Specialist cancer nurse-led telehealth symptom management and care coordination for Australians affected by pancreatic cancer: The PANConnect randomised controlled trial

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.