Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

NCT ID: NCT04324645

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-03

Study Completion Date

2022-03-13

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.

Detailed Description

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Conditions

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Symptom Monitoring Radiation Therapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Noona Software

Intervention Type 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.

Interventions

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Noona Software

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varian Medical Systems

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew B Spraker, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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202003007

Identifier Type: -

Identifier Source: org_study_id

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