The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
80
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.
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.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGUNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
RECRUITINGRecruitment Rate- Feasibility
The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.
Time frame: Up to 48 Months
Retention Rate- Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled at baseline are retained at the end of the intervention period.
Time frame: Up to 90 Days
Patient-reported outcome completion-Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments.
Time frame: Up to 6 Months
Food Log Data Collection-Feasibility
The study will be deemed feasible if ≥ 70% of participants enrolled log food for greater than 80% of study days (72 out of 90).
Time frame: Up to 6 Months
Adherence to Dietitian Visits- Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled attend 4 out of 6 dietitian visits.
Time frame: Up to 6 Months
Fidelity to Study Protocol- Feasibility
The Study will be deemed feasible if 20% of randomly audited dietitian visits have documented PG-SGA and calorie and protein goals
Time frame: Up to 6 Months
Patient Rating of MyPlate app-Feasibility
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).
Time frame: Up to 6 Months
Participant Satisfaction- Acceptability
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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.
Usual Care condition referral to a dietitian based on physician discretion.
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).
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.
Time frame: Up to 6 Months
Malnutrition -Nutritional Status
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).
Time frame: Baseline, 3 Months, 6 Months
Malnutrition-Significant weight loss
Significant weight loss is defined as \>5% and \>10% of body weight. This will be calculated based on weight obtained during clinic visits.
Time frame: Baseline, 3 Months, 6 Months
Malnutrition - Low BMI
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.
Time frame: Baseline, 3 Months, 6 Months
Malnutrition - Low Skeletal Muscle Mass
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.
Time frame: Baseline, 3 Months, 6 Months
Quality of Life Questionnaires
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.
Time frame: Baseline, 3 Months, 6 Months
Treatment Adherence
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).
Time frame: Baseline, 3 Months, 6 Months
Progression Free Survival (PFS)
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).
Time frame: Up to 48 Months