Supportive Oncology Care At Home RCT

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04544046

Collaborator

Medically Home (Other)

300

Enrollment

Location

Arms

51.5

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer GastroEsophageal Cancer Rectal Cancer Head and Neck Cancer	Other: Supportive Oncology Care at Home Other: Usual Care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 16, 2020

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of participants requiring a hospital admission or emergency department visit [baseline to 6 months]
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 [baseline to 6 months]
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 [baseline to 6 months]
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 [baseline to 6 months]
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 [baseline to 6 months]
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) [baseline up to 6 months]
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) [baseline to 6 months]
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) [baseline to 6 months]
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) [baseline to 6 months]
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) [baseline to 6 months]
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) [baseline to 6 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.