Kea Turner , Dae Won Kim , Brian D. Gonzalez , Laurence R. Gore , Erin Gurd , Jeanine Milano , Diane Riccardi , Margaret Byrne , Mohammed Al-Jumayli , Tiago Biachi de Castria , Damian A. Laber , Sarah Hoffe , James Costello , Edmondo Robinson , Juskaran S. Chadha , Sahana Rajasekhara , Emma Hume , Ryan Hagen , Oliver T. Nguyen , Nicole Nardella , Pamela Hodul
{"title":"通过远程观察和营养指导提供支持（STRONG）是一项旨在减少胰腺癌患者营养不良的数字健康干预措施：随机对照试验研究方案","authors":"Kea Turner , Dae Won Kim , Brian D. Gonzalez , Laurence R. Gore , Erin Gurd , Jeanine Milano , Diane Riccardi , Margaret Byrne , Mohammed Al-Jumayli , Tiago Biachi de Castria , Damian A. Laber , Sarah Hoffe , James Costello , Edmondo Robinson , Juskaran S. Chadha , Sahana Rajasekhara , Emma Hume , Ryan Hagen , Oliver T. Nguyen , Nicole Nardella , Pamela Hodul","doi":"10.1016/j.conctc.2024.101271","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Malnutrition is a common and distressing condition among pancreatic cancer patients. Fewer than a quarter of pancreatic cancer patients receive medical nutrition therapy (MNT), important for improving nutritional status, weight maintenance, quality of life and survival. System, provider, and patient level barriers limit access to MNT. We propose to examine the feasibility of a 12-week multi-level, digital health intervention designed to expand MNT access among pancreatic cancer patients.</p></div><div><h3>Methods</h3><p>Individuals with advanced pancreatic cancer starting chemotherapy (N = 80) will be 1:1 randomized to the intervention or usual care. The Support Through Remote Observation and Nutrition Guidance (STRONG) intervention includes system-level (e.g., routine malnutrition and screening), provider-level (e.g., dietitian training and web-based dashboard), and patient-level strategies (e.g., individualized nutrition plan, self-monitoring of dietary intake via Fitbit, ongoing goal monitoring and feedback). Individuals receiving usual care will be referred to dietitians based on their oncologists’ discretion. Study assessments will be completed at baseline, 4-, 8-, 12-, and 16-weeks.</p></div><div><h3>Results</h3><p>Primary outcomes will be feasibility (e.g., recruitment, retention, assessment completion) and acceptability. We will collect additional implementation outcomes, such as intervention adherence, perceived usability, and feedback on intervention quality via an exit interview. We will collect preliminary data on outcomes that may be associated with the intervention including malnutrition, quality of life, treatment outcomes, and survival.</p></div><div><h3>Conclusion</h3><p>This study will advance our knowledge on the feasibility of a digital health intervention to reduce malnutrition among individuals with advanced pancreatic cancer. Trial registration: NCT05675059, registered on December 9, 2022.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000188/pdfft?md5=b7ffcf443fdc62d0a44a11f7b9572a87&pid=1-s2.0-S2451865424000188-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Support Through Remote Observation and Nutrition Guidance (STRONG), a digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial\",\"authors\":\"Kea Turner , Dae Won Kim , Brian D. Gonzalez , Laurence R. Gore , Erin Gurd , Jeanine Milano , Diane Riccardi , Margaret Byrne , Mohammed Al-Jumayli , Tiago Biachi de Castria , Damian A. Laber , Sarah Hoffe , James Costello , Edmondo Robinson , Juskaran S. Chadha , Sahana Rajasekhara , Emma Hume , Ryan Hagen , Oliver T. Nguyen , Nicole Nardella , Pamela Hodul\",\"doi\":\"10.1016/j.conctc.2024.101271\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Malnutrition is a common and distressing condition among pancreatic cancer patients. Fewer than a quarter of pancreatic cancer patients receive medical nutrition therapy (MNT), important for improving nutritional status, weight maintenance, quality of life and survival. System, provider, and patient level barriers limit access to MNT. We propose to examine the feasibility of a 12-week multi-level, digital health intervention designed to expand MNT access among pancreatic cancer patients.</p></div><div><h3>Methods</h3><p>Individuals with advanced pancreatic cancer starting chemotherapy (N = 80) will be 1:1 randomized to the intervention or usual care. The Support Through Remote Observation and Nutrition Guidance (STRONG) intervention includes system-level (e.g., routine malnutrition and screening), provider-level (e.g., dietitian training and web-based dashboard), and patient-level strategies (e.g., individualized nutrition plan, self-monitoring of dietary intake via Fitbit, ongoing goal monitoring and feedback). Individuals receiving usual care will be referred to dietitians based on their oncologists’ discretion. Study assessments will be completed at baseline, 4-, 8-, 12-, and 16-weeks.</p></div><div><h3>Results</h3><p>Primary outcomes will be feasibility (e.g., recruitment, retention, assessment completion) and acceptability. We will collect additional implementation outcomes, such as intervention adherence, perceived usability, and feedback on intervention quality via an exit interview. We will collect preliminary data on outcomes that may be associated with the intervention including malnutrition, quality of life, treatment outcomes, and survival.</p></div><div><h3>Conclusion</h3><p>This study will advance our knowledge on the feasibility of a digital health intervention to reduce malnutrition among individuals with advanced pancreatic cancer. 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Support Through Remote Observation and Nutrition Guidance (STRONG), a digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial
Background
Malnutrition is a common and distressing condition among pancreatic cancer patients. Fewer than a quarter of pancreatic cancer patients receive medical nutrition therapy (MNT), important for improving nutritional status, weight maintenance, quality of life and survival. System, provider, and patient level barriers limit access to MNT. We propose to examine the feasibility of a 12-week multi-level, digital health intervention designed to expand MNT access among pancreatic cancer patients.
Methods
Individuals with advanced pancreatic cancer starting chemotherapy (N = 80) will be 1:1 randomized to the intervention or usual care. The Support Through Remote Observation and Nutrition Guidance (STRONG) intervention includes system-level (e.g., routine malnutrition and screening), provider-level (e.g., dietitian training and web-based dashboard), and patient-level strategies (e.g., individualized nutrition plan, self-monitoring of dietary intake via Fitbit, ongoing goal monitoring and feedback). Individuals receiving usual care will be referred to dietitians based on their oncologists’ discretion. Study assessments will be completed at baseline, 4-, 8-, 12-, and 16-weeks.
Results
Primary outcomes will be feasibility (e.g., recruitment, retention, assessment completion) and acceptability. We will collect additional implementation outcomes, such as intervention adherence, perceived usability, and feedback on intervention quality via an exit interview. We will collect preliminary data on outcomes that may be associated with the intervention including malnutrition, quality of life, treatment outcomes, and survival.
Conclusion
This study will advance our knowledge on the feasibility of a digital health intervention to reduce malnutrition among individuals with advanced pancreatic cancer. Trial registration: NCT05675059, registered on December 9, 2022.
期刊介绍：
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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