Supportive Oncology Care At Home RCT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Cancer, GastroEsophageal Cancer, Rectal Cancer, Head and Neck Cancer

Intervention / Treatment
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* Other: Supportive Oncology Care at Home
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, GastroEsophageal Cancer, Rectal Cancer, Head and Neck Cancer