Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Completed

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Active Symptom Monitoring via Noona	Noona Software	Participants will undergo a single training session on how to use the Noona software no more than 4-12 weeks before starting therapy. They can start using the software immediately after the training session. Patients will be invited to complete either the Chest Radiotherapy (if radiotherapy alone), Chemotherapy-18 (if chemoradiation therapy), or Bone Radiotherapy (if other) module at baseline, every other week throughout therapy, and during follow up for 90-days. Patients will be encouraged by the treatment team to complete the baseline symptom report prior to starting any therapy and to complete the reports during therapy and in follow up. Patients will also complete the EORTC QLQ-C30 and the NCCN Distress Thermometer at baseline (no more than 12 weeks before starting therapy), within 1 week of completing therapy, and at 90-days follow up. Patients will be encouraged to use Noona's other features beyond invited modules and PRO inventories, such as the diary during the study

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

Locations (1): Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States

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