Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Participant Rating on Ease of Use for the Mobile Application - Usability
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Participant Rating on Ease of Use for the Mobile Application - Usability
Time Frame: 12 Months
The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake
Data Collection - Feasibility
Time Frame: 12 Months
The study will be deemed feasible if ≥ 50% of participants submit study assessments
Recruitment Rate - Feasibility
Time Frame: 12 Months
The study will be deemed feasible if ≥ 50% of eligible participants are recruited
Secondary Outcomes
- Participant Compliance with Dietary Log - Intervention Adherence(12 Months)
- Participant Compliance with Palliative Care Visits - Intervention Adherence(12 Months)
- Participant Compliance with Dietician Visits - Intervention Adherence(12 Months)