Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients

N/AActive Not RecruitingNCT05438940

H. Lee Moffitt Cancer Center and Research Institute23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

GastroEsophageal Cancer

Interventions

Fitbit Data CollectionBEHAVIORAL

Participants will log food intake while sharing their data with a dietician in real time for 12 weeks

Nutrition CounselingBEHAVIORAL

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth

SurveyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

Recruitment Rate - Feasibility

The study will be deemed feasible if ≥ 50% of eligible participants are enrolled

Time frame: 12 Months

Retention Rate - Feasibility

The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks

Time frame: 12 Months

Data Collection - Feasibility

The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments

Time frame: 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).

Time frame: 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).

Time frame: 12 Months

Secondary Outcomes

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

Time frame: 12 Months

Participant Compliance with Dietary Log - Intervention adherence

Intervention adherence will be deemed successful if ≥ 60% of participants track food intake for 8/12 weeks

Data from ClinicalTrials.gov

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