Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
NCT ID: NCT05438927
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2022-07-15
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
Fitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Nutrition Counseling
Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth
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.
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.
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.
Interventions
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Fitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Nutrition Counseling
Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Canopy Cancer Collective
UNKNOWN
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Amir Alishahi Tabriz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Pamela Hodul, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Related Links
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Moffitt Cancer Center Clinical Trials Search
Other Identifiers
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MCC-21795
Identifier Type: -
Identifier Source: org_study_id
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