Shared-Care Model to Address Unmet Needs of People with Neuroendocrine Tumours
Scientific title
Implementing a Nurse-Enabled, Shared-Care Model to Address Unmet Needs of People with Neuroendocrine Tumours – a randomised-controlled type II hybrid effectiveness-implementation trial (the AUS-NET trial)
Secondary ID [1] 308039 0
None
Universal Trial Number (UTN)
Trial acronym
AUS-NET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Neoplasms 329375 0
Condition category
Condition code
Cancer 326318 326318 0 0
Neuroendocrine tumour (NET)
Public Health 326319 326319 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention (entitled: AUS-NET-Survivorship) has been developed through a co-design process with end-users (people with neuroendocrine neoplasms (NEN), general practitioners, practice nurses, cancer specialists, and cancer nurses). AUS-NET-Survivorship strategically uses specialist neuroendocrine nurses (SNN) - an existing workforce embedded in the health system - to implement a shared, follow-up care model between acute cancer care centres and general practices for people diagnosed with NEN. SNN's are trained and supported to (1) engage all stakeholders (patients, families, general practitioners, specialists, and allied health) to take an active role in cancer survivorship care in a shared, follow-up care model; (2) ensure timely information exchange and negotiation of shared-responsibilities through multidisciplinary case conferencing (Medical Benefits Schedule MBS - Item 750); and (3) ensure general practitioners and practice nurses have access to a survivorship care plan and a range of evidenced-based tools and resources. The intervention explicitly provides shared-care (interchanging specialist and general practice appointments during follow-up cancer care for people with NEN) and enhanced care (overlaying general practice appointments with specialist appointments during follow-up care), depending on the clinical needs of the people with NEN who are randomised to the intervention.

The intervention will comprise of the following key elements:

1. The local AUS-NET nurse led clinic is a 1 x 30-60 minute face-to-face or telehealth SNN consult with the participant scheduled within 10 weeks of diagnosis/enrolment (however given the pragmatic study design, adjustments to this timeline may be made and documented on a site-by-site basis) to: 1) provide treatment summary; 2) provide survivorship patient education including a written survivorship booklet titled "Neuroendocrine tumours: A guide for patients and carers” published by Neuroendocrine Cancer Australia; 3) co-develop a draft Survivorship Care Plan (SCP) including SMART goals (using motivational interviewing and self-efficacy techniques); and 4) provide a draft shared-care follow-up appointment schedule. A draft SCP (including the treatment summary) will be provided to the participant via email or post and their nominated GP via GP clinic preferred communication system. Adherence to the nurse-led clinic and its components will be monitored using a nurse-led clinic checklist. The approximate duration of the care plan would be updated by the intervention participant together with their health care provided e.g., GP, specialist nurse, dependent on their individual needs up to 5 years. A finalised copy will be valid till the intervention participant and their health care provider decides to update it.

2. There will be 1 x 20–30-minute video/telephone case-conference between the GP, the Practice Nurse (if available) and 3) the local SNN and/or the AUS-NET National Nurse Coordinator (NNC) +/- another allied health professional depending on patients’ needs. The case-conference will be scheduled within 4 weeks of the local SNN-led clinic via telephone or video-conferencing as per the general practice’s preference. The purpose of the case-conference is to finalise the SCP and negotiate the GP’s role in facilitating SCP SMART goals as well as seek agreement on the shared-care follow-up appointment schedule. During this, the SCP will be shared with relevant parties, i.e., GP and/or practice nurse. Participants receiving the intervention will also receive a copy for them to pass on to anyone that they deem necessary e.g., allied health professionals they are seeing. Where a multidisciplinary case conferencing cannot be organised, the local SNN/AUS-NET NNC will conduct a telephone handover with the GP +/- Practice Nurse to discuss the patient’s survivorship care plans and relevant care needs. Adherence to the GP case conference and its components will be monitored using a GP case conference checklist.

3. GP and Specialist Follow-Up Schedules: AUS-NET Survivorship provides GPs and specialists with guidance on the standardised, minimal follow-up schedule for up to 12 months. Specialist visits can be conducted by the patient’s primary cancer physician as determined by the site. Each GP and Specialist follow-up visit will be guided by session plans which includes guidance on: taking personal histories; enquiring about persistent symptoms requiring investigations; physical examination schedule; avoiding clinical procedures (e.g., scans and blood tests) that may not be indicated; toxicities of cancer treatment; promotion of healthy lifestyle; and appropriate referrals to nursing and allied health services.

The overall duration of the study is 5 years.
Intervention code [1] 325667 0
Behaviour
Comparator / control treatment
Participants randomised to the usual care condition will receive standard follow-up care (specialist-led care) plus a written survivorship booklet on “Neuroendocrine tumours: A guide for patients and carers” published by Neuroendocrine Cancer Australia. Current follow-up arrangements in the specialist-led model, including correspondence with the general practice team, are determined by their treating NEN specialist/s. Current usual care for each study site will be mapped prior to any participant enrolment.
Control group
Active

Outcomes
Primary outcome [1] 334178 0
Health-related Quality of Life - measured via the EORTC QLQ-C30
Timepoint [1] 334178 0
Baseline, 6 months post-baseline, 12 months post-baseline.
Secondary outcome [1] 419664 0
Health-related quality of life - measured via the GINET-21
Timepoint [1] 419664 0
Baseline, 6 months post-baseline, 12 months post-baseline.
Secondary outcome [2] 419665 0
Care coordination - measured via the Cancer Care Coordination Questionnaire (CCCQ)
Timepoint [2] 419665 0
Baseline, 6 months post-baseline, 12 months post-baseline.
Secondary outcome [3] 419666 0
Insomnia - measured via the Insomnia Severity Index
Timepoint [3] 419666 0
Baseline, 12 months post-baseline.
Secondary outcome [4] 419667 0
Cancer-related Fatigue - measured via the Brief Fatigue Inventory
Timepoint [4] 419667 0
Baseline, 12 months post-baseline.
Secondary outcome [5] 419669 0
Simplified Nutrition Appetite Questionnaire (SNAQ)
Timepoint [5] 419669 0
Baseline, 6 months post-baseline and 12 months post-baseline
Secondary outcome [6] 419670 0
Active Australia Survey (AAS)
Timepoint [6] 419670 0
Baseline, 6 months post-baseline and 12 months post-baseline,
Secondary outcome [7] 419671 0
Financial Toxicity - measured via the Comprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) tool
Timepoint [7] 419671 0
Baseline, 12 months post-baseline,
Secondary outcome [8] 419672 0
Adherence to NEN monitoring and cancer treatment - measured via hospital records
Timepoint [8] 419672 0
Annually until 5-years post-baseline
Secondary outcome [9] 419673 0
Overall survival - measured via hospital records
Timepoint [9] 419673 0
Annually until 5-years post-baseline
Secondary outcome [10] 419674 0
Unplanned hospital admissions - measured via self-report and verified with hospital records
Timepoint [10] 419674 0
Annually until 5-years post-baseline
Secondary outcome [11] 419675 0
Satisfaction of care - measured via a single-item question with a 0-10 numerical analogue scale (with 10 being the most satisfied) supplemented with short, structured qualitative questions.
Timepoint [11] 419675 0
12 months post-baseline
Secondary outcome [12] 419676 0
% Model of care uptake among eligible patients - measured via cancer centre record audit and record in study database
Timepoint [12] 419676 0
End of study
Secondary outcome [13] 419680 0
% Eligible patients offered AUS-NET Survivorship - measured via cancer centre records audit and record in study database
Timepoint [13] 419680 0
End of study
Secondary outcome [14] 419681 0
% GPs agreeing to participate - measured via research nurse records in database
Timepoint [14] 419681 0
End of study
Secondary outcome [15] 419682 0
Completion (Y/N) and duration (min) of Case Conferencing with GP - obtained via specialist neuroendocrine nurse records, audio-/video-recording of the GP case conference, completion of the GP Case-conference checklist and research nurse records in database (verified with hospital records).
Timepoint [15] 419682 0
End of study
Secondary outcome [16] 419683 0
Completion (Y/N) and duration (min) of SNN-led clinic - obtained via specialist neuroendocrine nurse (SNN) records, audio-/video-recording of the SNN-led clinic, completion of SNN-led clinic checklist and RN records in database (verified with hospital records)
Timepoint [16] 419683 0
End of study
Secondary outcome [17] 419684 0
Completed survivorship care plan/components (Y/N) - obtained via specialist neuroendocrine nurse (SNN) records, audio-/video-recording of the SNN-led clinic, completion of the SNN-led clinic checklist and RN records in database (verified with AUS-NET Survivorship Care Plans)
Timepoint [17] 419684 0
End of study
Secondary outcome [18] 419685 0
Length of clinical encounters at the cancer centre - obtained via research nurse records in database and hospital record
Timepoint [18] 419685 0
End of study
Secondary outcome [19] 419686 0
Number of access of rapid referral back to acute care - obtained via research nurse records in database and hospital record
Timepoint [19] 419686 0
End of study
Secondary outcome [20] 419687 0
Completed Chronic Disease Management plan (Y/N) - measured via Medicare Benefits Schedule (MBS) records
Timepoint [20] 419687 0
Assessed for the 5 years during enrolment in the study,
Secondary outcome [21] 419688 0
Completed Mental Heath Treatment Plan (Y/N) - measured via Medicare Benefits Schedule (MBS) records
Timepoint [21] 419688 0
Assessed for the 5 years during enrolment in the study,
Secondary outcome [22] 419689 0
Number and timing of GP visits and specialist visits - measured via Medicare Benefits Schedule (MBS) records and patient self-report (verified with hospital records)
Timepoint [22] 419689 0
Assessed for the 5 years during enrolment in the study,
Secondary outcome [23] 419690 0
Health providers (all) satisfaction - measured via semi-structured interviews
Timepoint [23] 419690 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [24] 419691 0
Costing analysis and outcome measurement - measured via the EORTC QLQ-C30 (primary outcome) and the QUL-C10D
Timepoint [24] 419691 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [25] 419692 0
A wide-ranging costing study will be conducted to find the actual cost of provision of care in AUS-NET Survivorship and usual care (Page et al 2013). Costing data will be prospectively collected from multiple sources to enable a robust evaluation from an economic perspective. Individual level costs associated with specialist led usual care and shared care will be estimated from chart reviews and hospital costing data bases. Patient costs associated with travel, loss of productivity and out of pocket expenses will be prospectively measured using a previously applied patient costing survey (modified AusHSI costing tool). The additional cost of AUS-NET Survivorship as a new intervention will also be estimated.

Reference: Page, K., et al., Humans, 'things' and space: costing hospital infection control interventions. J Hosp Infect, 2013. 84(3): p. 200-5.
Timepoint [25] 419692 0
End of Study
Secondary outcome [26] 419693 0
Patient Preference for AUS-NET model of care - measured via a Discrete Choice Experiment (DCE).
Timepoint [26] 419693 0
End of study
Secondary outcome [27] 419694 0
Cost-Benefit Analysis - measured via cost data and Willingness-to-Pay (WTP) values developed in the DCE survey
Timepoint [27] 419694 0
End of study
Secondary outcome [28] 419695 0
Budget Impact Analysis - obtained from collected cost data, service usage, and disease burden information to populate the life-time Markov model. These data will be sourced from a combination of trial results e.g., usage, Medicare Benefit Schedule (MBS) and Pharmaceutical Benefit Schedule (PBS) data, willingness-to-pay from the Discrete Choice Experiments, routine data, and systematic literature reviewing.
Timepoint [28] 419695 0
End of study
Secondary outcome [29] 419696 0
Medicare Benefit Schedule (MBS) - measured via health care consultations, services and procedures in community care and private health services.
Timepoint [29] 419696 0
End of study
Secondary outcome [30] 419697 0
Resources to deliver AUS-NET - this is a composite outcome obtained via resources required to conduct the intervention. A best estimate of the costing data of the following will be collected prospectively from multiple sources to enable a robust evaluation from an economic perspective, and assessed by a health economist - Individual level costs associated with specialist led usual care and shared care will be estimated from chart reviews and hospital costing data bases. Patient costs associated with travel, loss of productivity and out of pocket expenses will be prospectively measured using a previously applied patient costing survey (modified Australia Centre for Health service Innovation (AUS-HSI) costing tool). The additional cost of AUS-NET Survivorship as a new intervention will also be estimated - this includes staff, staff training, materials, communications, space, utilities, healthcare costs, and other societal costs.
Timepoint [30] 419697 0
End of study
Secondary outcome [31] 424459 0
Malnutrition Screening Tool (MST)
Timepoint [31] 424459 0
Baseline, 6 months post-baseline and 12 months post-baseline
Secondary outcome [32] 424460 0
CSIRO Healthy Eating score
Timepoint [32] 424460 0
Baseline, 6 months post-baseline and 12 months post-baseline
Secondary outcome [33] 424461 0
International Physical Activity Questionnaire (IPAQ) - single item
Timepoint [33] 424461 0
Baseline, 6 months post-baseline and 12 months post-baseline
Secondary outcome [34] 424739 0
Pharmaceutical Benefit Schedule (PBS) Service Utilisation - measured via prescription medications.
Timepoint [34] 424739 0
End of study

Eligibility
Key inclusion criteria
- Patients aged 18 years of age or older
- histologically confirmed neuroendocrine neoplasm (NENs) as per the 2017 World Health Organisation Classification:
o Well differentiated neuroendocrine neoplasms: Neuroendocrine tumours (NET) (Grades 1-3)
o Poorly differentiated neuroendocrine neoplasms: Neuroendocrine carcinoma (NEC)
- can identify, or be willing to identify a usual General Practitioner or General Practice
- ambulatory with ECOG performance status of 0-2
- have access to a telephone or telehealth via smartphone, electronic tablet, personal computer, or equivalent, and
- be able to speak and read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients diagnosed with pheochromocytoma or paraganglioma
- Patients with small cell lung NEC or large cell lung NEC
- Patients with severe mental, cognitive, or physical conditions or other circumstance that would limit their ability to participate at the discretion of the treating clinician
- Patients judged to have <6 months of life expectancy at the discretion of the treating clinician
- Patients judged to be unable to provide consent at the discretion of the treating clinician

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers will be used to allocate participants in a 1:1 ratio by a researcher not involved in recruitment, intervention implementation, or data collection. Randomisation is blocked using random permuted blocks of eight and four to ensure that the groups are balanced periodically within stratification groups. Allocation sequence is implemented using sequentially numbered software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Full blinding is not possible in this intervention. However, all data collectors will be blinded to group allocation as baseline data will be collected prior to randomisation. All efforts will be made to ensure the delegated data collector who will be collecting outcome data across all follow-up time points will be blinded. Participants will be instructed not to disclose their allocation (care model) to the delegated data collector, who will not be involved in the participants cancer care.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Effectiveness outcomes:
Mean differences in primary outcomes between groups at 12 months will be assessed using linear mixed models to account for repeated measures. The analysis will be adjusted by the stratification variables. Maximum likelihood will be used to account for missing data with chi-square and t-test used to explore missing patterns. Hypothesis tests for the primary outcomes will be two-tailed with results being considered as statistically significant when P < 0.0288675.

Implementation Outcomes:
Qualitative data will be analysed using thematic analysis techniques. Two members of the research team will code the data independently and using an inductive-deductive approach, informed by the revised RE-AIM framework [1],using qualitative data analysis software, NVivo. A thematic framework of coding, data sorting and summation/synthesis of data will be referenced to assess the content of all interviews. The transcripts will be repeatedly read to gain a sense of generated codes initially while creating the thematic framework to help the researchers identify recurrent patterns. Discussions with the research team will be carried out until an agreement is reached for any coding discrepancies.

Secondary Outcomes:
Linear mixed models will be used to estimate the intervention effect for continuous secondary outcomes, using a random intercept model with time as a fixed effect. Models will explore the effects of group, time, and their interaction with adjustments as described in the primary analysis. Results will be presented as means differences. Post hoc comparison for interaction terms will be conducted using Tukey adjustments. Hypothesis tests for secondary outcomes will be two-tailed with results considered statistically significant when P < 0.05. Decisions about the importance of results will consider both statistical significance and clinical importance. Categorical outcomes will be analysed using generalised mixed models with appropriate link functions chosen based on their distribution. Survival will be described using median survival and Kaplan Meier and modelled using Cox regression, with hazard ratios and 95% confidence intervals reported. Assumptions of all models will be assessed by examining models’ residuals with descriptive statistics and plots, with appropriate solutions provided as required (e.g., Bootstrapping). All analysis will be conducted using an intention-to-treat framework. We will also monitor the characteristics (i.e., cancer stage, age, comorbidities, and socio-economic indexes for areas) of patients recruited to intervention and control arms, and adjust for differences at the analysis stage. Interpretation of effect size based on trivial, small, medium and large based on guidance from Cocks et al (2011) [2].

Reference:
1. Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM planning and evaluation framework: adapting to new science and practice with a 20-year review. Frontiers in public health. 2019 Mar 29;7:64.
2. Cocks K, King MT, Velikova G, de Castro Jr G, St-James MM, Fayers PM, Brown JM. Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. European journal of cancer. 2012 Jul 1;48(11):1713-21

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 25070 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 25071 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 25072 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 25073 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 25074 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 40733 0
5011 - Woodville
Recruitment postcode(s) [2] 40734 0
6150 - Murdoch
Recruitment postcode(s) [3] 40735 0
4029 - Herston
Recruitment postcode(s) [4] 40736 0
3000 - Melbourne
Recruitment postcode(s) [5] 40737 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 312298 0
Government body
Name [1] 312298 0
Australian Government Department of Health and Aged Care
Country [1] 312298 0
Australia
Primary sponsor type
University
Name
Caring Futures Institute, College of Nursing and Health Sciences, Flinders University
Address
College of Nursing and Health Sciences
Flinders University,
Sturt Road, Bedford Park, South Australia, 5042
Country
Australia
Secondary sponsor category [1] 316314 0
None
Name [1] 316314 0
Address [1] 316314 0
Country [1] 316314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311667 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 311667 0
Ethics committee country [1] 311667 0
Australia
Date submitted for ethics approval [1] 311667 0
11/11/2022
Approval date [1] 311667 0
29/05/2023
Ethics approval number [1] 311667 0

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

Contacts
Principal investigator
Name 121922 0
Prof Raymond Chan
Address 121922 0
Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
Country 121922 0
Australia
Phone 121922 0
+61 08 8201 3099
Fax 121922 0
Email 121922 0
[email protected]
Contact person for public queries
Name 121923 0
Raymond Chan
Address 121923 0
Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
Country 121923 0
Australia
Phone 121923 0
+61 08 8201 3099
Fax 121923 0
Email 121923 0
[email protected]
Contact person for scientific queries
Name 121924 0
Raymond Chan
Address 121924 0
Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
Country 121924 0
Australia
Phone 121924 0
+61 08 8201 3099
Fax 121924 0
Email 121924 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


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.