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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STRONG Intervention | Experimental | 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. |
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| Usual Care Intervention | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietitian Consultation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate- Feasibility | The Study will be deemed feasible ≥ 50% of eligible patients are enrolled. | 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. | 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. | 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). | 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. | 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 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 3 Months, 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Hume | Contact | 813-745-6426 | Emma.Hume@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Amir Alishahi Tabriz, MD, PhD, MPH | Moffitt Cancer Center | Principal Investigator |
| Jose Pimiento, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41457289 | Derived | Turner K, Somasundaram A, Small BJ, Milano J, Santiago C, Sprow O, Hume E, Khajoueinejad N, McKinnie N, Pereira AL, Sinnamon A, Permuth JB, Tabriz AA, Pimiento JM. A patient-mediated implementation strategy to improve nutrition care delivery for esophageal and gastric cancer: a study protocol for a pilot randomized controlled trial. J Health Popul Nutr. 2025 Dec 28;45(1):37. doi: 10.1186/s41043-025-01208-3. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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To reduce risk of bias, only assessors unaware of randomization status will be used to assess study outcomes.
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| Survey | Behavioral | 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. |
|
| Fitbit Data Collection | Behavioral | 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. |
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| Referral to Dietitian | Behavioral | Usual Care condition referral to a dietitian based on physician discretion. |
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| Social Determinants of Health Survey (SDOH) | Behavioral | 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). |
|
| Up to 6 Months |
| Participant Satisfaction- Acceptability | 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. | Up to 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. |
| 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. | 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. | 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. | 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). | 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). | Up to 48 Months |
| UNC Lineberger Comprehensive Cancer Center | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
|
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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