Can dietitian-led intensive telehealth support to maximise nutritional intake through dietary strategies, symptom management and the option for 'top-up' small bowel tube feeding improve quality of life in patients with pancreatic cancer?

Intensive nutrition intervention delivered via telehealth, including nutrition counselling, education, symptom management, as well as oral nutrition support +/- supplemental jejunal feeding. WHY To deliver appropriate nutritional support, advice, and symptom management to people with pancreatic cancer undergoing chemotherapy treatment. WHAT Participants randomised to the intervention group will receive dietetic counselling, education, oral nutrition support +/- supplemental jejunal feeding combined with proactive nutrition impact symptom pharmacological management delivered at least weekly via phone or video telehealth for the 6-month trial period. Participants will need regular access to a telephone or computer/smart phone with a camera. Participants who opt to receive supplemental enteral feeding will be given via percutaneous endoscopic or radiologically inserted gastrostomy tube with a jejunal extension (PEG-J or RIG-J) or nasojejunal tube (NJT) via endoscopy or radiology as a day procedure. Feeding regimens will be individualised to meet participants’ specific energy and protein needs, titrated up or down depending on oral energy and protein intake. A participant information pack (designed specifically for the study) will be available to participants, which describes standard, evidence-based practice strategies for managing nutrition impact symptoms (both dietary and medication), and key enteral feeding information (e.g., feed administration, stoma site care, useful contacts etc.). At study commencement, participants will be given baseline prescriptions for antiemetics (metoclopramide 10mg, ondansetron 8mg) and pancreatic enzyme replacement therapy (PERT) (Creon, 25,000IU) to ensure proactive nutrition impact symptom management is feasible. If they require additional medications their treating oncology team can provide this, or the intervention dietitian will liaise (phone or email) with the treating team to provide recommendations. Additional information/resources given to participants during the trial will be sent via email or post. Once the 6-month intervention period has ended, participants with enteral feeding tubes will have these removed. However, if the participant chooses and it is medically appropriate, they may retain the PEG-J/RIG-J/NJT. All participants will have their nutrition care handed over to the dietitian service at their treating health service following the conclusion of the intervention. PROVIDED BY The intervention will be provided by research dietitians who have experience working with the pancreatic cancer population and home enteral nutrition. HOW The dietetic counselling, education, oral nutrition support and pharmacologic nutrition impact symptom management will be delivered via telehealth (phone or video). Feeding tubes will be inserted as a day procedure in hospital. WHERE The intervention delivery occurs wherever the participant chooses to be, provided they have access to receive telehealth including their home, holiday destination, at hospital, etc. WHEN and HOW MUCH * Initial nutrition assessment to be completed by the intervention dietitian after randomisation via telehealth for approximately 60 minutes. * The next contact will be weekly consults (at minimum), with the intervention dietitian via telehealth (phone/video) for the duration of the study intervention period (6-months). Participants may also contact the dietitian via telehealth. *Individualised nutrition support/advice will be provided. Participants’ needs will vary depending on the chemotherapy regimen and nutrition impact symptoms experienced. There will be a standard operating procedure to ensure standardisation. This will ensure a framework for intervention delivery between participants. For those who opt to receive an enteral feeding tube: * Feeding tube insertion will occur as a day procedure. For patients who have undergone any cycles of chemotherapy, enteral tube insertion will only occur if their serum neutrophil level is within the reference range of 1.5-8 x 10^9/l. * As soon as practicable after the feeding tube is inserted, the participant will be visited in their home for training and education on using and caring for the feeding tube. Intervention fidelity will be assessed by: - Number and duration of telehealth contacts between the intervention dietitian and participant during the 6-month intervention period; - Behaviour change techniques used by the intervention dietitian (according to Behaviour Change Technique Taxonomy (v1) (Michie et al, DOI: 10.1007/s12160-013-9486-6). (e.g. goal setting, review of goal setting, self-monitoring of behaviour, problem solving, information on health consequences). - Adherence to PEG-J/RIG-J/NJT insertion procedures, presence and frequency of infections and other complications; - Adherence to intervention dietitian recommendations for dosing and timing of pancreatic enzyme replacement therapy (PERT); - Medical practitioner uptake of intervention dietitian recommendations for medication and prescribing; - Participant adherence to the oral nutrition support/enteral feeding regimen recommended by the intervention dietitian.