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. 2025 Apr 7;24(1):54.
doi: 10.1186/s12937-025-01113-9.

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

Emma McShane  1   2 , Kate Furness  2 , Lauren Hanna  3 , Kate Connell  2 , Terrence Haines  4 , Catherine E Huggins  5   6 , John Zalcberg  7   8 , Sharon Carey  9 , Charles H C Pilgrim  8   10   11 , Joanne Lundy  12   13 , Andrew Metz  14   15   16 , David Kissane  17   18 , Michael Franco  19   20   21 , John Coutsouvelis  22   23 , Diederick W De Boo  24   25 , J Simon Bell  22 , Mahesh Iddawela  8   26 , Theresa Dodson  27 , Ignatius Pereira  25 , Nina Imad  28 , Jill Kirkpatrick  29 , Cherie Dear  29 , Daniel Croagh  27   30
Affiliations

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

Emma McShane et al. Nutr J. .

Abstract

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).

Keywords: Dietitian; Malnutrition; Nutrition; Nutrition impact symptoms; Pancreatic cancer; Pancreatic exocrine insufficiency; Randomised controlled trial; Tube feeding.

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Conflict of interest statement

Declarations. Ethics approval: This study has undergone a full ethical review by the Human Research Ethics Committee at Monash Health and was approved on 30th of January 2024. Site-specific authorisation will be obtained from all sites prior to recruitment at each site. This trial was registered prospectively on the Australian New Zealand Clinical Trial Registry on 31st January 2024 (Trial ID: CTRN12624000084583). Human ethics and consent to participate declaration: N/A Consent for publication: N/A. Competing interests: The authors declare no competing interests. Trial sponsor: Monash University Australia.

Figures

Fig. 1
Fig. 1
Precipitants and consequences of malnutrition
Fig. 2
Fig. 2
Study flow chart
See this image and copyright information in PMC

References

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