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.

Study Overview

• Status: Completed
• 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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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 dietician

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 scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.; 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.

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Canopy Cancer Collective
• Investigators: Principal Investigator: Pamela Hodul, MD, Moffitt Cancer Center; Principal Investigator: Amir Alishahi Tabriz, MD, PhD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Search

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): October 16, 2024
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Nutritional Support
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavioral Disciplines and Activities; Psychological Tests; Surveys and Questionnaires; Patient Health Questionnaire
• Other Study ID Numbers: MCC-21795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No