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

GastroEsophageal Cancer Clinical Trial

— STRONG-GEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438940
• Other study ID #: MCC-21889
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Emma Hume
• Phone: 813-745-6426
• Email: Emma.Hume[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• GastroEsophageal Cancer

Intervention

Behavioral:
• Fitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
• Nutrition Counseling
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth
• Survey
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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate - Feasibility	The study will be deemed feasible if = 50% of eligible participants are enrolled	12 Months
Primary	Retention Rate - Feasibility	The study will be deemed feasible if = 70% of participants enrolled at baseline will be retained at 8 weeks	12 Months
Primary	Data Collection - Feasibility	The study will be deemed feasible if = 60% of participants submit 3/4 study assessments	12 Months
Primary	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
Primary	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	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	12 Months
Secondary	Participant Compliance with Dietary Log - Intervention adherence	Intervention adherence will be deemed successful if = 60% of participants track food intake for 8/12 weeks	12 Months

External Links

•   Moffitt Cancer Center Clinical Trial Search