STRONG Program for Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Behavioral: Consultations with Moffitt Dietician
* Behavioral: Daily Food Intake Diary with Fitbit smartphone application
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STRONG Program<br>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. | Behavioral: Consultations with Moffitt Dietician<br>* Participants will have an initial consultation with a dietician and then biweekly follow-up visits (in person or virtually) for 12 weeks.<br>Behavioral: Daily Food Intake Diary with Fitbit smartphone application<br>* Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks<br>Behavioral: Questionnaires<br>* Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the STRONG Program | 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. | at 12 weeks | 
| Acceptability of the STRONG Program | 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. | at 16 weeks | 
| Adherence to the STRONG Program | 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. | at 16 weeks | 
| Efficacy of STRONG Program on Treatment Outcomes | Efficacy of STRONG program on treatment outcomes will be measured by reviewing the Electronic Health Record for hospital readmissions and cause of readmission | at 16 weeks |