Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
- Conditions
- Pancreas Cancer
- Interventions
- Other: Supportive Oncology Care at Home
- Registration Number
- NCT03798769
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
-Uncontrolled psychiatric illness or impaired cognition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive Oncology Care at Home Supportive Oncology Care at Home The Supportive Oncology Care at Home intervention entails the following: 1. patient-reported symptoms, vital sign, and weight monitoring with appropriate triggers for 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.
- Primary Outcome Measures
Name Time Method Rates of study enrollment 2 years Proportion of patients who agree to participate in the study and sign informed consent.
Rates of completion 2 years Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment.
- Secondary Outcome Measures
Name Time Method Number of phone calls required 2 years Number of phone calls required per patient as well as average duration of these calls
Rates of completion of daily vital signs 2 years Proportion of participants completing daily reporting of vital signs throughout the study
Rates of completion of weekly body weight 2 years Proportion of participants completing weekly reporting of body weight throughout the study
Number of emails required 2 years Number of emails from Medically Home to the primary oncology team
Number of cycles of FOLFIRINOX received 2 years Describe the number of cycles of FOLFIRINOX chemotherapy received by patients
Rates of completion of daily symptom monitoring 2 years Proportion of participants completing daily symptom monitoring throughout the study
Number of home visits required 2 years Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home
Change in symptom burden longitudinally throughout the study 2 years 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.
Change in quality of life longitudinally throughout the study 2 Years 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.
Number of treatment delays 2 years Describe the number of treatment delays for patients
Patient acceptability 2 years Qualitative acceptability ratings from patients regarding helpfulness, convenience, and perceptions of the study.
Family caregiver acceptability 2 years Qualitative acceptability ratings from family caregivers regarding helpfulness, convenience, and perceptions of the study.
Clinician acceptability 2 years Qualitative acceptability ratings from clinicians regarding helpfulness, convenience, and perceptions of the study.
Number of emergency department visits 2 Years The number of emergency department \[ED\] visits and the proportion of patients needing an emergency department \[ED\] visit
Number of urgent visits 2 Years The number of urgent visits to clinic and the proportion of patients needing an urgent visit to clinic
Number of hospital admissions 2 Years The number of hospital admissions and the proportion of patients needing a hospital admission
Change in psychological distress 2 years 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.
Cumulative dose of FOLFIRINOX received 2 years Describe the cumulative dose of FOLFIRINOX received
Trial Locations
- Locations (1)
Ryan Nipp
🇺🇸Boston, Massachusetts, United States