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Supportive Oncology Care At Home RCT

Primary Purpose

Pancreatic Cancer, GastroEsophageal Cancer, Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supportive Oncology Care at Home
Usual Care
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, GastroEsophageal Cancer, Rectal Cancer, Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • To be eligible, patients must be: age 18 or older
  • Receiving definitive treatment (i.e. neoadjuvant chemotherapy and/or chemoradiation with curative intent) for pancreatic, gastroesophageal, rectal, or head and neck cancer
  • Within two weeks of starting treatment
  • Planning to receive care at Massachusetts General Hospital (MGH)
  • Verbally fluent in English
  • Residing within 50 miles of Massachusetts General Hospital

Exclusion Criteria:

  • Patients with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written or electronic informed consent.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Supportive Oncology Care at Home

Arm Description

Participants assigned to the standard care arm will receive standard oncology care and attend regular clinic visits. Participants on the standard care arm will complete questionnaires from baseline up to 6 months following enrollment.

The research study procedures include: Remote monitoring of symptoms, vitals, and body weight Questionnaires asking about demographic information (e.g. gender, ethnicity, income) and experience with cancer (e.g. quality of life, symptoms) Data collection from medical record

Outcomes

Primary Outcome Measures

Proportion of participants requiring a hospital admission or emergency department visit
Compare the difference between study arms using Fisher's exact tests, and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender).

Secondary Outcome Measures

Proportion of days participants spend outside of the hospital during the study period
Linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Proportion of patients needing an urgent visit to clinic
Linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Rate of treatment delays
Compare rates of treatment interruptions (e.g. delays) using Fisher's exact tests and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender).
Comparison of dose intensity
Compare dose intensity using linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Change in symptom burden (ESAS)
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Change in quality of life (FACT-G)
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Change in psychological distress (HADS)
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Change in care satisfaction (FAMCARE)
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Change in Activities of Daily Living (ADLs)
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Change in Instrumental Activities of Daily Living (IADLs)
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).

Full Information

First Posted
September 3, 2020
Last Updated
November 18, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Medically Home
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1. Study Identification

Unique Protocol Identification Number
NCT04544046
Brief Title
Supportive Oncology Care At Home RCT
Official Title
Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Medically Home

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study is evaluating a program that entails remote monitoring and home-based care for people with cancer who are receiving chemotherapy, radiotherapy, or chemoradiotherapy.
Detailed Description
Participants receiving treatment for cancer often require multiple care visits and may experience significant symptoms and side-effects related to the cancer and the cancer treatment. This research study is evaluating if a program that involves remote monitoring and home-based care may improve the quality of life, ability to manage symptoms, and overall care of individuals during cancer treatment. Remote monitoring is broadly defined as a way of monitor outside of conventional clinical settings (e.g. in the home) that often utilizes technology to increase access to care. Eligible participants will be randomized into one of two groups: Usual Care or Supportive Oncology Care at Home It is expected that about 300 people will take part in this research study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, GastroEsophageal Cancer, Rectal Cancer, Head and Neck Cancer
Keywords
Pancreatic Cancer, GastroEsophageal Cancer, Rectal Cancer, Head and Neck Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants assigned to the standard care arm will receive standard oncology care and attend regular clinic visits. Participants on the standard care arm will complete questionnaires from baseline up to 6 months following enrollment.
Arm Title
Supportive Oncology Care at Home
Arm Type
Experimental
Arm Description
The research study procedures include: Remote monitoring of symptoms, vitals, and body weight Questionnaires asking about demographic information (e.g. gender, ethnicity, income) and experience with cancer (e.g. quality of life, symptoms) Data collection from medical record
Intervention Type
Other
Intervention Name(s)
Supportive Oncology Care at Home
Intervention Description
Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Standard care arm will receive standard oncology care and attend regular clinic visits.
Primary Outcome Measure Information:
Title
Proportion of participants requiring a hospital admission or emergency department visit
Description
Compare the difference between study arms using Fisher's exact tests, and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender).
Time Frame
baseline to 6 months
Secondary Outcome Measure Information:
Title
Proportion of days participants spend outside of the hospital during the study period
Description
Linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline to 6 months
Title
Proportion of patients needing an urgent visit to clinic
Description
Linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline to 6 months
Title
Rate of treatment delays
Description
Compare rates of treatment interruptions (e.g. delays) using Fisher's exact tests and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender).
Time Frame
baseline to 6 months
Title
Comparison of dose intensity
Description
Compare dose intensity using linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline to 6 months
Title
Change in symptom burden (ESAS)
Description
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline up to 6 months
Title
Change in quality of life (FACT-G)
Description
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline to 6 months
Title
Change in psychological distress (HADS)
Description
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline to 6 months
Title
Change in care satisfaction (FAMCARE)
Description
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline to 6 months
Title
Change in Activities of Daily Living (ADLs)
Description
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline to 6 months
Title
Change in Instrumental Activities of Daily Living (IADLs)
Description
Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).
Time Frame
baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible, patients must be: age 18 or older Receiving definitive treatment (i.e. neoadjuvant chemotherapy and/or chemoradiation with curative intent) for pancreatic, gastroesophageal, rectal, or head and neck cancer Within two weeks of starting treatment Planning to receive care at Massachusetts General Hospital (MGH) Verbally fluent in English Residing within 50 miles of Massachusetts General Hospital Exclusion Criteria: Patients with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written or electronic informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Nipp, MD
Phone
(617) 724-4000
Email
rnipp@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Nipp, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Nipp, MD
Phone
617-724-4000
Email
rnipp@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ryan Nipp, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
Citations:
PubMed Identifier
35397575
Citation
Nipp RD, Shulman E, Smith M, Brown PMC, Johnson PC, Gaufberg E, Vyas C, Qian CL, Neckermann I, Hornstein SB, Reynolds MJ, Greer J, Temel JS, El-Jawahri A. Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer. BMC Cancer. 2022 Apr 9;22(1):383. doi: 10.1186/s12885-022-09461-z.
Results Reference
derived

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Supportive Oncology Care At Home RCT

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