Supportive Oncology Care At Home RCT

Overview

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.

Full Title of Study: “Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2024

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

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

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of participants requiring a hospital admission or emergency department visit
    • Time Frame: 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 Measures

  • Proportion of days participants spend outside of the hospital during the study period
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • Medically Home
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ryan Nipp, Principal Investigator – Massachusetts General Hospital
  • Overall Official(s)
    • Ryan Nipp, MD, Principal Investigator, Massachusetts General Hospital

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