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

H. Lee Moffitt Cancer Center and Research Institute80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Consultations with Moffitt DieticianBEHAVIORAL

Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks.

Daily Food Intake Diary with Fitbit Smartphone applicationBEHAVIORAL

Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.

QuestionnairesBEHAVIORAL

Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.