Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

Conditions
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Symptom Monitoring, Radiation Therapy

Intervention / Treatment
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* Other: Noona Software


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Symptom Monitoring via Noona<br>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 | Other: Noona Software<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |