Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Completed

• Conditions: Symptom Monitoring; Radiation Therapy

• Registration Number: NCT04324645
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Study Start: 2020-09-03
• Primary Completion: 2022-03-13
• Study Completion: 2022-03-13
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of invited symptom reports completed during the study period	Treatment through 90 days of follow-up (estimated to be 5 months)
Percentage of questions completed within each invited symptom report	Treatment through 90 days of follow-up (estimated to be 5 months)

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes as measured by EORTC QLQ-C30	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.
Patient reported outcomes as measured by NCCN Distress Thermometer	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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States