GastroEsophageal Cancer
Conditions
Keywords
Nutrition Support
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
Interventions
BEHAVIORALFitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
BEHAVIORALNutrition Counseling
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth
BEHAVIORALSurvey
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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Data Collection - Feasibility | 12 Months | The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKea Turner, PhD
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORJose M Pimiento, MD
Moffitt Cancer Center
Outcome results
None listed