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2022-12-21
2025-11-22
2026-05
80
NCT05675059
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
INTERVENTIONAL
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
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.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-12-09 | N/A | 2025-07-31 |
2022-12-21 | N/A | 2025-08-01 |
2023-01-09 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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
BEHAVIORAL: Daily Food Intake Diary with Fitbit Smartphone application
BEHAVIORAL: Questionnaires
|
| 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
BEHAVIORAL: Daily Food Intake Diary with Fitbit Smartphone application
BEHAVIORAL: Questionnaires
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | at 12 weeks |
| 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. | at 16 weeks |
| 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. | Up to 90 days |
| 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. | at 16 weeks |
| 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. | at 16 weeks |
| 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. | at 16 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
