Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-20 @ 4:45 PM
Study NCT ID:
NCT03798769
Status:
COMPLETED
Last Update Posted:
2022-11-22
First Post:
2018-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: