Contemporary clinical trials communications · 2024
Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer.
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Lin Yu Chen, Pimiento Jose M, Milano Jeanine, Riccardi Diane, Mckinnie Nakesha, Hume Emma, Sprow Olivia, Diaz-Carraway Sophia, Budnetz Mara, Hagen Ryan, Al-Jumayli Mohammed, Pereira Allan Lima, Sinnamon Andrew J, Somasundaram Ashwin, Permuth Jennifer B, Tabriz Amir Alishahi, Turner Kea
Аннотация
INTRODUCTION: Individuals with esophageal and gastroesophageal junction (GEJ) cancers are at especially high risk of malnutrition. However, most patients with malnutrition do not receive adequate nutritional support. We conducted a single-arm trial to test the implementation of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital intervention to improve nutritional outcomes for patients with locally advanced esophageal and gastroesophageal junction cancer.
METHODS: Participants received five nutritional counseling sessions with a dietitian, logged daily food intake through the Fitbit app, and completed five study assessments related to patient malnutrition, nutrition-related symptoms, and quality-of-life outcomes. We assessed the feasibility, acceptability, and usability of STRONG against a priori benchmarks.
RESULTS: Participants (N = 17) had a median age of 68 years, and 71 % were male. Feasibility benchmarks were met for participants completing the baseline assessment (94 %), completing four out of five assessments (82 %), and participant retention (85 %). Among participants who only received an oral diet during the study period, adherence to dietetic appointments (89 %) and food intake tracking (78 %) were high. Participant recruitment rate (47 %) was slightly below the benchmark (50 %). All participants found the intervention to be acceptable. Usability of the intervention was high, with 69 % and 92 % of participants reporting high satisfaction with tracking food intake through the Fitbit and the dietitian-led nutrition counseling sessions, respectively.
CONCLUSION: Our study demonstrated that STRONG could be implemented with high feasibility, acceptability, and usability for esophageal and GEJ cancer patients. Findings from this study can guide a future efficacy study to assess the impact of STRONG on patient outcomes.
CLINICAL TRIAL REGISTRATION: The Support Through Remote Observation and Nutrition Guidance Program for Gastroesophageal Cancer Patients (STRONG-GEC) study was registered on clinicaltrials.gov (NCT05438940) in June 2022 prior to participant enrollment.
METHODS: Participants received five nutritional counseling sessions with a dietitian, logged daily food intake through the Fitbit app, and completed five study assessments related to patient malnutrition, nutrition-related symptoms, and quality-of-life outcomes. We assessed the feasibility, acceptability, and usability of STRONG against a priori benchmarks.
RESULTS: Participants (N = 17) had a median age of 68 years, and 71 % were male. Feasibility benchmarks were met for participants completing the baseline assessment (94 %), completing four out of five assessments (82 %), and participant retention (85 %). Among participants who only received an oral diet during the study period, adherence to dietetic appointments (89 %) and food intake tracking (78 %) were high. Participant recruitment rate (47 %) was slightly below the benchmark (50 %). All participants found the intervention to be acceptable. Usability of the intervention was high, with 69 % and 92 % of participants reporting high satisfaction with tracking food intake through the Fitbit and the dietitian-led nutrition counseling sessions, respectively.
CONCLUSION: Our study demonstrated that STRONG could be implemented with high feasibility, acceptability, and usability for esophageal and GEJ cancer patients. Findings from this study can guide a future efficacy study to assess the impact of STRONG on patient outcomes.
CLINICAL TRIAL REGISTRATION: The Support Through Remote Observation and Nutrition Guidance Program for Gastroesophageal Cancer Patients (STRONG-GEC) study was registered on clinicaltrials.gov (NCT05438940) in June 2022 prior to participant enrollment.