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

NCT04464486 | Completed DMC

• 1 other identifier: IRB_00131892
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

• Health Care Utilization Comparison

  Retrospective chart review of health care utilization of both groups

  5 months

Secondary Outcomes (6)

• Patient Social Isolation

  Monthly for 5 months

• COVID-19 Symptoms, Social distancing and Hygiene Practices

  Daily for 5 months

• Patient Global Health

  Monthly 5 months

• Patient Anxiety/Depression

  Monthly 5 months

• Impact of Pandemic and Health Related Quality of Life

  Baseline then 3 months and 5 months from baseline

Study Arms (2)

COVID-19 Symptom Augmented SCH Intervention

EXPERIMENTAL

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.

Other: SCH Intervention

Enhanced Usual Care

NO INTERVENTION

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.

Interventions

SCH Intervention 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.

Also known as: Symptom Care at Home Intervention

COVID-19 Symptom Augmented SCH Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kathleen Mooney, PhD

  University of Utah College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 9, 2020
• Study Start: April 21, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After acceptance of the main findings publications in peer reviewed scientific journals.
• Access Criteria: Data will be available to address research questions/hypothesis of the request. Once the Principal Investigator reviews the research question proposed, the data elements that can address the question will be shared.

Locations

US (1)