GastroEsophageal Cancer
Conditions
Keywords
Nutrition Support
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.
Interventions
BEHAVIORALDietitian Consultation
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.
BEHAVIORALSurvey
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.
BEHAVIORALFitbit Data Collection
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.
BEHAVIORALReferral to Dietitian
Usual Care condition referral to a dietitian based on physician discretion.
BEHAVIORALSocial Determinants of Health Survey (SDOH)
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).
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate- Feasibility | Up to 48 Months | The Study will be deemed feasible ≥ 50% of eligible patients are enrolled. |
| Retention Rate- Feasibility | Up to 90 Days | The Study will be deemed feasible if ≥ 70% of participants enrolled at baseline are retained at the end of the intervention period. |
| Patient-reported outcome completion-Feasibility | Up to 6 Months | The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments. |
| Food Log Data Collection-Feasibility | Up to 6 Months | The study will be deemed feasible if ≥ 70% of participants enrolled log food for greater than 80% of study days (72 out of 90). |
| Adherence to Dietitian Visits- Feasibility | Up to 6 Months | The Study will be deemed feasible if ≥ 70% of participants enrolled attend 4 out of 6 dietitian visits. |
| Fidelity to Study Protocol- Feasibility | Up to 6 Months | The Study will be deemed feasible if 20% of randomly audited dietitian visits have documented PG-SGA and calorie and protein goals |
| Patient Rating of MyPlate app-Feasibility | Up to 6 Months | The Study will be deemed feasible if ≥ 70% of participants rate the MyPlate app as east-to use utilizing a validated usability scale (score ≥ 60). |
| Participant Satisfaction- Acceptability | Up to 6 Months | Patient satisfaction with the intervention will be deemed acceptable if ≥ 70% of participants rate the intervention as satisfactory utilizing a validated 4 item scale (score range 0-20). A cutoff score of ≥ 12 based on prior studies to define intervention acceptability will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Malnutrition -Nutritional Status | Baseline, 3 Months, 6 Months | Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, ≥ 9 severely malnourished). |
| Malnutrition-Significant weight loss | Baseline, 3 Months, 6 Months | Significant weight loss is defined as \>5% and \>10% of body weight. This will be calculated based on weight obtained during clinic visits. |
| Malnutrition - Low BMI | Baseline, 3 Months, 6 Months | Low BMI will be defined as \<20kg/m² for individuals \<70 years old and \<22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits. |
| Malnutrition - Low Skeletal Muscle Mass | Baseline, 3 Months, 6 Months | Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline, 3 months and 6 months (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.5 cm2 /m2 for females and SMI ≤52.4 cm2 /m2 for males. |
| Quality of Life Questionnaires | Baseline, 3 Months, 6 Months | Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Scale and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) subscales. (FACT-G) and (FAACT) Questionnaires include questions about the participant's physical, social, emotional and functional well-being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher score indicates a better quality of life. |
| Treatment Adherence | Baseline, 3 Months, 6 Months | Treatment Adherence will be measured by obtaining scheduling and electronic health record (EHR) data to estimate adherence to chemotherapy and/or radiation therapy. Comparison of will be made of planned vs. received chemotherapy and/or radiation regimens to define 1) treatment delay (yes/no); 2) dose reduction (yes/no); and 3) treatment discontinuation (yes/no). We will also document receipt of surgery (yes/no). |
| Progression Free Survival (PFS) | Up to 48 Months | Progression Free Survival (PFS) status will be obtained from the cancer center registry to estimate overall survival (the time from random assignment to death from any cause) and progression-free survival (the time from random assignment to disease progression or death from any cause). |
Countries
United States
Contacts
CONTACTEmma Hume
PRINCIPAL_INVESTIGATORAmir Alishahi Tabriz, MD, PhD, MPH
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORJose Pimiento, MD
Moffitt Cancer Center
Outcome results
None listed