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

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ClinicalTrials.gov Identifier: NCT03798769
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Stand Up To Cancer
Information provided by (Responsible Party):
Ryan Nipp, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Other: Supportive Oncology Care at Home Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Oncology Care at Home

The Supportive Oncology Care at Home intervention entails the following:

  1. 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
  2. scheduled nursing visits for intravenous (IV) hydration during the course of chemotherapy;
  3. regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.
Other: Supportive Oncology Care at Home

Entails the following:

  1. 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;
  2. scheduled nursing visits for intravenous (IV) hydration during the course of chemotherapy;
  3. regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798769


Contacts
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Contact: Ryan Nipp, MD, MPH 6177244000 rnipp@mgh.harvard.edu

Locations
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United States, Massachusetts
Ryan Nipp Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ryan Nipp, MD, MPH    617-724-4000    rnipp@mgh.harvard.edu   
Principal Investigator: Ryan Nipp, MD, MPH         
Sponsors and Collaborators
Massachusetts General Hospital
Stand Up To Cancer
Investigators
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Principal Investigator: Ryan Nipp, MD, MPH Massachusetts General Hospital

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Responsible Party: Ryan Nipp, Primary Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03798769     History of Changes
Other Study ID Numbers: 18-532
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication.
Access Criteria: Requests may be directed to: [contact information for Sponsor-Investigator or designee].

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Nipp, Massachusetts General Hospital:
Pancreas Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases