This clinical trial tests whether the STRONG program can help manage malnutrition and improve quality-of-life in patients with gastroesophageal cancer who are receiving chemotherapy and/or radiation treatment. Malnutrition is widely recognized as a common and distressing symptom of gastroesophageal cancer and its treatment. Malnutrition negatively impacts quality of life, treatment tolerance, and survival for these patients. The STRONG program provides individualized nutrition counseling and remote monitoring by a dietician, and may help improve nutrition outcomes and quality of life for patients with gastroesophageal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05438940.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Assess the feasibility, acceptability, and usability of remote malnutrition monitoring among gastroesophageal cancer (GEC) patients initiating chemoradiation.
II. Collect pilot data on malnutrition (weight, body mass index [BMI], muscle mass), gastrointestinal (GI) symptom burden, quality of life and treatment outcomes among GEC patients initiating chemotherapy and/or radiation.
OUTLINE:
Patients undergo individually tailored nutrition counseling from a dietician via telehealth or in-person once every 2 weeks (Q2W) for 8 weeks (5 visits) and remote monitoring through a smartphone application (app) and wearable sensor (Fitbit) to log food intake for 12 weeks. Patients receive a call/email/videoconference if they do not log any dietary intake for a period of greater than 5 days or log irregular values for daily dietary intake.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorAmir Alishahi Tabriz
