Assessing the impact of an intensive dietitian-led telehealth intervention focusing on nutritional adequacy, symptom control and optional supplemental jejunal feeding, on quality of life in patients with pancreatic cancer: a randomised controlled trial protocol.

[BACKGROUND] Pancreatic cancer is the third leading cause of cancer-related death in Australia, with a persistently poor 5-year survival rate of around 13%. Symptoms arising from the disease and chemotherapy such as epigastric pain, anorexia, bloating and fat-malabsorptive diarrhoea cause poor oral intake and weight loss, and reduce an individual's quality of life and ability to tolerate anti-cancer treatment. The primary aim of this study is to determine if an early, intensive telehealth nutrition intervention can improve quality of life compared to usual care for people undergoing treatment for pancreatic cancer.

[METHODS] This multicentre randomised controlled trial will recruit adults newly diagnosed with borderline resectable, locally advanced or metastatic pancreatic cancer from multiple health services across Victoria (metropolitan and regional). The control group will receive usual nutrition care, which is site-dependent. The intervention group will receive weekly telehealth dietetic consultations for six months, targeting nutritional adequacy through dietary education and counselling, oral nutrition supplement drinks and dietetics-led symptom management advocacy, including appropriate dosing of pancreatic enzymes. Escalation to supplemental jejunal tube feeding may occur if clinically required in the intervention arm. The primary outcome is quality of life (EORTC-QLQ C30 summary score); secondary outcomes include survival, chemotherapy dosing changes, and nutrition status markers including body composition. Outcomes will be measured at baseline, and three- and six-months.

[DISCUSSION] The findings of this study will provide evidence of the impact that intensive nutrition therapy, including counselling, provision of oral nutrition supplement drinks and the option for jejunal feeding, has on quality of life and health outcomes in pancreatic cancer. The consistent dietetic approach with the use of telehealth consultations to reduce malnutrition and aid symptom management challenges the current model of care.

[TRIAL REGISTRATION] 31st January 2024, Australian and New Zealand Clinical Trial Registry (Trial ID/No. ACTRN12624000084583).