Brain TumorNCT03090386
Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients
An observational study of Brain Tumor, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. Cognitive surveys will be administered after treatment of primary brain tumor cancer. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Cognitive Surveys
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2017to 15 Nov 2020
- 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 to 89 years
- All sexes
- Adult, Older adult
Study population: adults diagnosed with a malignant brain tumor either as a primary diagnosis or recurrent
Who may be able to join
- be between18 to 89 years old;
- have undergone at least one cycle of a cancer treatment regimen (e.g., chemotherapy, radiotherapy, surgery)
- have completed at least one cycle of a cancer treatment regimen within five years of enrollment in the study;
- be native speakers of American English;
- have obtained a minimum of a high school education;
- self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; and
- must demonstrate capacity to sign informed consent based on Informed Consent for Research: A Guide to Assessing a Participant's Understanding tool.
Who cannot join
- are younger than 18 years old or older than 89 years old;
- have not undergone at least one cycle of a cancer treatment regimen following diagnosis (e.g., chemotherapy, radiotherapy, surgery)
- have not undergone at least one cycle of a cancer treatment regimen in the five year period prior to enrollment;
- are not native speakers of American English;
- have not obtained a minimum of a high school education;
- do not self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; or
- do not demonstrate the capacity to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. Cognitive surveys will be administered after treatment of primary brain tumor cancer.
- Conditions
- Brain Tumor
- Being tested
- Cognitive Surveys
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive SurveysOther
Complete the Cognitive Communication Survey, standardized cognitive and language assessments, and the Follow-up Cognitive Communication Survey after treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Communication Survey
Survey is completed at time of consent
Measured: 1 day at time of consent
Secondary outcomes (2)
Cognitive-linguistic Standardized Testing
Standardized testing will be completed
Measured: within 3 months of cognitive communication survey
Follow-up Survey
Survey will be completed
Measured: within 6 months after completion of standardized testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start25 Feb 2017
- Primary completion15 Nov 2018
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia N. Laack, M.D., Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090386
- Sponsor's protocol ID
- 16-005834
- Status last verified
- Nov 2020
- First submitted
- 10 Mar 2017
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT03090386
- Acronym / sponsor ID
- 16-005834
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Feb 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 24 Mar 2017 (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 is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. Cognitive surveys will be administered after treatment of primary brain tumor cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adults diagnosed with a malignant brain tumor either as a primary diagnosis or recurrent
Key inclusion criteria (7 listed)
- be between18 to 89 years old;
- have undergone at least one cycle of a cancer treatment regimen (e.g., chemotherapy, radiotherapy, surgery)
- have completed at least one cycle of a cancer treatment regimen within five years of enrollment in the study;
- be native speakers of American English;
- have obtained a minimum of a high school education;
Key exclusion criteria (7 listed)
- are younger than 18 years old or older than 89 years old;
- have not undergone at least one cycle of a cancer treatment regimen following diagnosis (e.g., chemotherapy, radiotherapy, surgery)
- have not undergone at least one cycle of a cancer treatment regimen in the five year period prior to enrollment;
- are not native speakers of American English;
- have not obtained a minimum of a high school education;
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 |
|---|---|---|
| Cognitive SurveysComplete the Cognitive Communication Survey, standardized cognitive and language assessments, and the Follow-up Cognitive Communication Survey after treatment | Other | – |
Primary outcome
Cognitive Communication Survey
Time frame: 1 day at time of consent
Survey is completed at time of consent
2 secondary outcomes
Cognitive-linguistic Standardized Testing
Time frame: within 3 months of cognitive communication survey
Follow-up Survey
Time frame: within 6 months after completion of standardized testing
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 1 Dec 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tumor, run by Mayo Clinic 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 7 inclusion and 7 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 1 Dec 2020. 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?
Cognitive Communication Survey (time frame: 1 day at time of consent). 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 1 Dec 2020.