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

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; Nathan Parker; Tiffany L. Carson; Amir Alishahi Tabriz; Pamela Hodul

Contemporary Clinical Trials Communications (Apr 2024)

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

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,
Nathan Parker,
Tiffany L. Carson,
Amir Alishahi Tabriz,
Pamela Hodul

Affiliations

Kea Turner: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA; Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA; Corresponding author. Department of Health Outcomes and Behavior Moffitt Cancer Center, Moffitt Cancer Center, USA.
Dae Won Kim: Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA
Brian D. Gonzalez: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA
Laurence R. Gore: Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, USA
Erin Gurd: Department of Nutrition Therapy, Moffitt Cancer Center, USA
Jeanine Milano: Department of Nutrition Therapy, Moffitt Cancer Center, USA
Diane Riccardi: Department of Nutrition Therapy, Moffitt Cancer Center, USA
Margaret Byrne: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA
Mohammed Al-Jumayli: Department of Senior Adult Oncology, Moffitt Cancer Center, USA
Tiago Biachi de Castria: Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA
Damian A. Laber: Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA
Sarah Hoffe: Department of Radiation Oncology, Moffitt Cancer Center, USA
James Costello: Department of Diagnostic Imaging and Interventional Radiology, Moffitt Cancer Center, USA
Edmondo Robinson: Department of Oncological Sciences, University of South Florida, USA; Department of Internal and Hospital Medicine, Moffitt Cancer Center, USA; Center for Digital Health, Moffitt Cancer Center, USA
Juskaran S. Chadha: Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA
Sahana Rajasekhara: Department of Supportive Care Medicine, Moffitt Cancer Center, USA
Emma Hume: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA
Ryan Hagen: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA
Oliver T. Nguyen: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA
Nicole Nardella: Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA
Nathan Parker: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA; Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA
Tiffany L. Carson: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA; Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA
Amir Alishahi Tabriz: Department of Health Outcomes and Behavior, Moffitt Cancer Center, USA; Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA
Pamela Hodul: Department of Gastrointestinal Oncology, Moffitt Cancer Center, USA; Department of Oncological Sciences, University of South Florida, USA

Journal volume & issue: Vol. 38
p. 101271

Abstract

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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.

Published in Contemporary Clinical Trials Communications

ISSN: 2451-8654 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Medicine (General)
Website: https://www.journals.elsevier.com/contemporary-clinical-trials-communications/

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