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OpenTrials
Completed

NCT Number: NCT05438940

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

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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Key information

Conditions

GastroEsophageal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fitbit Data Collection

Behavioral

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

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.

Primary outcomes

  1. Recruitment Rate - Feasibility

    Time frame: 12 Months

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

  2. 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

  3. Data Collection - Feasibility

    Time frame: 12 Months

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

  4. 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).

  5. 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

  1. Participant Compliance with Dietician Visit - Intervention adherence

    Time frame: 12 Months

    Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician for 4/6 visits

  2. Participant Compliance with Dietary Log - Intervention adherence

    Time frame: 12 Months

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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Acronym: STRONG-GEC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 30, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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