Brain TumorsNCT02489071
Cognitive Intervention After a Brain Tumor
A study testing Brain Training Program and Brain Health Program in people with Brain Tumors, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study evaluates the feasibility and utility of two behavioural programs designed to reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of participants will complete training in either program, with the remaining third a wait-list control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors
- What is being tested?
- Brain Training Program and Brain Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Aug 2018
- Phase
- Interventional
- 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
Who may be able to join
- age 18 or older
- fluent in English
- able to provide informed consent to all procedures
- diagnosis of a brain tumor
- indication of lasting post-treatment cognitive deficits (e.g., from clinical presentation, prior neuropsychological assessment, and/or self-report)
- sufficient motor and sensory functioning to complete study activities
- availability to complete all study activities
- for patients treated with cranial radiation, at least 3 months post-radiation
Who cannot join
- comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the feasibility and utility of two behavioural programs designed to reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of participants will complete training in either program, with the remaining third a wait-list control group.
Read the detailed description
Cognitive impairments (including problems with attention, memory or executive functions) are common in people with brain tumors, as a result of the disease and/or treatment effects. These deficits, even when relatively mild, can interfere with interpersonal relationships, occupational activities, functional independence, and quality of life. They may also contribute to caregiver burden.
Building on research in other cognitively-impaired populations, in this study we compare two behavioural interventions. The Brain Training (BT) and Brain Health (BH) interventions each offer a structured yet client-centered program through 8 weekly individual treatment sessions and between-session exercises. Contents include mindfulness practice, strategy training, and supportive psychoeducation including counseling around lifestyle factors to promote brain functioning.
Using a prospective randomized controlled design, 54 brain tumor patients are being enrolled in one of three study arms: BT, BH, or standard care (wait-list control). A battery of outcome measures is being administered (1) prior to intervention, (2) after the 8-week behavioural intervention (or wait-list) period, and (3) after an additional 4 months to evaluate longer-term outcomes. Analyses of variance will examine treatment effects, with regression analyses to explore moderating effects of participant demographics, severity of baseline cognitive impairment, and tumor and treatment factors (e.g., tumor location, radiation dose and distribution). Results of this trial will lay the groundwork for implementation of evidence-based supportive care to reduce and manage cognitive impairments following a brain tumor.
- Conditions
- Brain Tumors
- Being tested
- Brain Training Program, Brain Health Program
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Training ProgramBehavioural
Brain Health ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Brain Training | Experimental | 8-session cognitive training program Receives: Behavioral: Brain Training Program |
| Brain Health | Experimental | 8-session cognitive education program Receives: Behavioral: Brain Health Program |
| Control | No intervention | Wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive composite score
Summation of standardized change scores on neuropsychological tests
Measured: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Secondary outcomes (3)
Change in functional composite score
Summation of standardized change scores on measures of occupational functioning
Measured: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Change in quality of life composite score
Summation of standardized change scores on measures of affect, perceived self-efficacy, and illness burden
Measured: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Change in caregiver quality of life composite score
Summation of standardized change scores on measures of affect and caregiver burden
Measured: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Edelstein, PhD, Principal investigator, Princess Margaret Cancer Centre, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489071
- Sponsor's protocol ID
- 13-7277-CE
- Status last verified
- Sep 2018
- First submitted
- 16 Jun 2015
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Richard NM, Bernstein LJ, Mason WP, Laperriere N, Maurice C, Millar BA, Shultz DB, Berlin A, Edelstein K. Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. J Neurooncol. 2019 May;142(3):565-575. doi: 10.1007/s11060-019-03130-1. Epub 2019 Mar 7.
PubMed 30847839
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Intervention After a Brain Tumor
- ClinicalTrials.gov ID
- NCT02489071
- Acronym / sponsor ID
- 13-7277-CE
- Conditions
- Brain Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 Jul 2015 (estimated)
- 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 evaluates the feasibility and utility of two behavioural programs designed to reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of participants will complete training in either program, with the remaining third a wait-list control group.
Detailed description
Cognitive impairments (including problems with attention, memory or executive functions) are common in people with brain tumors, as a result of the disease and/or treatment effects. These deficits, even when relatively mild, can interfere with interpersonal relationships, occupational activities, functional independence, and quality of life. They may also contribute to caregiver burden.
Building on research in other cognitively-impaired populations, in this study we compare two behavioural interventions. The Brain Training (BT) and Brain Health (BH) interventions each offer a structured yet client-centered program through 8 weekly individual treatment sessions and between-session exercises. Contents include mindfulness practice, strategy training, and supportive psychoeducation including counseling around lifestyle factors to promote brain functioning.
Using a prospective randomized controlled design, 54 brain tumor patients are being enrolled in one of three study arms: BT, BH, or standard care (wait-list control). A battery of outcome measures is being administered (1) prior to intervention, (2) after the 8-week behavioural intervention (or wait-list) period, and (3) after an additional 4 months to evaluate longer-term outcomes. Analyses of variance will examine treatment effects, with regression analyses to explore moderating effects of participant demographics, severity of baseline cognitive impairment, and tumor and treatment factors (e.g., tumor location, radiation dose and distribution). Results of this trial will lay the groundwork for implementation of evidence-based supportive care to reduce and manage cognitive impairments following a brain tumor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain Training | Experimental | Behavioral: Brain Training Program8-session cognitive training program |
| Brain Health | Experimental | Behavioral: Brain Health Program8-session cognitive education program |
| Control | No intervention | –Wait-list control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 18 or older
- fluent in English
- able to provide informed consent to all procedures
- diagnosis of a brain tumor
- indication of lasting post-treatment cognitive deficits (e.g., from clinical presentation, prior neuropsychological assessment, and/or self-report)
Key exclusion criteria (1 listed)
- comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
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 |
|---|---|---|
| Brain Training Program | Behavioural | Brain Training |
| Brain Health Program | Behavioural | Brain Health |
Primary outcome
Change in cognitive composite score
Time frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Summation of standardized change scores on neuropsychological tests
3 secondary outcomes
Change in functional composite score
Time frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Change in quality of life composite score
Time frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Change in caregiver quality of life composite score
Time frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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 27 Sep 2018.
- Derived from this study: PubMed 30847839Richard NM, Bernstein LJ, Mason WP, Laperriere N, Maurice C, Millar BA, Shultz DB, Berlin A, Edelstein K. Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. J Neurooncol. 2019 May;142(3):565-575. doi: 10.1007/s11060-019-03130-1. Epub 2019 Mar 7.
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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.
Kim Edelstein, PhD principal investigator
Princess Margaret Cancer Centre, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Training Program and Brain Health Program in people with Brain Tumors, run by University Health Network, Toronto at 1 site in Canada.
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: finished, as of the sponsor's last update on 27 Sep 2018. 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 Canada. 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?
Change in cognitive composite score (time frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02489071, which also lists 1 linked publication.
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 27 Sep 2018.