Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX

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.

Study Overview

• Status: Completed
• Conditions: Pancreas Cancer
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ryan Nipp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive Oncology Care at Home; The Supportive Oncology Care at Home intervention entails the following: 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; scheduled nursing visits for intravenous (IV) hydration during the course of chemotherapy;; regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.

Other: Supportive Oncology Care at Home; Entails the following: 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;; scheduled nursing visits for intravenous (IV) hydration during the course of chemotherapy;; regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of study enrollment	Proportion of patients who agree to participate in the study and sign informed consent.	2 years
Rates of completion	Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of completion of daily symptom monitoring	Proportion of participants completing daily symptom monitoring throughout the study	2 years
Rates of completion of daily vital signs	Proportion of participants completing daily reporting of vital signs throughout the study	2 years
Rates of completion of weekly body weight	Proportion of participants completing weekly reporting of body weight throughout the study	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	2 years
Number of phone calls required	Number of phone calls required per patient as well as average duration of these calls	2 years
Number of emails required	Number of emails from Medically Home to the primary oncology team	2 years
Patient acceptability	Qualitative acceptability ratings from patients regarding helpfulness, convenience, and perceptions of the study.	2 years
Family caregiver acceptability	Qualitative acceptability ratings from family caregivers regarding helpfulness, convenience, and perceptions of the study.	2 years
Clinician acceptability	Qualitative acceptability ratings from clinicians regarding helpfulness, convenience, and perceptions of the study.	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	2 Years
Number of urgent visits	The number of urgent visits to clinic and the proportion of patients needing an urgent visit to clinic	2 Years
Number of hospital admissions	The number of hospital admissions and the proportion of patients needing a hospital admission	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.	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.	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.	2 Years
Number of cycles of FOLFIRINOX received	Describe the number of cycles of FOLFIRINOX chemotherapy received by patients	2 years
Number of treatment delays	Describe the number of treatment delays for patients	2 years
Cumulative dose of FOLFIRINOX received	Describe the cumulative dose of FOLFIRINOX received	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients requiring a hospital admission	Compare difference in proportion of patients with hospital admissions between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Number of hospital admissions	Compare difference in number of hospital admissions between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Proportion of patients requiring an emergency department visit	Compare difference in proportion of patients with emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Number of emergency department visits	Compare difference in number of emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Proportion of patients requiring an urgent care visit	Compare difference in proportion of patients with urgent care visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Number of urgent care visits	Compare difference in number of urgent care visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Proportion of patients requiring a hospital admission or emergency department visit	Compare difference in proportion of patients with a hospital admission or emergency department visit between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Number of hospital admissions or emergency department visits	Compare difference in number of hospital admissions or emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Proportion of patients requiring a treatment delay	Compare difference in proportion of patients with a treatment delay between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Proportion of days in hospital or emergency department	Compare difference in proportion of days in hospital or emergency department between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Proportion of days in hospital, emergency department, or urgent care	Compare difference in proportion of days in hospital, emergency department, or urgent care between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Number of cycles of chemotherapy completed	Compare difference in number of cycles of chemotherapy completed between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Numbers of treatment delays	Compare difference in number of treatment delays between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Dose intensity	Compare difference in chemotherapy dose intensity between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Overall survival	Compare difference in overall survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years
Progression free survival	Compare difference in progression free survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Stand Up To Cancer
• Investigators: Principal Investigator: Ryan Nipp, MD, MPH, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pancreas Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 18-532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor-Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Requests may be directed to: [contact information for Sponsor-Investigator or designee].
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No