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

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Behavioral: Consultations with Moffitt Dietician; Behavioral: Daily Food Intake Diary with Fitbit Smartphone application; Behavioral: Questionnaires

• Registration Number: NCT05675059
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study Start: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: STRONG Intervention	Daily Food Intake Diary with Fitbit Smartphone application	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.
Group 1: STRONG Intervention	Questionnaires	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.
Group 1: STRONG Intervention	Consultations with Moffitt Dietician	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.
Group 2: Usual Care	Consultations with Moffitt Dietician	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.
Group 2: Usual Care	Daily Food Intake Diary with Fitbit Smartphone application	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.
Group 2: Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Participant adherence to the STRONG Program	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.
Feasibility of the STRONG Program	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.
Acceptability of the STRONG Program	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.
Malnutrition: Significant Weight Loss	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.
Malnutrition: Low BMI	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.
Malnutrition: Low Skeletal Muscle Mass	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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States