Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

Study Overview
=================
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 and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.

Official Title
-----------------
Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Behavioral: Fitbit Data Collection
* Behavioral: Nutrition Counseling
* Behavioral: Fact G Survey
* Behavioral: General Anxiety Disorder (GAD)-7
* Behavioral: Patient Health Questionnaire (PHQ)-9


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old 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 or Spanish 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 The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Support<br>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 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, biweekly nutrition counseling from a dietician via telehealth<br>Behavioral: Fact G Survey<br>* Participants will take a survey at baseline and weeks 4,8,12 & 16. The 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>Behavioral: General Anxiety Disorder (GAD)-7<br>* Participants will take a survey at baseline and weeks 4,8,12 & 16. The questionnaire measures participants anxiety with a scale of 0=not at all, 3=Nearly everyday.<br>Behavioral: Patient Health Questionnaire (PHQ)-9<br>* Participants will take a survey at baseline and weeks 4,8,12 & 16. The questionnaire measures participants depression with a scale of 0=not at all, 3=Nearly everyday.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate - Feasibility | The study will be deemed feasible if ≥ 50% of eligible participants are recruited | 12 Months | 
| Data Collection - Feasibility | The study will be deemed feasible if ≥ 50% of participants submit study assessments | 12 Months | 
| Participant Rating on Ease of Use for 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 | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Compliance with Palliative Care Visits - Intervention Adherence | Intervention adherence will be deemed successful if ≥ 60% of participants attend recommended palliative care visits (# of visits based on provider recommendation) | 12 Months | 
| Participant Compliance with Dietician Visits - Intervention Adherence | Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician biweekly for 12 weeks | 12 Months | 
| Participant Compliance with Dietary Log - Intervention Adherence | Intervention adherence will be deemed successful if ≥ 60% of participants rack food intake for 8/12 weeks | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional Support