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

NCT05438940 | Active Not Recruiting

• 1 other identifier: MCC-21889
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

GastroEsophageal Cancer

Keywords

Nutrition Support

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate - Feasibility

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

  12 Months

• Retention Rate - Feasibility

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

  12 Months

• Data Collection - Feasibility

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

  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).

  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).

  12 Months

Secondary Outcomes (2)

• Participant Compliance with Dietician Visit - Intervention adherence

  12 Months

• Participant Compliance with Dietary Log - Intervention adherence

  12 Months

Study Arms (1)

STRONG-GEC

EXPERIMENTAL

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.

Behavioral: Fitbit Data Collection; Behavioral: Nutrition Counseling; Behavioral: Survey

Interventions

Fitbit Data Collection BEHAVIORAL

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

STRONG-GEC

Nutrition Counseling BEHAVIORAL

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

STRONG-GEC

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.

STRONG-GEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Lin YC, Pimiento JM, Milano J, Riccardi D, Mckinnie N, Hume E, Sprow O, Diaz-Carraway S, Budnetz M, Hagen R, Al-Jumayli M, Pereira AL, Sinnamon AJ, Somasundaram A, Permuth JB, Tabriz AA, Turner K. Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer. Contemp Clin Trials Commun. 2024 Dec 23;43:101421. doi: 10.1016/j.conctc.2024.101421. eCollection 2025 Feb.

  PMID: 39810840 DERIVED

Related Links

• Moffitt Cancer Center Clinical Trial Search

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kea Turner, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Jose M Pimiento, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: July 15, 2022
• Primary Completion: June 4, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)