Symptom MonitoringNCT04324645
Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies
An observational study of Symptom Monitoring and Radiation Therapy, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptom Monitoring, Radiation Therapy
- What is being tested?
- Noona Software
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 13 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a single-site study, which will be open at Siteman Cancer Center at Washington University School of Medicine.
Who may be able to join
- 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
Who cannot join
- -Unable to reliably access and use a device compatible with Noona software.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Noona Software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noona SoftwareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Noona Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of invited symptom reports completed during the study period
Measured: Treatment through 90 days of follow-up (estimated to be 5 months)
Percentage of questions completed within each invited symptom report
Measured: Treatment through 90 days of follow-up (estimated to be 5 months)
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline, within 1 week of completing therapy and at 90-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start3 Sep 2020
- Primary completion13 Mar 2022
- Study completion13 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom MonitoringStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Matthew B Spraker, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324645
- Sponsor's protocol ID
- 202003007
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies
- ClinicalTrials.gov ID
- NCT04324645
- Acronym / sponsor ID
- 202003007
- Conditions
- Symptom Monitoring, Radiation Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 13 Mar 2022 (actual)
- Study completion
- 13 Mar 2022 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Symptom Monitoring via Noona | – | Other: Noona SoftwareParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-site study, which will be open at Siteman Cancer Center at Washington University School of Medicine.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Unable to reliably access and use a device compatible with Noona software.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noona SoftwareEnrolled 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. | Other | Active Symptom Monitoring via Noona |
Primary outcome
Percentage of invited symptom reports completed during the study period
Time frame: Treatment through 90 days of follow-up (estimated to be 5 months)
Percentage of questions completed within each invited symptom report
Time frame: Treatment through 90 days of follow-up (estimated to be 5 months)
2 secondary outcomes
Patient reported outcomes as measured by EORTC QLQ-C30
Time frame: Baseline, within 1 week of completing therapy and at 90-day follow-up
Patient reported outcomes as measured by NCCN Distress Thermometer
Time frame: Baseline, within 1 week of completing therapy and at 90-day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew B Spraker, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptom Monitoring and Radiation Therapy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of invited symptom reports completed during the study period (time frame: Treatment through 90 days of follow-up (estimated to be 5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.