Clinical trial NCT04544046: Supportive Oncology Care At Home RCT
Official title: Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
GastroEsophageal Cancer
Rectal Cancer
Head and Neck Cancer
Lymphoma
Keywords: Pancreatic Cancer
GastroEsophageal Cancer
Rectal Cancer
Head and Neck Cancer
Lymphoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Medically Home
First posted: 2020-09-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Proportion of participants requiring a hospital admission or emergency department visit
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Proportion of days participants spend outside of the hospital during the study period
timeFrame: baseline to 6 months
measure: Proportion of patients needing an urgent visit to clinic
timeFrame: baseline to 6 months
measure: Rate of treatment delays
timeFrame: baseline to 6 months
measure: Comparison of dose intensity
timeFrame: baseline to 6 months
measure: Change in symptom burden (ESAS)
timeFrame: baseline up to 6 months
measure: Change in quality of life (FACT-G)
timeFrame: baseline to 6 months
measure: Change in psychological distress (HADS)
timeFrame: baseline to 6 months
measure: Change in care satisfaction (FAMCARE)
timeFrame: baseline to 6 months
measure: Change in Activities of Daily Living (ADLs)
timeFrame: baseline to 6 months
measure: Change in Instrumental Activities of Daily Living (IADLs)
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan Nipp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nipp RD, Shulman E, Smith M, Brown PMC, Johnson PC, Gaufberg E, Vyas C, Qian CL, Neckermann I, Hornstein SB, Reynolds MJ, Greer J, Temel JS, El-Jawahri A. Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer. BMC Cancer. 2022 Apr 9;22(1):383. doi: 10.1186/s12885-022-09461-z.