Supportive Oncology Care At Home RCT
- Conditions
- GastroEsophageal CancerRectal CancerHead and Neck CancerPancreatic CancerLymphoma
- Interventions
- Other: Supportive Oncology Care at HomeOther: Usual Care
- Registration Number
- NCT04544046
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- Patients with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written or electronic informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supportive Oncology Care at Home 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 Usual Care 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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).
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).
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 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 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).
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).
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 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).
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States