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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
300
Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.
Standard care arm will receive standard oncology care and attend regular clinic visits.
Massachusetts General Hospital
Boston, Massachusetts, United States
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).
Time frame: baseline to 6 months
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: baseline to 6 months