Early Supportive Care And Nutritional Support In Adults With Pancreatic Cancer

Study Overview

Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

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.

N/A

Pancreatic Cancer

BEHAVIORAL: Fitbit Data Collection
BEHAVIORAL: Nutrition Counseling
BEHAVIORAL: Fact G Survey
BEHAVIORAL: General Anxiety Disorder (GAD)-7
BEHAVIORAL: Patient Health Questionnaire (PHQ)-9

MCC-21795

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-06-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-12
First Submitted that Met QC Criteria 2022-06-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-13
First Posted (ACTUAL) 2022-06-30	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nutritional Support 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 dieticia	BEHAVIORAL: Fitbit Data Collection Participants will log food intake while sharing their data with a dietician in real time for 12 weeks BEHAVIORAL: Nutrition Counseling Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth BEHAVIORAL: Fact G Survey 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 scal BEHAVIORAL: General Anxiety Disorder (GAD)-7 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. BEHAVIORAL: Patient Health Questionnaire (PHQ)-9 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Nutritional Support

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 dieticia

BEHAVIORAL: Fitbit Data Collection

Participants will log food intake while sharing their data with a dietician in real time for 12 weeks

BEHAVIORAL: Nutrition Counseling

Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth

BEHAVIORAL: Fact G Survey

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 scal

BEHAVIORAL: General Anxiety Disorder (GAD)-7

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.

BEHAVIORAL: Patient Health Questionnaire (PHQ)-9

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.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

≥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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Canopy Cancer Collective

Investigators

PRINCIPAL_INVESTIGATOR: Amir Alishahi Tabriz, MD, PhD, Moffitt Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record