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Pancreas CancerNCT03798769

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

A study testing Supportive Oncology Care at Home in people with Pancreas Cancer, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
Supportive Oncology Care at Home
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
31 Jan 2019to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • -Uncontrolled psychiatric illness or impaired cognition

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ryan Nipp

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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.

Conditions
Pancreas Cancer
Being tested
Supportive Oncology Care at Home
Keywords
Pancreas Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supportive Oncology Care at HomeOther

    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.
Study groups in NCT03798769
Study groupRoleWhat they receive
Supportive Oncology Care at HomeExperimentalThe 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.
Receives: Other: Supportive Oncology Care at Home

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates of study enrollment

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

    Measured: 2 years

  2. Rates of completion

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

    Measured: 2 years

Secondary outcomes (18)

  1. Rates of completion of daily symptom monitoring

    Proportion of participants completing daily symptom monitoring throughout the study

    Measured: 2 years

  2. Rates of completion of daily vital signs

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

    Measured: 2 years

  3. Rates of completion of weekly body weight

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

    Measured: 2 years

  4. 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

    Measured: 2 years

  5. Number of phone calls required

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

    Measured: 2 years

  6. Number of emails required

    Number of emails from Medically Home to the primary oncology team

    Measured: 2 years

  7. Patient acceptability

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

    Measured: 2 years

  8. Family caregiver acceptability

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

    Measured: 2 years

  9. Clinician acceptability

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

    Measured: 2 years

  10. Number of emergency department visits

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

    Measured: 2 Years

  11. Number of urgent visits

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

    Measured: 2 Years

  12. Number of hospital admissions

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

    Measured: 2 Years

  13. 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.

    Measured: 2 years

  14. 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.

    Measured: 2 years

  15. 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.

    Measured: 2 Years

  16. Number of cycles of FOLFIRINOX received

    Describe the number of cycles of FOLFIRINOX chemotherapy received by patients

    Measured: 2 years

  17. Number of treatment delays

    Describe the number of treatment delays for patients

    Measured: 2 years

  18. Cumulative dose of FOLFIRINOX received

    Describe the cumulative dose of FOLFIRINOX received

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2019
  2. Study start31 Jan 2019
  3. Primary completion1 Jun 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03798769
Sponsor's protocol ID
18-532
Status last verified
Nov 2022
First submitted
27 Dec 2018
Last updated
22 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 35830625

Questions about this trial

What is this clinical trial studying?

A study testing Supportive Oncology Care at Home in people with Pancreas Cancer, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of study enrollment (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03798769, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.

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