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The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STRONG-GEC | Experimental | Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit Data Collection | Behavioral | Participants will log food intake while sharing their data with a dietician in real time for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate - Feasibility | The study will be deemed feasible if ≥ 50% of eligible participants are enrolled | 12 Months |
| Retention Rate - Feasibility | The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks | 12 Months |
| Data Collection - Feasibility | The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments | 12 Months |
| Participant Satisfaction - Acceptability | The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20). | 12 Months |
| Participant Rating on Ease of Use the Mobile Application - Usability | The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100). | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Compliance with Dietician Visit - Intervention adherence | Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician for 4/6 visits | 12 Months |
| Participant Compliance with Dietary Log - Intervention adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kea Turner, PhD | Moffitt Cancer Center | Principal Investigator |
| Jose M Pimiento, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39810840 | Derived | Lin YC, Pimiento JM, Milano J, Riccardi D, Mckinnie N, Hume E, Sprow O, Diaz-Carraway S, Budnetz M, Hagen R, Al-Jumayli M, Pereira AL, Sinnamon AJ, Somasundaram A, Permuth JB, Tabriz AA, Turner K. Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer. Contemp Clin Trials Commun. 2024 Dec 23;43:101421. doi: 10.1016/j.conctc.2024.101421. eCollection 2025 Feb. |
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| Nutrition Counseling | Behavioral | Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth |
|
| Survey | Behavioral | Participants will take a survey at baseline and weeks 4,8,12 & 16. (FACT-G) Questionnaire includes questions about 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 total score indicates better quality of life. |
|
Intervention adherence will be deemed successful if ≥ 60% of participants track food intake for 8/12 weeks |
| 12 Months |
| 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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