Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Cancer
• Interventions: Behavioral: Fitbit Data Collection; Behavioral: Nutrition Counseling; Behavioral: Fact G Survey; Behavioral: General Anxiety Disorder (GAD)-7; Behavioral: Patient Health Questionnaire (PHQ)-9

• Registration Number: NCT05438927
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2022-07-15
• Primary Completion: 2024-10-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritional Support	Fitbit Data Collection	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
Nutritional Support	Nutrition Counseling	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
Nutritional Support	Fact G Survey	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
Nutritional Support	General Anxiety Disorder (GAD)-7	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
Nutritional Support	Patient Health Questionnaire (PHQ)-9	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

Primary Outcome Measures

Name	Time	Method
Participant Rating on Ease of Use for the Mobile Application - Usability	12 Months	The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake
Data Collection - Feasibility	12 Months	The study will be deemed feasible if ≥ 50% of participants submit study assessments
Recruitment Rate - Feasibility	12 Months	The study will be deemed feasible if ≥ 50% of eligible participants are recruited

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States