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Trial Title:
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
NCT ID:
NCT05675059
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Consultations with Moffitt Dietician
Description:
Participants will have an initial consultation and then biweekly follow-up visits
(in-person or virtually) with a study dietician for 12 weeks.
Arm group label:
Group 1: STRONG Intervention
Arm group label:
Group 2: Usual Care
Intervention type:
Behavioral
Intervention name:
Daily Food Intake Diary with Fitbit Smartphone application
Description:
Participants will keep a daily diary of food intake with a Fitbit smartphone app and
wearing a Fitbit for 12 weeks.
Arm group label:
Group 1: STRONG Intervention
Arm group label:
Group 2: Usual Care
Intervention type:
Behavioral
Intervention name:
Questionnaires
Description:
Participants will complete a questionnaire electronically at baseline and again at 4, 8,
12 and 16 weeks.
Arm group label:
Group 1: STRONG Intervention
Arm group label:
Group 2: Usual Care
Summary:
The purpose of the study is to assess the feasibility and participant satisfaction with
the Support through Remote Observation and Nutrition Guidance (STRONG) program. The
program provides enhanced dietician access and nutrition support for participants living
with pancreatic cancer who are receiving chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years of age or older
- 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:
- 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
- Use of parenteral or enteral nutrition
- Presence of malignant ascites
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emma Hume
Phone:
813-745-6426
Email:
Emma.Hume@moffitt.org
Investigator:
Last name:
Amir Alishahi Tabriz, MD, PhD, MPH
Email:
Principal Investigator
Investigator:
Last name:
Pamela Hodul, MD
Email:
Principal Investigator
Investigator:
Last name:
Jason Fleming, MD, FACS
Email:
Sub-Investigator
Investigator:
Last name:
Brian Gonzalez, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Sarah Hoffe, MD
Email:
Sub-Investigator
Investigator:
Last name:
Dae Won Kim, MD
Email:
Sub-Investigator
Investigator:
Last name:
Richard Kim, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jennifer Permuth, PhD, MS
Email:
Sub-Investigator
Start date:
December 21, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
Pancreatic Cancer Action Network
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05675059
https://www.moffitt.org/clinical-trials-research/clinical-trials/
