Brain Metastases, AdultSPiRiTNCT04567251
Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy
An observational study of Brain Metastases, Adult and Primary Brain Tumor, run by Duke University at 1 site in United States.
Trial summary
This study represents a survivorship protocol that focuses on cognition and health-related quality of life (HRQoL) in cancer patients that have received prior brain irradiation. The primary purpose of this study is to assess the feasibility of using a digital symptom tracking application focused on HRQoL and cognition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult, Primary Brain Tumor, Lung Cancer
- What is being tested?
- Noona® application
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2021to 29 May 2024
- 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: Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
Who may be able to join
- Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
- Initial radiation must have been completed more than 6 months prior to enrollment. Acceptable radiation therapies include fractionated partial brain irradiation, whole brain irradiation, or stereotactic radiosurgery (for any modality at least a total cumulative dose of 20 Gy) of at least 20 Gy
- Age ≥ 18 years at the time of entry into the study
- Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2
- No imaging evidence of disease progression within 4 months of enrollment
- Life expectancy > 6 months per treating neuro-oncology providers
- Access to a smartphone, tablet, or computer with capability to utilize the mobile symptom-tracking application
- Subject must be fluent in English
Who cannot join
- 1. Active psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy: Focus on Health-Related Quality of Life and Cognition
This study represents a survivorship protocol that focuses on cognition and health-related quality of life (HRQoL) in cancer patients that have received prior brain irradiation. The primary purpose of this study is to assess the feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation.
Read the detailed description
Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Patients will use the Noona® Healthcare Mobile PRO Application to identify real time select HRQoL and cognitive symptoms. Patients will be instructed to log symptoms as often as relevant using their own personal devices, as well as be prompted to fill out the Patient-Reported Outcomes Measurement Information System Global Health Screen (PROMIS Global Health-10 and Edmonton Symptom Assessment Scale) during treatment (weeks 9 and 14). Patient engagement with the application will be tracked to determine feasibility.
- Conditions
- Brain Metastases, Adult, Primary Brain Tumor, Lung Cancer
- Being tested
- Noona® application
- Keywords
- Pro00102684, Katherine Peters, Lung Cancer, Brain metastases, Brain tumor, Radiation, Solid tumor, Cognition, Pediatric Cancer, Cancer Survivor, Survivorship, Noona, Healthcare Mobile Application
- Medical subject headings
- Brain Neoplasms, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noona® applicationOther
A digital symptom tracking application focused on Health-Related Quality of Life (HRQOL) and cognition in cancer survivors who received brain irradiation
| Study group | Role | What they receive |
|---|---|---|
| Noona® mobile healthcare application | All patients will be instructed to report pre-defined, non-life-threatening cognitive symptoms as often as relevant through the Noona® application for 17 weeks. Receives: Other: Noona® application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation
The percentage of patients returning for their Week 15 clinic appointment who initiate PROMIS and ESAS questionnaires via the mobile application at Week 14
Measured: Baseline, 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start28 Dec 2021
- Primary completion29 May 2024
- Study completion29 May 2024
Why it stopped: PRMC closed for low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Katherine Peters, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567251
- Sponsor's protocol ID
- Pro00102684
- Acronym
- SPiRiT
- Status last verified
- May 2025
- First submitted
- 23 Sep 2020
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy: Focus on Health-Related Quality of Life and Cognition
- ClinicalTrials.gov ID
- NCT04567251
- Acronym / sponsor ID
- SPiRiT / Pro00102684
- Conditions
- Brain Metastases, Adult, Primary Brain Tumor, Lung Cancer
- Keywords
- Pro00102684, Katherine Peters, Lung Cancer, Brain metastases, Brain tumor, Radiation, Solid tumor, Cognition
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PRMC closed for low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 28 Sep 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 represents a survivorship protocol that focuses on cognition and health-related quality of life (HRQoL) in cancer patients that have received prior brain irradiation. The primary purpose of this study is to assess the feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation.
Detailed description
Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Patients will use the Noona® Healthcare Mobile PRO Application to identify real time select HRQoL and cognitive symptoms. Patients will be instructed to log symptoms as often as relevant using their own personal devices, as well as be prompted to fill out the Patient-Reported Outcomes Measurement Information System Global Health Screen (PROMIS Global Health-10 and Edmonton Symptom Assessment Scale) during treatment (weeks 9 and 14). Patient engagement with the application will be tracked to determine feasibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noona® mobile healthcare application | – | Other: Noona® applicationAll patients will be instructed to report pre-defined, non-life-threatening cognitive symptoms as often as relevant through the Noona® application for 17 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
Key inclusion criteria (8 listed)
- Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
- Initial radiation must have been completed more than 6 months prior to enrollment. Acceptable radiation therapies include fractionated partial brain irradiation, whole brain irradiation, or stereotactic radiosurgery (for any modality at least a total cumulative dose of 20 Gy) of at least 20 Gy
- Age ≥ 18 years at the time of entry into the study
- Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2
- No imaging evidence of disease progression within 4 months of enrollment
Key exclusion criteria (1 listed)
- 1. Active psychiatric illness
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® applicationA digital symptom tracking application focused on Health-Related Quality of Life (HRQOL) and cognition in cancer survivors who received brain irradiation | Other | Noona® mobile healthcare application |
Primary outcome
Feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation
Time frame: Baseline, 15 weeks
The percentage of patients returning for their Week 15 clinic appointment who initiate PROMIS and ESAS questionnaires via the mobile application at Week 14
Results and safety
The study was stopped early (reason given: PRMC closed for low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Duke Health Clinical TrialsLink provided by the sponsor.
- The Preston Robert Tisch Brain Tumor CenterLink 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.
Katherine Peters, MD, PhD principal investigator
Duke University
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 Brain Metastases, Adult and Primary Brain Tumor, run by Duke University 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 8 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: stopped early, as of the sponsor's last update on 14 May 2025. 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 was stopped early (reason given: PRMC closed for low accrual). Results are not available in the source record.
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?
Feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation (time frame: Baseline, 15 weeks). 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 14 May 2025.