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Trial Title:
Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)
NCT ID:
NCT06001268
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Nutrition Support
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:
Fitbit Data Collection
Description:
Participants will log food intake while sharing their data with a dietician in real time
for 12 weeks
Arm group label:
STRONG-PCS Intervention
Intervention type:
Behavioral
Intervention name:
Nutrition Counseling
Description:
Participants will receive individually tailored, bi-weekly nutrition counseling from a
dietician via telehealth or in person.
Arm group label:
STRONG-PCS Intervention
Arm group label:
Usual Care
Intervention type:
Behavioral
Intervention name:
Survey
Description:
Participants will take a survey at baseline and weeks 4,8,& 12. (FACT-G) 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.
Arm group label:
STRONG-PCS Intervention
Arm group label:
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 program. The program
provides enhanced dietician access and nutrition support for participants living with
pancreatic cancer who are undergoing surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥18 years old
- Diagnosis of pancreatic cancer
- Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy,
total pancreatectomy) for treatment at Moffitt Cancer Center
- Discharged on an oral diet
- Able to speak and read English or Spanish
- Able to provide informed consent
Exclusion Criteria:
- Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)
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:
Kea L Turner, PhD, MPH, MA
Email:
Principal Investigator
Investigator:
Last name:
Pamela J Hodul, MD
Email:
Principal Investigator
Investigator:
Last name:
Amir Alishahi Tabriz, MD, PhD, MPH
Email:
Sub-Investigator
Investigator:
Last name:
Brian D Gonzalez, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Nate H Parker, MPH, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Laurence R Gore, PhD
Email:
Sub-Investigator
Start date:
August 14, 2023
Completion date:
August 2027
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
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/NCT06001268
https://www.moffitt.org/clinical-trials-research/clinical-trials/
