Back to resultsSupport Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
Primary Purpose
Pancreatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Consultations with Moffitt Dietician
Daily Food Intake Diary with Fitbit Smartphone application
Questionnaires
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer
Eligibility Criteria
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
Sites / Locations
- Moffitt Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1: STRONG Intervention
Group 2: Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Feasibility of the STRONG Program
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.
Acceptability of the STRONG Program
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.
Participant adherence to the STRONG Program
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.
Malnutrition: Significant Weight Loss
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.
Malnutrition: Low BMI
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.
Malnutrition: Low Skeletal Muscle Mass
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05675059
First Posted
December 9, 2022
Last Updated
October 17, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Pancreatic Cancer Action Network
1. Study Identification
Unique Protocol Identification Number
NCT05675059
Brief Title
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
Official Title
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Pancreatic Cancer Action Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: STRONG Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Consultations with Moffitt Dietician
Intervention Description
Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Daily Food Intake Diary with Fitbit Smartphone application
Intervention Description
Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Intervention Description
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.
Primary Outcome Measure Information:
Title
Feasibility of the STRONG Program
Description
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.
Time Frame
at 12 weeks
Title
Acceptability of the STRONG Program
Description
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.
Time Frame
at 16 weeks
Title
Participant adherence to the STRONG Program
Description
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.
Time Frame
Up to 90 days
Title
Malnutrition: Significant Weight Loss
Description
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.
Time Frame
at 16 weeks
Title
Malnutrition: Low BMI
Description
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.
Time Frame
at 16 weeks
Title
Malnutrition: Low Skeletal Muscle Mass
Description
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.
Time Frame
at 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kea Turner, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela Hodul, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Hume
Phone
813-745-6426
Email
Emma.Hume@moffitt.org
First Name & Middle Initial & Last Name & Degree
Kea Turner, PhD
First Name & Middle Initial & Last Name & Degree
Pamela Hodul, MD
First Name & Middle Initial & Last Name & Degree
Jason Fleming, MD, FACS
First Name & Middle Initial & Last Name & Degree
Brian Gonzalez, PhD
First Name & Middle Initial & Last Name & Degree
Sarah Hoffe, MD
First Name & Middle Initial & Last Name & Degree
Dae Won Kim, MD
First Name & Middle Initial & Last Name & Degree
Richard Kim, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Permuth, PhD, MS
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.moffitt.org/clinical-trials-research/clinical-trials/
Description
Moffitt Cancer Center Clinical Trials website
Learn more about this trial
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
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