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

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

Sponsors

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

Source H. Lee Moffitt Cancer Center and Research Institute
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

Overall Status Recruiting
Start Date 2022-06-21
Completion Date 2023-07-01
Primary Completion Date 2023-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Recruitment Rate - Feasibility 12 Months
Retention Rate - Feasibility 12 Months
Data Collection - Feasibility 12 Months
Participant Satisfaction - Acceptability 12 Months
Participant Rating on Ease of Use the Mobile Application - Usability 12 Months
Secondary Outcome
Measure Time Frame
Participant Compliance with Dietician Visit - Intervention adherence 12 Months
Participant Compliance with Dietary Log - Intervention adherence 12 Months
Enrollment 20
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Fitbit Data Collection

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

Arm Group Label: STRONG-GEC

Intervention Type: Behavioral

Intervention Name: Nutrition Counseling

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

Arm Group Label: STRONG-GEC

Intervention Type: Behavioral

Intervention Name: Survey

Description: 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.

Arm Group Label: STRONG-GEC

Eligibility

Criteria:

Inclusion Criteria: - ≥18 years old - GEC diagnosis - Planned to initiate chemoradiation (either sequentially or concurrently) with a plan for surgery 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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Alina Hoehn

Phone: 813-745-7639

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Moffitt Cancer Center Alina Hoehn 813-745-7639 [email protected] Kea Turner, PhD Principal Investigator Jose M Pimiento, MD Principal Investigator Rutika Mehta, MD, MPH Sub-Investigator Jessica Frakes, MD Sub-Investigator Sarah E Hoffe, MD Sub-Investigator Jason B Fleming, MD Sub-Investigator Jenny Permuth, PhD Sub-Investigator Mohammed Al-Jumayli, MD Sub-Investigator Brian Gonzalez, PhD Sub-Investigator Nate Parker, PhD Sub-Investigator
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: STRONG-GEC

Type: Experimental

Description: 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.

Acronym STRONG-GEC
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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