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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798769
• Other study ID #: 18-532
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Ryan Nipp	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Stand Up To Cancer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Rates of study enrollment	Proportion of patients who agree to participate in the study and sign informed consent.	2 years
Primary	Rates of completion	Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment.	2 years
Secondary	Rates of completion of daily symptom monitoring	Proportion of participants completing daily symptom monitoring throughout the study	2 years
Secondary	Rates of completion of daily vital signs	Proportion of participants completing daily reporting of vital signs throughout the study	2 years
Secondary	Rates of completion of weekly body weight	Proportion of participants completing weekly reporting of body weight throughout the study	2 years
Secondary	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
Secondary	Number of phone calls required	Number of phone calls required per patient as well as average duration of these calls	2 years
Secondary	Number of emails required	Number of emails from Medically Home to the primary oncology team	2 years
Secondary	Patient acceptability	Qualitative acceptability ratings from patients regarding helpfulness, convenience, and perceptions of the study.	2 years
Secondary	Family caregiver acceptability	Qualitative acceptability ratings from family caregivers regarding helpfulness, convenience, and perceptions of the study.	2 years
Secondary	Clinician acceptability	Qualitative acceptability ratings from clinicians regarding helpfulness, convenience, and perceptions of the study.	2 years
Secondary	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
Secondary	Number of urgent visits	The number of urgent visits to clinic and the proportion of patients needing an urgent visit to clinic	2 Years
Secondary	Number of hospital admissions	The number of hospital admissions and the proportion of patients needing a hospital admission	2 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of cycles of FOLFIRINOX received	Describe the number of cycles of FOLFIRINOX chemotherapy received by patients	2 years
Secondary	Number of treatment delays	Describe the number of treatment delays for patients	2 years
Secondary	Cumulative dose of FOLFIRINOX received	Describe the cumulative dose of FOLFIRINOX received	2 years