Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Radiation Therapy Clinical Trial

Official title:

Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324645
• Other study ID #: 202003007
• Status: Completed
• Start date: September 3, 2020
• Est. completion date: March 13, 2022

Study information

• Verified date: April 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 13, 2022
• Est. primary completion date: March 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Radiation Therapy
• Symptom Monitoring

Intervention

Other:
• Noona 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of invited symptom reports completed during the study period		Treatment through 90 days of follow-up (estimated to be 5 months)
Primary	Percentage of questions completed within each invited symptom report		Treatment through 90 days of follow-up (estimated to be 5 months)
Secondary	Patient reported outcomes as measured by EORTC QLQ-C30	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.	Baseline, within 1 week of completing therapy and at 90-day follow-up
Secondary	Patient reported outcomes as measured by NCCN Distress Thermometer	Measures distress experienced during the past week. 10 = extreme distress and 0=no distress	Baseline, within 1 week of completing therapy and at 90-day follow-up

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine