Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

NCT04324645 | Completed

• 1 other identifier: 202003007
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptom Monitoring; Radiation Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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 Arms (1)

Active Symptom Monitoring via Noona

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

Interventions

Noona Software OTHER

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.

Active Symptom Monitoring via Noona

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a single-site study, which will be open at Siteman Cancer Center at Washington University School of Medicine.

You may qualify if:

• 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

You may not qualify if:

• Unable to reliably access and use a device compatible with Noona software.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

Study Officials

• Matthew B Spraker, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: September 3, 2020
• Primary Completion: March 13, 2022
• Study Completion: March 13, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)