Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients

March 18, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Pamela Hodul, MD
        • Sub-Investigator:
          • Jason Fleming, MD, FACS
        • Sub-Investigator:
          • Sarah Hoffe, MD
        • Sub-Investigator:
          • Dae Won Kim, MD
        • Sub-Investigator:
          • Richard Kim, MD
        • Contact:
        • Sub-Investigator:
          • Jennifer Permuth, PhD, MS
        • Principal Investigator:
          • Kea Turner, PhD
        • Sub-Investigator:
          • Brian Gonzalez, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: Questionnaires
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.
Active Comparator: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: Questionnaires
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the STRONG Program
Time Frame: at 12 weeks
Feasibility of the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed using recruitment and retention rates, along with data completion rates.
at 12 weeks
Acceptability of the STRONG Program
Time Frame: at 16 weeks
Acceptability of the STRONG Program measure uses 4 items to indicate participant satisfaction. The measure uses a scale of 0-5, 0 meaning the participant completely disagrees with the statements regarding intervention satisfaction and 5 indicating complete agreement with the statements regarding intervention satisfaction. The measure score ranges from 0-20 with 20 indicating the highest degree of satisfaction.
at 16 weeks
Participant adherence to the STRONG Program
Time Frame: Up to 90 days
will be defined as ≥ 60% of patients will meet with a dietician for 4/6 dietician visits and ≥ 60% of patients will track daily food intake via a Fitbit.
Up to 90 days
Malnutrition: Significant Weight Loss
Time Frame: at 16 weeks
Significant weight loss will be defined as a loss of >5% and >10% of body weight over the 16 week assessment period. Weight will be measured in kg.
at 16 weeks
Malnutrition: Low BMI
Time Frame: at 16 weeks
Low BMI will be calculated by combining weight (kg) and height measurements (m²) and defined as <20kg/m² for adults < 70 years old and <22kg/m² for adults ≥ 70 years old over the 16 week assessment period.
at 16 weeks
Malnutrition: Low Skeletal Muscle Mass
Time Frame: at 16 weeks
Low skeletal muscle mass will be calculated by estimating skeletal muscle index (SMI) by dividing the cross-sectional area of muscle in a single 'slice' from an abdominal CT scan (cm2) by stature (square of height in m²). Low SMI will be defined as ≤38.9 cm2/m2 for females and ≤55.4 for males over the 16 week assessment period.
at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Pancreatic Cancer Action Network

Investigators

  • Principal Investigator: Pamela Hodul, MD, Moffitt Cancer Center
  • Principal Investigator: Kea Turner, PhD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-22082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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