Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
- Conditions
- GastroEsophageal Cancer
- Interventions
- Behavioral: Fitbit Data CollectionBehavioral: Nutrition CounselingBehavioral: Survey
- Registration Number
- NCT05438940
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 23
- ≥18 years old
- Locally advanced or metastatic GEC diagnosis
- Planned to initiate chemoradiation and/or radiation therapy with a plan to have surgery or a plan to have definitive treatment at Moffitt.
- Able to speak and read English
- Able to provide informed consent
- Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
- Undergoing concurrent treatment for a secondary primary cancer
- Use of feeding tubes before enrollment (The last exclusion criterion was included because investigators do not anticipate these participants would benefit from a dietary monitoring intervention)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description STRONG-GEC Fitbit Data Collection 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. STRONG-GEC Nutrition Counseling 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. STRONG-GEC Survey 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.
- Primary Outcome Measures
Name Time Method Participant Satisfaction - Acceptability 12 Months 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).
Data Collection - Feasibility 12 Months The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments
Recruitment Rate - Feasibility 12 Months The study will be deemed feasible if ≥ 50% of eligible participants are enrolled
Retention Rate - Feasibility 12 Months The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks
Participant Rating on Ease of Use the Mobile Application - Usability 12 Months 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).
- Secondary Outcome Measures
Name Time Method Participant Compliance with Dietary Log - Intervention adherence 12 Months Intervention adherence will be deemed successful if ≥ 60% of participants track food intake for 8/12 weeks
Participant Compliance with Dietician Visit - Intervention adherence 12 Months Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician for 4/6 visits
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States