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OpenTrials
Completed

NCT Number: NCT04324645

Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

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.

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Key information

Conditions

Symptom Monitoring Radiation Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noona Software

Other

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.

Primary outcomes

  1. Percentage of invited symptom reports completed during the study period

    Time frame: Treatment through 90 days of follow-up (estimated to be 5 months)

  2. Percentage of questions completed within each invited symptom report

    Time frame: Treatment through 90 days of follow-up (estimated to be 5 months)

Secondary outcomes

  1. Patient reported outcomes as measured by EORTC QLQ-C30

    Time frame: Baseline, within 1 week of completing therapy and at 90-day follow-up

    It 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.

  2. Patient reported outcomes as measured by NCCN Distress Thermometer

    Time frame: Baseline, within 1 week of completing therapy and at 90-day follow-up

    Measures distress experienced during the past week. 10 = extreme distress and 0=no distress

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Varian Medical Systems

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2020
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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