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Trial Title:
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
NCT ID:
NCT06497569
Condition:
GastroEsophageal Cancer
Conditions: Keywords:
Nutrition Support
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
To reduce risk of bias, only assessors unaware of randomization status will be used to
assess study outcomes.
Intervention:
Intervention type:
Behavioral
Intervention name:
Dietitian Consultation
Description:
Participants will meet with a dietitian who will provide individualized nutrition
counseling and dietary goals for calorie and protein intake.
Bi-weekly, 30-minute dietitian telehealth visits will be conducted via ZOOM
videoconferencing at the pre-intervention baseline visit, monthly during the intervention
period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.
Arm group label:
STRONG Intervention
Arm group label:
Usual Care Intervention
Intervention type:
Behavioral
Intervention name:
Survey
Description:
Surveys will be conducted using the PG-SGA short form19-21 and a brief symptom assessment
tool that captures additional nutrition-impact symptoms not captured by the PG-SGA (e.g.,
swallowing difficulty) measured by the FACT Esophageal and Gastric Cancer scales and the
FAACT anorexia/cachexia scales 22,23 through REDCap.
Surveys are completed at the pre-intervention baseline visit and monthly during the
intervention period prior to the dietitian visits (up to 90 days), and at the 4 and 6
month timepoints post-intervention.
Arm group label:
STRONG Intervention
Arm group label:
Usual Care Intervention
Intervention type:
Behavioral
Intervention name:
Fitbit Data Collection
Description:
Participants will log food intake while sharing their data with a dietitian during the
30-minute dietitian telehealth visits at the pre-intervention baseline visit, monthly
during the intervention period (up to 90 days) and at the 4 and 6 month timepoints
post-intervention.
Arm group label:
STRONG Intervention
Intervention type:
Behavioral
Intervention name:
Referral to Dietitian
Description:
Usual Care condition referral to a dietitian based on physician discretion.
Arm group label:
Usual Care Intervention
Intervention type:
Behavioral
Intervention name:
Social Determinants of Health Survey (SDOH)
Description:
Participants will complete a SDOH Survey that captures individual-level factors
(insurance type, preferred language, educational attainment, annual household income,
digital health literacy, financial toxicity, and self-reported barriers to care [e.g.,
transportation]) and structural-level factors (neighborhood disadvantage, rural
residence).
Digital health literacy will be measured using the validated eHEALS scale, an 8-item
measure assessing confidence with finding, evaluating, and applying electronic
information to inform health decision-making (score ≤ 30 indicates low literacy).
Arm group label:
STRONG Intervention
Summary:
The purpose of this study is to determine how the STRONG intervention compares with usual
care for reducing malnutrition among gastroesophageal cancer patients.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emma Hume
Phone:
813-745-6426
Email:
Emma.Hume@moffitt.org
Investigator:
Last name:
Kea Turner, PhD, MPH, MA
Email:
Principal Investigator
Investigator:
Last name:
Jose Pimiento, MD
Email:
Principal Investigator
Start date:
June 17, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06497569
http://www.moffitt.org/clinical-trials-research/clinical-trials/
