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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Entails the following: 1. patient-reported symptoms, vital sign, and weight monitoring with appropriate triggers to phone calls and home visits by Medically Home based on a clinician-derived algorithm; 2. scheduled nursing visits for intravenous (IV) hydration during the course of chemotherapy; 3. regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.
Ryan Nipp
Boston, Massachusetts, United States
Rates of study enrollment
Proportion of patients who agree to participate in the study and sign informed consent.
Time frame: 2 years
Rates of completion
Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment.
Time frame: 2 years
Rates of completion of daily symptom monitoring
Proportion of participants completing daily symptom monitoring throughout the study
Time frame: 2 years
Rates of completion of daily vital signs
Proportion of participants completing daily reporting of vital signs throughout the study
Time frame: 2 years
Rates of completion of weekly body weight
Proportion of participants completing weekly reporting of body weight throughout the study
Time frame: 2 years
Number of home visits required
Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home
Time frame: 2 years
Number of phone calls required
Number of phone calls required per patient as well as average duration of these calls
Time frame: 2 years
Number of emails required
Number of emails from Medically Home to the primary oncology team
Time frame: 2 years
Patient acceptability
Qualitative acceptability ratings from patients regarding helpfulness, convenience, and perceptions of the study.
Time frame: 2 years
Family caregiver acceptability
Qualitative acceptability ratings from family caregivers regarding helpfulness, convenience, and perceptions of the study.
Time frame: 2 years
Clinician acceptability
Qualitative acceptability ratings from clinicians regarding helpfulness, convenience, and perceptions of the study.
Time frame: 2 years
Number of emergency department visits
The number of emergency department \[ED\] visits and the proportion of patients needing an emergency department \[ED\] visit
Time frame: 2 Years
Number of urgent visits
The number of urgent visits to clinic and the proportion of patients needing an urgent visit to clinic
Time frame: 2 Years
Number of hospital admissions
The number of hospital admissions and the proportion of patients needing a hospital admission
Time frame: 2 Years
Change in symptom burden longitudinally throughout the study
Change in symptom burden (assessed using Edmonton Symptom Assessment System-revised \[ESAS-r\], range 0-10 for each symptom with higher scores indicating worse symptom burden) throughout the study.
Time frame: 2 years
Change in psychological distress
Change in psychological distress (assessed using the Patient Health Questionnaire-4 \[PHQ-4\], range 0-12 with higher scores indicating greater distress, and subscales for depression/anxiety ranging 0-6 with higher scores indicating greater distress) throughout the study.
Time frame: 2 years
Change in quality of life longitudinally throughout the study
Change in quality of life (assessed using the Functional Assessment of Cancer Therapy-General \[FACT-G\], with range of 0-108 and higher scores indicating better quality of life) throughout the study.
Time frame: 2 Years
Number of cycles of FOLFIRINOX received
Describe the number of cycles of FOLFIRINOX chemotherapy received by patients
Time frame: 2 years
Number of treatment delays
Describe the number of treatment delays for patients
Time frame: 2 years
Cumulative dose of FOLFIRINOX received
Describe the cumulative dose of FOLFIRINOX received
Time frame: 2 years
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