Supportive Oncology Care At Home RCT

Mass General Brigham

Status: Active, not recruiting

Conditions: Lymphoma; Head and Neck Cancer; GastroEsophageal Cancer; Rectal Cancer; Pancreatic Cancer

Treatments: Other: Usual Care; Other: Supportive Oncology Care at Home

Study type: Interventional

Funder types: Other

Identifiers

NCT04544046

20-331

Details and patient eligibility

About

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 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care

Supportive Oncology Care at Home

Experimental group

Description:

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

Treatment:

Other: Supportive Oncology Care at Home