Emma McShane, Kate Furness, Lauren Hanna, Kate Connell, Terrence Haines, Catherine E Huggins, John Zalcberg, Sharon Carey, Charles H C Pilgrim, Joanne Lundy, Andrew Metz, David Kissane, Michael Franco, John Coutsouvelis, Diederick W De Boo, J Simon Bell, Mahesh Iddawela, Theresa Dodson, Ignatius Pereira, Nina Imad, Jill Kirkpatrick, Cherie Dear, Daniel Croagh
{"title":"评估由营养师主导的远程医疗强化干预对胰腺癌患者生活质量的影响：随机对照试验方案。","authors":"Emma McShane, Kate Furness, Lauren Hanna, Kate Connell, Terrence Haines, Catherine E Huggins, John Zalcberg, Sharon Carey, Charles H C Pilgrim, Joanne Lundy, Andrew Metz, David Kissane, Michael Franco, John Coutsouvelis, Diederick W De Boo, J Simon Bell, Mahesh Iddawela, Theresa Dodson, Ignatius Pereira, Nina Imad, Jill Kirkpatrick, Cherie Dear, Daniel Croagh","doi":"10.1186/s12937-025-01113-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>31st January 2024, Australian and New Zealand Clinical Trial Registry (Trial ID/No. ACTRN12624000084583).</p>","PeriodicalId":19203,"journal":{"name":"Nutrition Journal","volume":"24 1","pages":"54"},"PeriodicalIF":4.4000,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Emma McShane, Kate Furness, Lauren Hanna, Kate Connell, Terrence Haines, Catherine E Huggins, John Zalcberg, Sharon Carey, Charles H C Pilgrim, Joanne Lundy, Andrew Metz, David Kissane, Michael Franco, John Coutsouvelis, Diederick W De Boo, J Simon Bell, Mahesh Iddawela, Theresa Dodson, Ignatius Pereira, Nina Imad, Jill Kirkpatrick, Cherie Dear, Daniel Croagh\",\"doi\":\"10.1186/s12937-025-01113-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>31st January 2024, Australian and New Zealand Clinical Trial Registry (Trial ID/No. ACTRN12624000084583).</p>\",\"PeriodicalId\":19203,\"journal\":{\"name\":\"Nutrition Journal\",\"volume\":\"24 1\",\"pages\":\"54\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2025-04-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nutrition Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12937-025-01113-9\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"NUTRITION & DIETETICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nutrition Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12937-025-01113-9","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NUTRITION & DIETETICS","Score":null,"Total":0}
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).
期刊介绍：
Nutrition Journal publishes surveillance, epidemiologic, and intervention research that sheds light on i) influences (e.g., familial, environmental) on eating patterns; ii) associations between eating patterns and health, and iii) strategies to improve eating patterns among populations. The journal also welcomes manuscripts reporting on the psychometric properties (e.g., validity, reliability) and feasibility of methods (e.g., for assessing dietary intake) for human nutrition research. In addition, study protocols for controlled trials and cohort studies, with an emphasis on methods for assessing dietary exposures and outcomes as well as intervention components, will be considered.
Manuscripts that consider eating patterns holistically, as opposed to solely reductionist approaches that focus on specific dietary components in isolation, are encouraged. Also encouraged are papers that take a holistic or systems perspective in attempting to understand possible compensatory and differential effects of nutrition interventions. The journal does not consider animal studies.
In addition to the influence of eating patterns for human health, we also invite research providing insights into the environmental sustainability of dietary practices. Again, a holistic perspective is encouraged, for example, through the consideration of how eating patterns might maximize both human and planetary health.
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