Clinical trial NCT03798769: Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
Official title: Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Cancer
Keywords: Pancreas Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Stand Up To Cancer
First posted: 2019-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rates of study enrollment
timeFrame: 2 years
measure: Rates of completion
timeFrame: 2 years
Secondary outcomes:
measure: Rates of completion of daily symptom monitoring
timeFrame: 2 years
measure: Rates of completion of daily vital signs
timeFrame: 2 years
measure: Rates of completion of weekly body weight
timeFrame: 2 years
measure: Number of home visits required
timeFrame: 2 years
measure: Number of phone calls required
timeFrame: 2 years
measure: Number of emails required
timeFrame: 2 years
measure: Patient acceptability
timeFrame: 2 years
measure: Family caregiver acceptability
timeFrame: 2 years
measure: Clinician acceptability
timeFrame: 2 years
measure: Number of emergency department visits
timeFrame: 2 Years
measure: Number of urgent visits
timeFrame: 2 Years
measure: Number of hospital admissions
timeFrame: 2 Years
measure: Change in symptom burden longitudinally throughout the study
timeFrame: 2 years
measure: Change in psychological distress
timeFrame: 2 years
measure: Change in quality of life longitudinally throughout the study
timeFrame: 2 Years
measure: Number of cycles of FOLFIRINOX received
timeFrame: 2 years
measure: Number of treatment delays
timeFrame: 2 years
measure: Cumulative dose of FOLFIRINOX received
timeFrame: 2 years
Other outcomes:
measure: Proportion of patients requiring a hospital admission
timeFrame: 2 years
measure: Number of hospital admissions
timeFrame: 2 years
measure: Proportion of patients requiring an emergency department visit
timeFrame: 2 years
measure: Number of emergency department visits
timeFrame: 2 years
measure: Proportion of patients requiring an urgent care visit
timeFrame: 2 years
measure: Number of urgent care visits
timeFrame: 2 years
measure: Proportion of patients requiring a hospital admission or emergency department visit
timeFrame: 2 years
measure: Number of hospital admissions or emergency department visits
timeFrame: 2 years
measure: Proportion of patients requiring a treatment delay
timeFrame: 2 years
measure: Proportion of days in hospital or emergency department
timeFrame: 2 years
measure: Proportion of days in hospital, emergency department, or urgent care
timeFrame: 2 years
measure: Number of cycles of chemotherapy completed
timeFrame: 2 years
measure: Numbers of treatment delays
timeFrame: 2 years
measure: Dose intensity
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Progression free survival
timeFrame: 2 years
Locations:
city: Boston
country: United States
facility: Ryan Nipp
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan Nipp, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nipp RD, Gaufberg E, Vyas C, Azoba C, Qian CL, Jaggers J, Weekes CD, Allen JN, Roeland EJ, Parikh AR, Miller L, Wo JY, Smith MH, Brown PMC, Shulman E, Fernandez-Del Castillo C, Kimmelman AC, Ting D, Hong TS, Greer JA, Ryan DP, Temel JS, El-Jawahri A. Supportive Oncology Care at Home Intervention for Patients With Pancreatic Cancer. JCO Oncol Pract. 2022 Oct;18(10):e1587-e1593. doi: 10.1200/OP.22.00088. Epub 2022 Jul 13.