Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Pancreatic Cancer

Treatments: Behavioral: General Anxiety Disorder (GAD)-7; Behavioral: Fitbit Data Collection; Behavioral: Fact G Survey; Behavioral: Nutrition Counseling; Behavioral: Patient Health Questionnaire (PHQ)-9

Study type: Interventional

Funder types: Other

Identifiers

NCT05438927

MCC-21795

Details and patient eligibility

About

The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old
• 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 or Spanish
• 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
• The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Nutritional Support

Experimental group

Description:

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing data with a dietician

Treatment:

Behavioral: Patient Health Questionnaire (PHQ)-9

Behavioral: Fact G Survey

Behavioral: Nutrition Counseling

Behavioral: Fitbit Data Collection

Behavioral: General Anxiety Disorder (GAD)-7