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Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04324645
Enrollment
36
Registered
2020-03-27
Start date
2020-09-03
Completion date
2022-03-13
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Therapy, Symptom Monitoring

Brief summary

This study seeks to achieve two aims: * To assess the implementation of Noona software for continuous symptom monitoring for a diverse population of patients with thoracic malignancies who are undergoing radiation and * To validate remote collection of standardized PRO measures using Noona software.

Interventions

OTHERNoona Software

Enrolled patients will be provided with login information for their Noona account. Patients will log in to the Noona symptom monitoring system using their own computer hardware. Any type of personal computer or compatible mobile device will be allowed (i.e. iPhone, Android phone). Patients will be able to access the Noona system from any internet access point and will be provided with the hospital/clinic public WiFi information.

Sponsors

Varian Medical Systems
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Biopsy confirmed cancer. Radiographically apparent (i.e. not histologically or cytologically confirmed) malignancy of the thorax is allowed. * Currently planning to receive radiotherapy with or without chemotherapy for greater than one fraction. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). * Age 18 years or older

Exclusion criteria

-Unable to reliably access and use a device compatible with Noona software.

Design outcomes

Primary

MeasureTime frame
Percentage of invited symptom reports completed during the study periodTreatment through 90 days of follow-up (estimated to be 5 months)
Percentage of questions completed within each invited symptom reportTreatment through 90 days of follow-up (estimated to be 5 months)

Secondary

MeasureTime frameDescription
Patient reported outcomes as measured by EORTC QLQ-C30Baseline, within 1 week of completing therapy and at 90-day follow-upIt includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Patients respond on a four-point scale from not at all to very much for most items. Most items use a past week recall period. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.
Patient reported outcomes as measured by NCCN Distress ThermometerBaseline, within 1 week of completing therapy and at 90-day follow-upMeasures distress experienced during the past week. 10 = extreme distress and 0=no distress

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026