Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment
Overview
- Phase
- N/A
- Intervention
- Usual Care
- Conditions
- Pancreatic Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Proportion of participants requiring a hospital admission or emergency department visit
- Status
- Active, Not Recruiting
- Last Updated
- 11 days ago
Overview
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.
Investigators
Ryan Nipp
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Usual Care
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
Intervention: Supportive Oncology Care at Home
Outcomes
Primary Outcomes
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 Outcomes
- Comparison of dose intensity(baseline to 6 months)
- Change in psychological distress (HADS)(baseline to 6 months)
- Proportion of days participants spend outside of the hospital during the study period(baseline to 6 months)
- Change in symptom burden (ESAS)(baseline up to 6 months)
- Change in care satisfaction (FAMCARE)(baseline to 6 months)
- Change in Instrumental Activities of Daily Living (IADLs)(baseline to 6 months)
- Proportion of patients needing an urgent visit to clinic(baseline to 6 months)
- Rate of treatment delays(baseline to 6 months)
- Change in quality of life (FACT-G)(baseline to 6 months)
- Change in Activities of Daily Living (ADLs)(baseline to 6 months)