Supportive Oncology Care At Home RCT

Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma; Head and Neck Cancer; Pancreatic Cancer; Rectal Cancer; GastroEsophageal Cancer
• Intervention / Treatment: Other: Usual Care; Other: Supportive Oncology Care at Home

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan Nipp, MD; Phone Number: (617) 724-4000; Email: rnipp@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, head and neck cancer, or lymphoma
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; 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.	Other: Usual Care; Standard care arm will receive standard oncology care and attend regular clinic visits.
Experimental: Supportive Oncology Care at Home; 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	Other: Supportive Oncology Care at Home; Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	baseline to 6 months
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).	baseline to 6 months
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).	baseline to 6 months
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).	baseline to 6 months
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).	baseline up to 6 months
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).	baseline to 6 months
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).	baseline to 6 months
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).	baseline to 6 months
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).	baseline to 6 months
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).	baseline to 6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Medically Home
• Investigators: Principal Investigator: Ryan Nipp, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Lymphoma; Pancreatic Cancer; Rectal Cancer; GastroEsophageal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Pancreatic Diseases; Head and Neck Neoplasms; Rectal Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: 20-331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No