Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pancreas Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Rates of study enrollment
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The goal of this research is to study an intervention, which the investigators call "Supportive Oncology Care at Home," that entails both remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs, and body weight) and a Medically Home care model (e.g. triggers for phone calls and visits to patients' homes to address and manage any concerning issues identified). Specifically, the investigators will conduct a single arm pilot study (N=20) in patients with pancreatic cancer who sign consent for parent trial of neoadjuvant FOLFIRINOX (18-179) receiving preoperative FOLFIRINOX to assess the feasibility and acceptability of Supportive Oncology Care at Home.
Detailed Description
Preoperative treatment can cause significant morbidity and often result in hospitalizations. Patients receiving preoperative FOLFIRINOX often experience numerous side effects, including nausea, vomiting, diarrhea, fatigue, fever, neuropathy, and loss of appetite. Frequently, patients require hospital admissions to help address uncontrolled symptoms related to their cancer and side effects related to the treatment, Interventions targeting patients' symptoms and delivering care to patients at their homes have the potential to improve patient outcomes. Studies show that interventions targeting patients' symptoms can improve symptom management, enhance quality of life (QOL), and prevent hospitalizations. Medically Home interventions have shown the potential to enhance patient outcomes. The Medically Home model of care is an alternative to a hospital admission for acute care and treatment of a clinical condition. Medically Home interventions entail providing medical care to acutely ill patients in their home. In addition, research in the general medicine literature has demonstrated that interventions involving remote patient monitoring with 'triggers' for visits to patients' homes for worrisome symptoms can enhance care outcomes. Although this research demonstrates promising results, these studies have not been conducted among patients with cancer. Notably, the prior work involving home monitoring with visits as needed has lacked patient-reported outcomes, such as symptom monitoring. Thus, efforts are needed to develop and test interventions containing both symptom monitoring and the potential for home visits when necessary in a population of patients with cancer.
Investigators
Ryan Nipp
Primary Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 18 or older
- •Within three weeks of signing consent for parent trial of neoadjuvant FOLFIRINOX
- •Planning to receive care at Massachusetts General Hospital
- •Ability to read and respond to questions in English
- •Residing within 50 miles of Massachusetts General Hospital
Exclusion Criteria
- •Uncontrolled psychiatric illness or impaired cognition
Outcomes
Primary Outcomes
Rates of study enrollment
Time Frame: 2 years
Proportion of patients who agree to participate in the study and sign informed consent.
Rates of completion
Time Frame: 2 years
Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment.
Secondary Outcomes
- Rates of completion of daily vital signs(2 years)
- Number of phone calls required(2 years)
- Rates of completion of weekly body weight(2 years)
- Number of emails required(2 years)
- Number of cycles of FOLFIRINOX received(2 years)
- Rates of completion of daily symptom monitoring(2 years)
- Number of home visits required(2 years)
- Change in symptom burden longitudinally throughout the study(2 years)
- Change in quality of life longitudinally throughout the study(2 Years)
- Number of treatment delays(2 years)
- Patient acceptability(2 years)
- Family caregiver acceptability(2 years)
- Clinician acceptability(2 years)
- Number of emergency department visits(2 Years)
- Number of urgent visits(2 Years)
- Number of hospital admissions(2 Years)
- Change in psychological distress(2 years)
- Cumulative dose of FOLFIRINOX received(2 years)