Remote COVID-19 Symptom Tracking for Cancer Patients at Home During the Pandemic

NCT ID: NCT04464486

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-21
• Study Completion Date: 2022-09-30

Brief Summary

This project will evaluate the benefit of an automated home symptom monitoring system, Symptom Care at Home, to track COVID-19 symptoms, provide instructions to reduce COVID-19 exposure, and reduce cancer symptom severity during the COVID-19 pandemic. The investigators will determine if Symptom Care at Home decreases the need for cancer patients to use emergency departments and hospitalization for cancer symptom care. The project addresses the urgent public health need for cancer patients to reduce their risk for COVID-19 exposure.

Detailed Description

In response to the COVID-19 pandemic, there is an opportunity to rapidly flex platforms for remote cancer symptom tracking and management to incorporate COVID-19 symptom monitoring and reinforce risk-reducing precautions. It is critical for cancer patients at home to monitor early indications of COVID-19 symptoms, to adhere to mitigation strategies, as well as to manage their cancer-related symptoms so that patients can decrease the need to utilize the emergency department or unplanned hospitalizations for symptom care, which is a common occurrence during cancer care. Remote monitoring adds a layer of home-based support which can benefit all cancer patients and is not restricted to geographic proximity to oncology providers or distance from a cancer center. The Symptom Care at Home (SCH) system, utilized for the Principal Investigator's currently funded R01CA206522 project to monitor and manage patient-reported (PRO) cancer symptoms, includes these necessary elements: remote PRO symptom monitoring, patient self-management information, and oncology provider (nurse practitioner) notification of symptoms exceeding pre-set thresholds. The overall purpose of this project is to describe the impacts of COVID-19 on cancer patients' well-being at home and evaluate, through a randomized clinical trial, if a systematic patient-reported outcomes (PRO) reporting process improves cancer care during a pandemic as compared to usual care. Specific Aims include: 1) describe patient-reported COVID-19 and cancer symptom trajectories over time, COVID-19 social distancing and hygiene practices, and COVID-19 related cancer treatment and daily living impacts on cancer patients receiving the SCH-COVID intervention and 2) compare the SCH-COVID intervention to enhanced usual care on health care utilization, COVID-19 diagnosis and outcomes, cancer treatment delays or changes, and patient-reported global health, anxiety, mood, and feelings of social isolation.

Conditions

Oncology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

COVID-19 Symptom Augmented SCH Intervention

The SCH intervention group will report COVID-19 and cancer-related symptom presence and severity daily into the automated SCH system. Participants receive automated self-management support messages for symptoms reported and a Nurse Practitioner monitors and responds to alerts for COVID-19 symptoms and poorly controlled or worsening cancer symptoms. Participants in this group complete baseline and monthly measures.

Group Type: EXPERIMENTAL

SCH Intervention

Intervention Type: OTHER

In addition to receiving usual care from their oncologist and staff, the SCH intervention group will report COVID-19 and cancer-related symptom presence and severity daily into the automated SCH system. Participants in the intervention receive automated self-management support messages for symptoms reported. In addition, COVID-19 symptoms and poorly controlled or worsening cancer symptoms will generate alerts. Based on preset thresholds, alerts automatically generate immediately from the patient's daily call data. The study nurse practitioners (NPs) monitor alerts. The NPs provide follow-up care using the guideline based SCH symptom clinical decision support system. The NPs log into the SCH Alert and Call Data website which displays all of the patients who have called that day and met an alert threshold. The NP calls the patient, delivers symptom management care by phone, and documents care in the patients' electronic health records.

Enhanced Usual Care

Participants in the control group are given information by research staff reviewing COVID-19 symptoms, home precautions, and instructions on what to do to address concerns that arise. Participants in this group complete baseline and monthly measures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SCH Intervention

In addition to receiving usual care from their oncologist and staff, the SCH intervention group will report COVID-19 and cancer-related symptom presence and severity daily into the automated SCH system. Participants in the intervention receive automated self-management support messages for symptoms reported. In addition, COVID-19 symptoms and poorly controlled or worsening cancer symptoms will generate alerts. Based on preset thresholds, alerts automatically generate immediately from the patient's daily call data. The study nurse practitioners (NPs) monitor alerts. The NPs provide follow-up care using the guideline based SCH symptom clinical decision support system. The NPs log into the SCH Alert and Call Data website which displays all of the patients who have called that day and met an alert threshold. The NP calls the patient, delivers symptom management care by phone, and documents care in the patients' electronic health records.

Intervention Type: OTHER

Other Intervention Names

Symptom Care at Home Intervention

Eligibility Criteria

Inclusion Criteria

• Participants will be patients who are receiving treatment for a cancer diagnosis at Huntsman Cancer Hospital.
• Must be able to speak, read, and understand English language.
• Must have a smartphone and be willing and able to download the SCH application and enter data into the application OR must be willing to make phone calls to report symptoms using the telephone interactive voice response (IVR) system.

Exclusion Criteria

• Patients enrolled in another study protocol that prohibits participation in other trials.
• Patients under the age of 18.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Mooney

Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Mooney, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah College of Nursing

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRB_00131892

Identifier Type: -

Identifier Source: org_study_id