Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

The Washington University

Status: Completed

Conditions: Radiation Therapy; Symptom Monitoring

Treatments: Other: Noona Software

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04324645

202003007

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

36 participants in 1 patient group

Active Symptom Monitoring via Noona

Description:

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

Treatment:

Other: Noona Software