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Clinical Trial 21795

Cancer Type: Gastrointestinal Tumor
Study Type: Supportive Care
NCT#: NCT05438927

Phase: N/A
Principal Investigator: Turner, Kea

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

Early Supportive Care and Nutritional Support in Adults with Pancreatic Cancer.

Summary

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.

Objective

Aim 1: Assess feasibility, acceptability, and usability of a 12-week palliative care and nutritional support program for metastatic pancreatic cancer patients. Aim 2: Collect pilot data on implementation outcomes (intervention adherence and quality). Aim 3: Collect pilot data on patient outcomes (malnutrition, symptom burden, and quality of life) at baseline, 8- and 16-weeks

Treatments

Therapies

Medications

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
  • 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 we do not anticipate that these patients would benefit from additional nutrition intervention.

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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