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Completed

NCT Number: NCT03798769

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.

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Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ryan Nipp

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supportive Oncology Care at Home

Other

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.

Primary outcomes

  1. Rates of study enrollment

    Time frame: 2 years

    Proportion of patients who agree to participate in the study and sign informed consent.

  2. Rates of completion

    Time frame: 2 years

    Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment.

Secondary outcomes

  1. Rates of completion of daily symptom monitoring

    Time frame: 2 years

    Proportion of participants completing daily symptom monitoring throughout the study

  2. Rates of completion of daily vital signs

    Time frame: 2 years

    Proportion of participants completing daily reporting of vital signs throughout the study

  3. Rates of completion of weekly body weight

    Time frame: 2 years

    Proportion of participants completing weekly reporting of body weight throughout the study

  4. Number of home visits required

    Time frame: 2 years

    Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home

  5. Number of phone calls required

    Time frame: 2 years

    Number of phone calls required per patient as well as average duration of these calls

  6. Number of emails required

    Time frame: 2 years

    Number of emails from Medically Home to the primary oncology team

  7. Patient acceptability

    Time frame: 2 years

    Qualitative acceptability ratings from patients regarding helpfulness, convenience, and perceptions of the study.

  8. Family caregiver acceptability

    Time frame: 2 years

    Qualitative acceptability ratings from family caregivers regarding helpfulness, convenience, and perceptions of the study.

  9. Clinician acceptability

    Time frame: 2 years

    Qualitative acceptability ratings from clinicians regarding helpfulness, convenience, and perceptions of the study.

  10. Number of emergency department visits

    Time frame: 2 Years

    The number of emergency department [ED] visits and the proportion of patients needing an emergency department [ED] visit

  11. Number of urgent visits

    Time frame: 2 Years

    The number of urgent visits to clinic and the proportion of patients needing an urgent visit to clinic

  12. Number of hospital admissions

    Time frame: 2 Years

    The number of hospital admissions and the proportion of patients needing a hospital admission

  13. Change in symptom burden longitudinally throughout the study

    Time frame: 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.

  14. Change in psychological distress

    Time frame: 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.

  15. Change in quality of life longitudinally throughout the study

    Time frame: 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.

  16. Number of cycles of FOLFIRINOX received

    Time frame: 2 years

    Describe the number of cycles of FOLFIRINOX chemotherapy received by patients

  17. Number of treatment delays

    Time frame: 2 years

    Describe the number of treatment delays for patients

  18. Cumulative dose of FOLFIRINOX received

    Time frame: 2 years

    Describe the cumulative dose of FOLFIRINOX received

Other outcomes

  1. Proportion of patients requiring a hospital admission

    Time frame: 2 years

    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. Number of hospital admissions

    Time frame: 2 years

    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

  3. Proportion of patients requiring an emergency department visit

    Time frame: 2 years

    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

  4. Number of emergency department visits

    Time frame: 2 years

    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

  5. Proportion of patients requiring an urgent care visit

    Time frame: 2 years

    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

  6. Number of urgent care visits

    Time frame: 2 years

    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

  7. Proportion of patients requiring a hospital admission or emergency department visit

    Time frame: 2 years

    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

  8. Number of hospital admissions or emergency department visits

    Time frame: 2 years

    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

  9. Proportion of patients requiring a treatment delay

    Time frame: 2 years

    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

  10. Proportion of days in hospital or emergency department

    Time frame: 2 years

    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

  11. Proportion of days in hospital, emergency department, or urgent care

    Time frame: 2 years

    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

  12. Number of cycles of chemotherapy completed

    Time frame: 2 years

    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

  13. Numbers of treatment delays

    Time frame: 2 years

    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

  14. Dose intensity

    Time frame: 2 years

    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

  15. Overall survival

    Time frame: 2 years

    Compare difference in overall survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home

  16. Progression free survival

    Time frame: 2 years

    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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Stand Up To Cancer

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2019
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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