Clinical trial NCT04464486: Remote COVID-19 Symptom Tracking for Cancer Patients at Home During the Pandemic
Official title: Remote COVID-19 Symptom Tracking and Improved Cancer Symptom Control for Cancer Patients at Home During the Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 301
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 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.

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.

Primary outcomes:
measure: Health Care Utilization Comparison
timeFrame: 5 months
Secondary outcomes:
measure: Patient Social Isolation
timeFrame: Monthly for 5 months
measure: COVID-19 Symptoms, Social distancing and Hygiene Practices
timeFrame: Daily for 5 months
measure: Patient Global Health
timeFrame: Monthly 5 months
measure: Patient Anxiety/Depression
timeFrame: Monthly 5 months
measure: Impact of Pandemic and Health Related Quality of Life
timeFrame: Baseline then 3 months and 5 months from baseline
measure: Cancer symptom severity
timeFrame: Daily for 5 months.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah College of Nursing
name: Kathleen Mooney, PhD
role: PRINCIPAL_INVESTIGATOR
References: