Supportive Oncology Care At Home RCT

Lymphoma Clinical Trial

Official title:

Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04544046
• Other study ID #: 20-331
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• GastroEsophageal Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphoma
• Pancreatic Cancer
• Pancreatic Neoplasms
• Rectal Cancer
• Rectal Neoplasms

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