Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)

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 program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.

Official Title
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Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Behavioral: Fitbit Data Collection
* Behavioral: Nutrition Counseling
* Behavioral: Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old Diagnosis of pancreatic cancer Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center Discharged on an oral diet Able to speak and read English or Spanish Able to provide informed consent Exclusion Criteria: Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)

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 |
| --- | --- |
| Experimental: STRONG-PCS Intervention<br>Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person 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. | Behavioral: Fitbit Data Collection<br>* Participants will log food intake while sharing their data with a dietician in real time for 12 weeks<br>Behavioral: Nutrition Counseling<br>* Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.<br>Behavioral: Survey<br>* Participants will take a survey at baseline and weeks 4,8,& 12. (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.<br>|
| Active Comparator: Usual Care<br>Participants will be referred for nutrition counseling from a dietitian based on clinical discretion. | Behavioral: Nutrition Counseling<br>* Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.<br>Behavioral: Survey<br>* Participants will take a survey at baseline and weeks 4,8,& 12. (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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate - Feasibility | The study will be deemed feasible if ≥ 50% of eligible participants are enrolled. | Up to 48 months | 
| Retention Rate - Feasibility | The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks. | at 8 weeks | 
| Data Collection - Feasibility | The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days. | at 8 weeks | 
| 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, score >/= 12). | at 8 weeks | 
| 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, score of >/=60). | at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malnutrition-Significant weight loss | Significant weight loss is defined as >5% and >10% of body weight at 30, 60, and 90 days after discharge. This will be calculated based on weight obtained during clinic visits. | 90 days | 
| Malnutrition - Low BMI | Low BMI will be defined as <20kg/m² for individuals <70 years old and <22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits. | at Baseline, 30, 60 and 90 days | 
| Malnutrition - Low Skeletal Muscle Mass | Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline and 90 days after discharge (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.9 cm2 /m2 for females and SMI ≤55.4 cm2 /m2 for males. | At baseline, 30, 60 and 90 days | 
| Quality of Life | Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about the 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 score indicates a better quality of life. | at Baseline, 4, 8 and 12 weeks | 
| Hospital Readmissions | Hospital readmissions will be measured using a self-reported survey item to determine whether the patient was admitted to the index hospital or another hospital after hospital discharge. | 30, 60 and 90 days post-hospital discharge | 
| Malnutrition -Nutritional Status | Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, = 9 severely malnourished). | at Baseline, 30, 60 and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition Support