Support through Remote Observation and Nutrition Guidance Program for Improving Nutritional Support in Patients with Locally Advanced, Metastatic and Resectable or Borderline Resectable Pancreatic Cancer

Status: closed to accrual

This clinical trial evaluates the Support through Remote Observation and Nutrition Guidance (STRONG) program for improving nutritional support in patients with pancreatic cancer that has spread from where it first started (primary site) to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or that can be removed by surgery (resectable). Malnutrition is a common and distressing symptom of pancreatic cancer and its treatment. Malnutrition negatively affects quality of life, treatment tolerance, and survival for pancreatic cancer patients. Despite its severity, there is limited evidence about how to manage malnutrition. The STRONG program provides enhanced dietician access and nutrition support for patients living with pancreatic cancer. The STRONG program may be more effective at providing nutritional support to pancreatic cancer patients than current practices.

Inclusion Criteria

>= 18 years old
Diagnosed metastatic or newly recurrent metastatic pancreatic cancer, locally advanced pancreatic cancer, or pre-surgical (resectable/ borderline resectable) pancreatic cancer
Receiving treatment at Moffitt or 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 secondary primary gastrointestinal (GI) cancer
Eastern Cooperative Oncology Group (ECOG) status of 2 or greater
Use of parenteral or enteral nutrition
Presence of malignant ascites

PRIMARY OBJECTIVES:

I. Assess feasibility, acceptability, and usability of a 12-week nutritional support program for metastatic, locally advanced and borderline resectable/resectable disease pancreatic cancer patients.

II. Collect pilot data on patient outcomes (malnutrition, symptom burden, quality of life) at baseline, 4-, 8-, 12- and 16-weeks. Additionally, we will collect inflammatory biomarker data at baseline and 12 weeks only.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients attend in-person and/or telehealth consultations with a dietician bi-weekly for a minimum of 6 visits, and wear and use a FitBit to log dietary intake for 12 weeks on study. Additionally, patients undergo blood sample collection on study.

GROUP II: Patients receive a referral to a dietician per usual care and wear a FitBit for 12 weeks on study. Additionally, patients undergo blood sample collection on study.

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Support through Remote Observation and Nutrition Guidance Program for Improving Nutritional Support in Patients with Locally Advanced, Metastatic and Resectable or Borderline Resectable Pancreatic Cancer

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