Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
- Conditions
- GastroEsophageal Cancer
- Interventions
- Behavioral: Dietitian ConsultationBehavioral: SurveyBehavioral: Fitbit Data CollectionBehavioral: Referral to DietitianBehavioral: Social Determinants of Health Survey (SDOH)
- Registration Number
- NCT06497569
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STRONG Intervention Survey Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. Usual Care Intervention Survey Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. STRONG Intervention Dietitian Consultation Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. STRONG Intervention Fitbit Data Collection Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. Usual Care Intervention Dietitian Consultation Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. STRONG Intervention Social Determinants of Health Survey (SDOH) Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. Usual Care Intervention Referral to Dietitian Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
- Primary Outcome Measures
Name Time Method Recruitment Rate- Feasibility Up to 48 Months The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.
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.
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 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).
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).
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.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
- Secondary Outcome Measures
Name Time Method 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.
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 -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).
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).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.
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.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).
Trial Locations
- Locations (2)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States