Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
NCT ID: NCT05675059
Last Updated: 2025-11-14
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
80 participants
INTERVENTIONAL
2022-12-21
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group 1: STRONG Intervention
The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
Consultations with Moffitt Dietician
Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks.
Daily Food Intake Diary with Fitbit Smartphone application
Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.
Questionnaires
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.
Group 2: Usual Care
Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level.
Consultations with Moffitt Dietician
Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks.
Daily Food Intake Diary with Fitbit Smartphone application
Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.
Questionnaires
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.
Interventions
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Consultations with Moffitt Dietician
Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks.
Daily Food Intake Diary with Fitbit Smartphone application
Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.
Questionnaires
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
* Receiving chemotherapy under the guidance of Moffitt
* Able to speak and read English
* Able to provide informed consent
Exclusion Criteria
* Undergoing concurrent treatment for a second primary GI cancer
* ECOG status of 2 or greater
* Use of parenteral or enteral nutrition
* Presence of malignant ascites
18 Years
ALL
No
Sponsors
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Pancreatic Cancer Action Network
OTHER
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, MPH
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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References
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Turner K, Kim DW, Gonzalez BD, Gore LR, Gurd E, Milano J, Riccardi D, Byrne M, Al-Jumayli M, de Castria TB, Laber DA, Hoffe S, Costello J, Robinson E, Chadha JS, Rajasekhara S, Hume E, Hagen R, Nguyen OT, Nardella N, Parker N, Carson TL, Tabriz AA, Hodul P. Support Through Remote Observation and Nutrition Guidance (STRONG), a digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2024 Feb 23;38:101271. doi: 10.1016/j.conctc.2024.101271. eCollection 2024 Apr.
Other Identifiers
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MCC-22082
Identifier Type: -
Identifier Source: org_study_id