STRONG Program for Cancer Patients

Not Applicable

Active, not recruiting

• Conditions: Gastrointestinal Cancer
• Interventions: Behavioral: Consultations with Moffitt Dietician; Behavioral: Daily Food Intake Diary with Fitbit smartphone application; Behavioral: Questionnaires

• Registration Number: NCT05649969
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastrointestinal cancer who are receiving chemotherapy and surgical treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-14
• Primary Completion: 2023-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Gastrointestinal Cancer diagnosis (e.g., colon cancer, appendiceal cancer)
• Peritoneal disease diagnosis
• Received Cytoreductive Surgery and Heated Intra-Peritoneal Chemotherapy (CRS-HIPEC) for curative intent at Moffitt
• Transitioned to an oral diet post-surgery
• 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
• Receipt of parenteral or enteral nutrition after surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STRONG Program	Consultations with Moffitt Dietician	the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
STRONG Program	Daily Food Intake Diary with Fitbit smartphone application	the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
STRONG Program	Questionnaires	the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.

Primary Outcome Measures

Name	Time	Method
Adherence to the STRONG Program	at 16 weeks	Participant adherence to the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed by Fitbit dietary log data and dietician care visit data.
Feasibility of the STRONG Program	at 12 weeks	Feasibility of the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed using recruitment and retention rates, along with data completion rates.
Acceptability of the STRONG Program	at 16 weeks	The Acceptability of the STRONG Program measure uses 4 items to indicate participant satisfaction. The measure uses a scale of 0-5, 0 meaning the participant completely disagrees with the statements regarding intervention satisfaction and 5 indicating complete agreement with the statements regarding intervention satisfaction. The measure score ranges from 0-20 with 20 indicating the highest degree of satisfaction.
Efficacy of STRONG Program on Treatment Outcomes	at 16 weeks	Efficacy of STRONG program on treatment outcomes will be measured by reviewing the Electronic Health Record for hospital readmissions and cause of readmission

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States