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OncologyNCT04464486

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

A study testing SCH Intervention in people with Oncology, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oncology
What is being tested?
SCH Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
1 siteUnited States
Study dates
21 Apr 2020to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Remote COVID-19 Symptom Tracking and Improved Cancer Symptom Control for Cancer Patients at Home During the Pandemic

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.

Read the 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
Being tested
SCH Intervention
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCH InterventionOther

    Also called Symptom Care at Home 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.

Study groups in NCT04464486
Study groupRoleWhat they receive
COVID-19 Symptom Augmented SCH InterventionExperimentalThe 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.
Receives: Other: SCH Intervention
Enhanced Usual CareNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health Care Utilization Comparison

    Retrospective chart review of health care utilization of both groups

    Measured: 5 months

Secondary outcomes (6)

  1. Patient Social Isolation

    Patient Reported Outcomes Measurement Information System- Short Form v2.0 Social Isolation- 6a. The PROMIS Social Isolation item bank assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. The item bank does not use a time frame (e.g. over the past seven days) when assessing social isolation. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Social Isolation, a T-score of 60 is one SD worse than average. By comparison, a Social Isolation Tscore of 40 is one SD better than average.

    Measured: Monthly for 5 months

  2. COVID-19 Symptoms, Social distancing and Hygiene Practices

    Patient reported outcomes collected in automated SCH system daily of COVID-19 symptoms, social distancing and hygiene practices, and COVID-19 related cancer treatment impacts and daily living impacts on cancer patients receiving the SCH -COVID intervention. The investigators will describe patterns of cancer patients and their adherence to social distancing and hygiene practices over time.

    Measured: Daily for 5 months

  3. Patient Global Health

    Patient Reported Outcomes Measurement Information System Scale v1.2- Global Health Survey Short Form 10. High scores reflect better functioning. To find the total raw score for these scales with all questions answered, sum the values of the response to each question for a given respondent.

    Measured: Monthly 5 months

  4. Patient Anxiety/Depression

    Hospital Anxiety and Depression Scale (HADS) measurement of psychological distress in non-psychiatric patients.

    Measured: Monthly 5 months

  5. Impact of Pandemic and Health Related Quality of Life

    COVID-19: Impact of the Pandemic and Health Related Quality Of Life (HRQOL) in Cancer Patients and Survivors

    Measured: Baseline then 3 months and 5 months from baseline

  6. Cancer symptom severity

    Patient reported outcomes collected in automated SCH system daily of cancer symptom severity on a scale of 0-10 with 0 being no pain and 10 being worst pain imaginable. Description of symptom severity over time will be reported

    Measured: Daily for 5 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start21 Apr 2020
  3. Primary completion30 Aug 2021
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464486
Sponsor's protocol ID
IRB_00131892
Status last verified
Nov 2023
First submitted
26 Jun 2020
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Secondary data analysis and use by other investigators is welcomed once the proposed aims have been analyzed and published. PI Mooney will share de-identified data with other investigators for study by proposing aims/hypotheses and identifying the data elements required and receiving agreement from the research team. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA). The research team agrees to share data in a manner that is fully consistent with the data sharing policies of NIH and the University of Utah as well as applicable laws and regulations.

Questions about this trial

What is this clinical trial studying?

A study testing SCH Intervention in people with Oncology, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Care Utilization Comparison (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04464486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.

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