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

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Pancreatic Cancer

Treatments: Behavioral: Questionnaires; Behavioral: Consultations with Moffitt Dietician; Behavioral: Daily Food Intake Diary with Fitbit Smartphone application

Study type: Interventional

Funder types: Other

Identifiers

NCT05675059

MCC-22082

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group 1: STRONG Intervention

Active Comparator group

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.

Treatment:

Behavioral: Daily Food Intake Diary with Fitbit Smartphone application

Behavioral: Questionnaires

Behavioral: Consultations with Moffitt Dietician

Group 2: Usual Care

Active Comparator group

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.

Treatment:

Behavioral: Daily Food Intake Diary with Fitbit Smartphone application

Behavioral: Questionnaires

Behavioral: Consultations with Moffitt Dietician