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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04544046
Other study ID # 20-331
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 16, 2020
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.
Usual Care
Standard care arm will receive standard oncology care and attend regular clinic visits.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Medically Home

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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