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Clinical Trials/NCT04324645
NCT04324645
Completed
N/A

Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Washington University School of Medicine1 site in 1 country36 target enrollmentSeptember 3, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Symptom Monitoring
Sponsor
Washington University School of Medicine
Enrollment
36
Locations
1
Primary Endpoint
Percentage of invited symptom reports completed during the study period
Status
Completed
Last Updated
4 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
September 3, 2020
End Date
March 13, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percentage of invited symptom reports completed during the study period

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

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

  • Patient reported outcomes as measured by EORTC QLQ-C30(Baseline, within 1 week of completing therapy and at 90-day follow-up)
  • Patient reported outcomes as measured by NCCN Distress Thermometer(Baseline, within 1 week of completing therapy and at 90-day follow-up)

Study Sites (1)

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