Clinical trial NCT06497569: Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
Official title: Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GastroEsophageal Cancer
Keywords: Nutrition Support
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.


Eligibility criteria: Inclusion Criteria:

* Participants must be 18 years of age or older
* Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)
* Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt
* Participants must be able to speak and read Spanish and/or English
* Participants must be able to provide informed consent

Exclusion Criteria:

* Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)
* Use of feeding tubes at the time of study enrollment

Primary outcomes:
measure: Recruitment Rate- Feasibility
timeFrame: Up to 48 Months
measure: Retention Rate- Feasibility
timeFrame: Up to 90 Days
measure: Patient-reported outcome completion-Feasibility
timeFrame: Up to 6 Months
measure: Food Log Data Collection-Feasibility
timeFrame: Up to 6 Months
measure: Adherence to Dietitian Visits- Feasibility
timeFrame: Up to 6 Months
measure: Fidelity to Study Protocol- Feasibility
timeFrame: Up to 6 Months
measure: Patient Rating of MyPlate app-Feasibility
timeFrame: Up to 6 Months
measure: Participant Satisfaction- Acceptability
timeFrame: Up to 6 Months
Secondary outcomes:
measure: Malnutrition -Nutritional Status
timeFrame: Baseline, 3 Months, 6 Months
measure: Malnutrition-Significant weight loss
timeFrame: Baseline, 3 Months, 6 Months
measure: Malnutrition - Low BMI
timeFrame: Baseline, 3 Months, 6 Months
measure: Malnutrition - Low Skeletal Muscle Mass
timeFrame: Baseline, 3 Months, 6 Months
measure: Quality of Life Questionnaires
timeFrame: Baseline, 3 Months, 6 Months
measure: Treatment Adherence
timeFrame: Baseline, 3 Months, 6 Months
measure: Progression Free Survival (PFS)
timeFrame: Up to 48 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Moffitt Cancer Center
name: Amir Alishahi Tabriz, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Jose Pimiento, MD
role: PRINCIPAL_INVESTIGATOR
References: