GastroEsophageal Cancer, Head and Neck Cancer, Lymphoma, Pancreatic Cancer, Rectal Cancer
Conditions
Keywords
Pancreatic Cancer, GastroEsophageal Cancer, Rectal Cancer, Head and Neck Cancer, Lymphoma
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.
Interventions
Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.
OTHERUsual Care
Standard care arm will receive standard oncology care and attend regular clinic visits.
Sponsors
Massachusetts General Hospital
Medically Home
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRyan Nipp, MD
Massachusetts General Hospital
Outcome results
None listed