This clinical trial assesses the feasibility and patient satisfaction with an early supportive care and nutritional support program (Support Through Remote Observation and Nutrition Guidance [STRONG]) in patients with pancreatic cancer that has come back after a period of improvement (recurrent), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). The STRONG program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy. Providing early supportive care and nutritional support may improve the quality of life of patients with pancreatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05438927.
PRIMARY OBJECTIVES:
I. Assess feasibility, acceptability, and usability of a 12-week palliative care and nutritional support program for metastatic pancreatic cancer patients.
II. Collect pilot data on implementation outcomes (intervention adherence and quality).
III. Collect pilot data on patient outcomes (malnutrition, symptom burden, and quality of life) at baseline, 4-, 8-, 12- and 16-weeks.
OUTLINE:
Participants undergo an initial in-person consultation with a dietician, followed by in-person or virtual dietary consultations every other week (bi-weekly) for 12 weeks. Participants also undergo an initial in-person consultation with a supportive care clinician, followed by in-person or virtual supportive care consultations monthly for 12 weeks. Participants also wear a FitBit device and log food intake via the FitBit smartphone application (app) for 12 weeks.
After completion of study, participants are followed up at 16 weeks after study enrollment.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorAmir Alishahi Tabriz
