Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- GastroEsophageal Cancer
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Participant Satisfaction - Acceptability
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Participant Satisfaction - Acceptability
Time Frame: 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
Time Frame: 12 Months
The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments
Recruitment Rate - Feasibility
Time Frame: 12 Months
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled
Retention Rate - Feasibility
Time Frame: 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
Time Frame: 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 Outcomes
- Participant Compliance with Dietary Log - Intervention adherence(12 Months)
- Participant Compliance with Dietician Visit - Intervention adherence(12 Months)