Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic 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 enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy.

Official Title
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Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients

Conditions
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Pancreatic 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: 18 years of age or older Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer Planning to initiate chemotherapy under the guidance of 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 second primary GI cancer ECOG status of 2 or greater Receipt of chemotherapy in the past 6 months for recurrent pancreatic cancer Use of parenteral or enteral nutrition Presence of malignant ascites

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: STRONG Intervention<br>The STRONG program includes consultation with a Moffit 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 and then biweekly follow-up visits (in-person or virtually) with a study dietician 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 app and wearing a Fitbit for 12 weeks.<br>Behavioral: Questionnaires<br>* Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.<br>|
| Active Comparator: Group 2: Usual Care<br>Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level. | Behavioral: Consultations with Moffitt Dietician<br>* Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician 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 app and wearing a Fitbit for 12 weeks.<br>Behavioral: Questionnaires<br>* Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.<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 | 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 | 
| Participant adherence to the STRONG Program | will be defined as ≥ 60% of patients will meet with a dietician for 4/6 dietician visits and ≥ 60% of patients will track daily food intake via a Fitbit. | Up to 90 days | 
| Malnutrition: Significant Weight Loss | Significant weight loss will be defined as a loss of >5% and >10% of body weight over the 16 week assessment period. Weight will be measured in kg. | at 16 weeks | 
| Malnutrition: Low BMI | Low BMI will be calculated by combining weight (kg) and height measurements (m²) and defined as <20kg/m² for adults < 70 years old and <22kg/m² for adults ≥ 70 years old over the 16 week assessment period. | at 16 weeks | 
| Malnutrition: Low Skeletal Muscle Mass | Low skeletal muscle mass will be calculated by estimating skeletal muscle index (SMI) by dividing the cross-sectional area of muscle in a single 'slice' from an abdominal CT scan (cm2) by stature (square of height in m²). Low SMI will be defined as ≤38.9 cm2/m2 for females and ≤55.4 for males over the 16 week assessment period. | at 16 weeks |