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

NCT03798769 | Completed

• 1 other identifier: 18-532
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer

Keywords

Pancreas Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Rates of completion of daily symptom monitoring

  2 years

• Rates of completion of daily vital signs

  2 years

• Rates of completion of weekly body weight

  2 years

• Number of home visits required

  2 years

• Number of phone calls required

  2 years

Other Outcomes (16)

• Proportion of patients requiring a hospital admission

  2 years

• Number of hospital admissions

  2 years

• Proportion of patients requiring an emergency department visit

  2 years

Study Arms (1)

Supportive Oncology Care at Home

EXPERIMENTAL

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

Interventions

Supportive Oncology Care at Home OTHER

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.

Supportive Oncology Care at Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled psychiatric illness or impaired cognition

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Stand Up To Cancer: collaborator

Study Sites (1)

Ryan Nipp

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 35830625 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ryan Nipp, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 10, 2019
• Study Start: January 31, 2019
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Requests may be directed to: \[contact information for Sponsor-Investigator or designee\].

Locations

US (1)