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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
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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
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Secondary ID [1]
311931
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MRFF 2022 Pancreatic Cancer Research Application ID 2024360
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Universal Trial Number (UTN)
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Trial acronym
PANConnect (Patient and Nurse Connect) Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer
333521
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Condition category
Condition code
Cancer
330203
330203
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0
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Pancreatic
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Public Health
331212
331212
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0
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Other public health
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328392
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain and symptom burden (composite primary outcome) assessed using the Functional Assessment of Cancer Therapy – Hepatobiliary (Version 4) Trial Outcome Index (FACT-Hep TOI)
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Assessment method [1]
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Functional Assessment of Cancer Therapy – Hepatobiliary (Version 4) Trial Outcome Index (summation of the physical and functional wellbeing and hepatobiliary cancer subscales) - Cella et al., Qual Life Res 2013, 22(5):1105-1112.
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Timepoint [1]
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Recruitment to trial (baseline); 12-weeks post-recruitment (trial end-point)
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Secondary outcome [1]
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Financial wellbeing
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Assessment method [1]
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Functional Assessment of Chronic Illness Therapy-COmprehensive Score for financial Toxicity (FACIT-COST) as per de Souza et al., Cancer 2017, 123(3):476-484.
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Timepoint [1]
433876
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Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
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Secondary outcome [2]
433877
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Emotional health - depression
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Assessment method [2]
433877
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Patient Reported Outcomes Measurement Information System (PROMIS) Depression 8b short-form scale as per Garcia et al., J Clin Oncol 2007, 25(32):5106-5112.
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Timepoint [2]
433877
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Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
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Secondary outcome [3]
433878
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Emotional health - anxiety
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Assessment method [3]
433878
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Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 7a short-form scale as per Garcia et al., J Clin Oncol 2007, 25(32):5106-5112.
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Timepoint [3]
433878
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Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
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Secondary outcome [4]
433879
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Problems affecting quality of life and (unmet) needs for care
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Assessment method [4]
433879
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Problems and Needs in Palliative Care questionnaire-short version (Osse et al., Palliat Med 2007, 21(5):391-399).
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Timepoint [4]
433879
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Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
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Secondary outcome [5]
433880
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Supportive care needs
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Assessment method [5]
433880
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Supportive Care Needs Survey – Partners and Caregivers (Girgis et al., Psychooncology 2011, 20(4):387-393).
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Timepoint [5]
433880
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Recruitment (baseline); 12-weeks post-recruitment (trial end-point)
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Secondary outcome [6]
433881
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Health service use - this will be assessed as a composite outcome
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Assessment method [6]
433881
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Data will include use of Medicare-rebated (e.g., prescriptions, GP consultations) and non-Medicare-rebated health service use (e.g. hospital admissions, outpatient visits, ambulance use etc.). Medicare-rebated health service use will be obtained from Services Australia. Non-Medicare-rebated health service use will be collected via the 12-week data collection tool completed by patients, hospital medical records and the Centre for Victorian Data Linkage. Resources used in intervention delivery (e.g., hours of PANConnect nurse time) will be captured via activity logs. PANConnect nurse time will be valued according to state nursing salary awards. Service use will be costed using existing unit costs sources (e.g. Medicare fee schedule).
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Timepoint [6]
433881
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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).
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Secondary outcome [7]
433882
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Implementability (i.e., acceptability, feasibility, and fidelity) of the PANConnect intervention
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Assessment method [7]
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A brief survey encompassing the Theoretical Framework of Acceptability (TFA - Sekhon et al., BMC Health Serv Res 2017, 17(1):88); semi-structured interview guided by the Consolidated Framework for Implementation Research (CFIR - Damschroder et al., Implement Sci 2022, 17(1):75).
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Timepoint [7]
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4-weeks following recruitment to the trial (purposively selected participants assigned to the intervention arm)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
6/01/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
146
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26778
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [2]
26779
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Bendigo Health Care Group - Bendigo Hospital - Bendigo
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Recruitment hospital [3]
26780
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Border Medical Oncology - Albury
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Recruitment hospital [4]
26782
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Jessie McPherson Private Hospital - Clayton
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Recruitment hospital [5]
26783
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [6]
26784
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Peninsula Oncology Centre - Frankston
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Recruitment hospital [7]
26785
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [8]
26786
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Warringal Private Hospital - Heidelberg
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Recruitment postcode(s) [1]
42829
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3084 - Heidelberg
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Recruitment postcode(s) [2]
42830
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3550 - Bendigo
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Recruitment postcode(s) [3]
42831
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2640 - Albury
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Recruitment postcode(s) [4]
42833
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3168 - Clayton
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Recruitment postcode(s) [5]
42834
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3199 - Frankston
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Recruitment postcode(s) [6]
42835
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3065 - Fitzroy
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Funding & Sponsors
Funding source category [1]
316276
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Government body
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Name [1]
316276
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Australian Government Department of Health and Aged Care Medical Research Future Fund
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Address [1]
316276
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Country [1]
316276
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Australia
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Primary sponsor type
Hospital
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Name
Peter MacCallum Cancer Centre
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Address
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Country
Australia
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Secondary sponsor category [1]
319182
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None
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Name [1]
319182
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Address [1]
319182
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Country [1]
319182
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
315095
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Peter MacCallum Cancer Centre Human Research Ethics Committee
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Ethics committee address [1]
315095
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https://www.petermac.org/research/doing-research-us/ethics-governance
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Ethics committee country [1]
315095
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Australia
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Date submitted for ethics approval [1]
315095
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01/10/2024
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Approval date [1]
315095
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Ethics approval number [1]
315095
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Summary
Brief summary
This study aims to evaluate the impact of the PANConnect intervention in addition to usual care on pain and symptom burden among patients with pancreatic cancer compared to usual care alone. Emotional distress, unmet needs, financial wellbeing, and the relative impact on health service use will also be assessed. Who is it for? You may be eligible to join this study if you are a patient aged 18 or older; have a confirmed diagnosis of pancreatic adenocarcinoma at any stage; have a life expectancy of at least three months, as indicated by your treating consultant; and are receiving your initial care at a trial site. You may also be eligible if you are a carer aged 18 or older or a healthcare professional providing or having provided care to participants with pancreatic cancer recruited to the trial. Study details: All patients who meet the eligibility criteria allocated to the PANConnect intervention continue to receive oncology care from their treating team, in addition to the PANConnect intervention. 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. Before and after completion of the intervention, participants will be assessed for pain and symptom burden, unmet needs, financial wellbeing, emotional health and health service usage. It is also hoped that this research project will also inform the implementability of PANConnect and develop an effective scaling-up strategy to support future implementation efforts.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Meinir Krishnasamy
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Address
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Department of Nursing, Melbourne School of Health Sciences, Alan Gilbert Building, University of Melbourne, 161 Barry St, Carlton VIC 3010
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Country
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Australia
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Phone
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+61 410515452
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Meabh Cullinane
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Address
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Department of Health Services Research, Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3052
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Country
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Australia
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Phone
133663
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+61 3 85595000
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Fax
133663
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Email
133663
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[email protected]
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Contact person for scientific queries
Name
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Meinir Krishnasamy
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Address
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Department of Nursing, Melbourne School of Health Sciences, Alan Gilbert Building, University of Melbourne, 161 Barry St, Carlton VIC 3010
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Country
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Australia
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Phone
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+61 410515452
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Fax
133664
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Email
133664
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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