Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001034527p
Ethics application status
Not yet submitted
Date submitted
23/07/2024
Date registered
27/08/2024
Date last updated
27/08/2024
Date data sharing statement initially provided
27/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Specialist cancer nurse-led telehealth symptom management and care coordination for Australians affected by pancreatic cancer: The PANConnect randomised controlled trial
Scientific title
Assessing the effectiveness of a specialist cancer nurse-led telehealth model of care on pain and symptom management among Australians affected by pancreatic cancer: The PANConnect randomised controlled trial
Secondary ID [1] 311931 0
MRFF 2022 Pancreatic Cancer Research Application ID 2024360
Universal Trial Number (UTN)
Trial acronym
PANConnect (Patient and Nurse Connect) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 333521 0
Condition category
Condition code
Cancer 330203 330203 0 0
Pancreatic
Public Health 331212 331212 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PANConnect intervention is a centralised telehealth model of specialist pancreatic cancer nurse-led care provided to participants assigned to the intervention arm for 12 weeks following recruitment to the study (given the limited life expectancy of patients with pancreatic cancer).

Patients with pancreatic cancer allocated to the PANConnect intervention continue to receive oncology care from their treating team, in addition to the PANConnect intervention (i.e., the intervention is not designed to change care provision pathways that participants receive from their treating service as a component of usual care).

The intervention comprises the following: (1) weekly patient symptom-reporting, (2) symptom assessment and subsequent care coordination by a specialist cancer nurse (the PANConnect nurse) via telehealth, and (3) real-time communication of outcomes from telehealth consultations to the patient’s treating team.

Patient symptom-reporting: The PANConnect intervention is primarily based on the completion of a weekly patient reported outcome measure (PROM) - the PAncreatic CAncer Disease Impact (PACADI) tool. Patients assigned to receive the intervention will complete the PACADI each week for 12 weeks from baseline, measuring the impact of pancreatic cancer in the previous 7 days on eight dimensions: pain/discomfort; fatigue; bowel/digestion; loss of appetite; anxiety; dry mouth; itchiness; and nausea using a scale of 0 to 10, where 0 is ‘no experience’ and 10 is their ‘worst imaginable’ experience. The tool will be hosted on the REDCap platform at the Peter MacCallum Cancer Centre, with a secure link sent by a member of the research team to participants facilitating completion via smart device or computer. Alternatively, for participants with limited internet access, the tool will be completed weekly via telephone with a member of the research team.

Symptom assessment and care coordination: Following completion of weekly PROMs, patients receive a weekly telehealth consultation with the PANConnect study specialist cancer nurse (please note: if a patient has not completed the PACADI PROM prior to their scheduled consultation, the PANConnect nurse will complete this with the patient at the start of the consultation).

The PANConnect nurse reviews participants’ PACADI responses (including checks for missing responses), grades the severity of symptoms using the Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE), provides evidence-informed symptom-management support and information to enable self-management (e.g., relevant information from Cancer Council Victoria, Pancare, eviQ), and actions real-time referrals and timely interventions based on symptom severity (e.g., referral to dietetic services, referral to psychological services, symptom review by GP or treating team).

Referrals for services available within each trial site will be communicated to and managed by relevant clinicians at that site. Referrals for services unavailable at, or external to the trial site will be managed by the study specialist cancer nurse, with notification of the referral back to the treating team, thereby ensuring rapid communication of any clinical issues that require follow up.

Any urgent issues, for example symptoms requiring immediate presentation to hospital, such as febrile neutropenia, will be communicated directly by the study nurse to a member of the treating team by telephone. In these instances, the study nurse can also coordinate patient admission (i.e., via ambulance) to the Emergency Department if required.

Communication to clinical team: Following each telehealth consultation, communication about patient-reported symptoms assessed by the PANConnect nurse and referrals recommended will be provided to clinicians at each trial site via a study-specific clinician report provided in real time, with the understanding that responsibility for actioning internal referrals and/or follow-up sits with the relevant clinician at that site. The report will contain relevant patient details (i.e., name, date of birth, treating hospital, hospital UR number, general practitioner details, patient diagnosis, resectability status, significant co-morbidities, and current treatments (if any); an overview of symptoms reported by the patient, and the patient reported symptom severity rating provided; the assessment summary provided by the PANConnect nurse, along with recommendations and agreed plan for each reported symptom; and any recommended referrals to be actioned by the PANConnect nurse and/or the treating service. A report is emailed directly to the patient’s treating team following each telehealth consultation, and copied to the patient’s electronic medical record.

From a previous study assessing the feasibility of this nurse-led model of care, we anticipate the duration of weekly telehealth consultations to be approximately one hour, depending on the severity of symptoms reported by patients and the subsequent complexity of care coordination required by the PANConnect nurse.

In addition to receiving a weekly nurse-initiated follow-up call across the 12-week intervention period, patients and carers randomised to the intervention arm will be able to call the study nurse with any concerns or requests for advice during business hours 8AM – 4PM on weekdays during their participation in the trial.

The PANConnect intervention will be provided to patients for 12 weeks. However, after this time, patients allocated to the intervention arm can continue to contact the study specialist cancer nurse for any queries or concerns that they have, although they will not complete PROMs or receive weekly telehealth consultations.

PANConnect intervention delivery will be captured via activity logs by the PANConnect nurse, and will include patient adherence to the intervention (i.e., number of telehealth consultations attended, number of telehealth consultations missed, and reasons for given); number of clinician reports provided to a participant’s clinical team; number of referrals made (internal and external), and description of referral services used; description of support and information provided to participants; and hours of PANConnect nurse time taken to deliver the intervention.




Intervention code [1] 328392 0
Treatment: Other
Comparator / control treatment
Patients randomised to the usual care arm will have access to all usual oncology care and treatment as agreed by their multidisciplinary team, and after the patient has been made aware of these decisions. These care and treatment decisions can include surgery, chemotherapy, radiotherapy, supportive and palliative care. Usual care varies within and between each study site, depending on factors such as individual hospital guidelines and the range of services available at the hospital. All sites have access to chemotherapy, radiotherapy, and palliative care, with metropolitan services offering surgical interventions if required.
Control group
Active

Outcomes
Primary outcome [1] 337954 0
Pain and symptom burden (composite primary outcome) assessed using the Functional Assessment of Cancer Therapy – Hepatobiliary (Version 4) Trial Outcome Index (FACT-Hep TOI)
Timepoint [1] 337954 0
Recruitment to trial (baseline); 12-weeks post-recruitment (trial end-point)
Secondary outcome [1] 433876 0
Financial wellbeing
Timepoint [1] 433876 0
Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
Secondary outcome [2] 433877 0
Emotional health - depression
Timepoint [2] 433877 0
Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
Secondary outcome [3] 433878 0
Emotional health - anxiety
Timepoint [3] 433878 0
Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
Secondary outcome [4] 433879 0
Problems affecting quality of life and (unmet) needs for care
Timepoint [4] 433879 0
Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
Secondary outcome [5] 433880 0
Supportive care needs
Timepoint [5] 433880 0
Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
Secondary outcome [6] 433881 0
Health service use - this will be assessed as a composite outcome
Timepoint [6] 433881 0
12-week interview using study-specific resource use questions (collected at 12 weeks post-recruitment); routinely collected Medicare data from Services Australia (collected once trial participation for the patient is complete); routinely collected data from the Centre for Victorian Data Linkage (collected once trial participation for the patient is complete); PANConnect nurse activity logs (collected daily); electronic medical record (collected once trial participation for the patient is complete).
Secondary outcome [7] 433882 0
Implementability (i.e., acceptability, feasibility, and fidelity) of the PANConnect intervention
Timepoint [7] 433882 0
4-weeks following recruitment to the trial (purposively selected participants assigned to the intervention arm)

Eligibility
Key inclusion criteria
Patients with pancreatic cancer, family members and support people (carers) of patients with pancreatic cancer, healthcare professionals providing care to patients with pancreatic cancer at trial sites and the study specialist nurses delivering the intervention will be invited to participate.

Patients with pancreatic cancer are eligible to participate if they:
1. Are aged 18 years or older;
2. Have a confirmed diagnosis of pancreatic adenocarcinoma at any stage, independent of resectability;
3. Have a life expectancy of at least three months, as indicated by their treating consultant;
4. Have a documented cancer treatment plan in place, known to the patient; and
5. Are receiving their initial care at a trial site.

Carers are eligible to participate if they:
1. Are aged 18 years or older;
2. Able to speak and read English.

Healthcare professionals are eligible if they are providing or have provided care to patients recruited to the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with pancreatic cancer will not be eligible if they do not have capacity to provide informed consent (e.g., suffering from dementia or delirium). In addition, participants who do not have access to a telephone (mobile or landline) will not be eligible to participate.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After completing baseline measures, people affected by pancreatic cancer recruited to the trial will be randomly allocated to either the usual care arm or intervention arm with stratification by a) site location (metro versus regional/rural) and b) resectable disease (resectable versus non-resectable disease).

A secure, password-protected, computerised randomisation schedule will be designed by an independent service, and accessed online by recruiting staff. The randomisation ratio will be 1:1 PANConnect intervention arm to usual care arm, with permuted blocks of variable length, distributed randomly. Blocks will be pre-assigned to strata.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample is 146 patient participants. We based our sample size calculations on 80% power, a two-sided alpha of 0.05, a standardised difference of 0.5 on the FACT-Hep Trial Outcome Index, a design factor of 0.84 to account for the correlation between baseline and follow-up scores (conservatively estimated at 0.4), and dropout rate of 25%.

We will check the baseline comparability of each arm, and then the intervention arm will be compared to the control group for all study hypotheses using intention-to-treat analysis, which includes all randomised patient participants regardless of the treatment they actually received in this study. A per-protocol analysis will also be conducted, and include all randomised patient participants according to the treatment they actually received in the trial.

Outcome analysis: The impact of the PANConnect intervention on primary and secondary patient- and carer-reported outcomes will be assessed using separate ANCOVAs for each outcome, with study group as the between-subjects factor and relevant baseline score as the covariate. Appropriate transformations of the data will be undertaken where data are not normally distributed.

Recruitment bias: The characteristics of consenters and decliners will be compared using Fisher’s exact test, Pearson’s chi-squared test, Student’s t-test, or the Mann-Whitney U test, as appropriate.

Demographic and clinical characteristics: Descriptive statistics will be used to summarise participants’ demographic and clinical characteristics by study arm. These will include counts and percentages for nominal and crude-scale ordinal (less than 10 levels) valued variables; and means and standard deviations or medians and interquartile ranges, as appropriate, for fine-scale (greater than or equal to 10 levels) ordinal and continuous valued variables.

Operational and other data: Descriptive statistics will also be used to summarise operational data (e.g., withdrawals, losses-to-follow-up), and healthcare resource use data by study arm, and, where relevant, implementation acceptability, feasibility, and fidelity data gathered from patients randomised to the intervention arm.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26778 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 26779 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [3] 26780 0
Border Medical Oncology - Albury
Recruitment hospital [4] 26782 0
Jessie McPherson Private Hospital - Clayton
Recruitment hospital [5] 26783 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [6] 26784 0
Peninsula Oncology Centre - Frankston
Recruitment hospital [7] 26785 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [8] 26786 0
Warringal Private Hospital - Heidelberg
Recruitment postcode(s) [1] 42829 0
3084 - Heidelberg
Recruitment postcode(s) [2] 42830 0
3550 - Bendigo
Recruitment postcode(s) [3] 42831 0
2640 - Albury
Recruitment postcode(s) [4] 42833 0
3168 - Clayton
Recruitment postcode(s) [5] 42834 0
3199 - Frankston
Recruitment postcode(s) [6] 42835 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 316276 0
Government body
Name [1] 316276 0
Australian Government Department of Health and Aged Care Medical Research Future Fund
Country [1] 316276 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 319182 0
None
Name [1] 319182 0
Address [1] 319182 0
Country [1] 319182 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315095 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 315095 0
Ethics committee country [1] 315095 0
Australia
Date submitted for ethics approval [1] 315095 0
01/10/2024
Approval date [1] 315095 0
Ethics approval number [1] 315095 0

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

Contacts
Principal investigator
Name 133662 0
Prof Meinir Krishnasamy
Address 133662 0
Department of Nursing, Melbourne School of Health Sciences, Alan Gilbert Building, University of Melbourne, 161 Barry St, Carlton VIC 3010
Country 133662 0
Australia
Phone 133662 0
+61 410515452
Fax 133662 0
Email 133662 0
meik@unimelb.edu.au
Contact person for public queries
Name 133663 0
Meabh Cullinane
Address 133663 0
Department of Health Services Research, Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3052
Country 133663 0
Australia
Phone 133663 0
+61 3 85595000
Fax 133663 0
Email 133663 0
meabh.cullinane@petermac.org
Contact person for scientific queries
Name 133664 0
Meinir Krishnasamy
Address 133664 0
Department of Nursing, Melbourne School of Health Sciences, Alan Gilbert Building, University of Melbourne, 161 Barry St, Carlton VIC 3010
Country 133664 0
Australia
Phone 133664 0
+61 410515452
Fax 133664 0
Email 133664 0
meik@unimelb.edu.au

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.