Metastatic Brain TumorNCT03096431
Impact of Cognitive Rehab and Physical Activity on Cognition in Patients With Metastatic Brain Tumors Undergoing RT
A study testing Physical Activity and Cognitive rehabilitation in people with Metastatic Brain Tumor and Cerebral Metastases, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
To determine the feasibility of processes and instruments with an overarching purpose to guide the design of a larger study. To determine the feasibility of individuals with metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation (CR) as in an outpatient therapy setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Brain Tumor, Cerebral Metastases
- What is being tested?
- Physical Activity and Cognitive rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 9 Jul 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
- A potential subject must meet all of the following inclusion criteria to be eligible to participate in the study:
- Ability to understand and the willingness to provide written informed consent
- 18 years of age and older
- Diagnosed with one or more metastatic brain tumor(s)
- Medical treatment plan includes whole-brain radiation therapy and / or sterotactic radiosurgery
Who cannot join
- A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- Diagnosis of dementia or unable to grant their own informed consent
- Prisoner or patient in custody
- Patient on psychiatric hold
- Physically unable to participate in the study
- The opinion of the treating physician determines it is not medically safe to participate in the study
- Pre-registration screen of cognition is "severe" or lower.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298-0037
About this study
Official title: Does Cognitive Rehabilitation and Physical Activity Impact Executive Functioning Following Radiation Therapy for Cerebral Metastases? A Pilot Study
To determine the feasibility of processes and instruments with an overarching purpose to guide the design of a larger study. To determine the feasibility of individuals with metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation (CR) as in an outpatient therapy setting.
Read the detailed description
Rolling recruitment for the study. Participants will be randomized into one of three treatment arms. All treatment arms will undergo physical \& cognitive testing prior to whole-brain radiation therapy (WBRT)/stereotactic radiosurgery (SRS). Arm 3 will receive cognitive rehabilitation intervention sessions prior to, and concurrent with, WBRT/SRS. Approximately 14 days following WBRT/SRS: all arms will undergo physical and cognitive testing, and: Arm 1 will begin physical activity intervention. Arm 2 will begin physical activity intervention and cognitive intervention. Arm 3 will continue with cognitive intervention and begin physical activity intervention. All Arms will undergo physical and cognitive testing approximately 2.5 months post WBRT/SRS.
- Conditions
- Metastatic Brain Tumor, Cerebral Metastases
- Being tested
- Physical Activity, Cognitive rehabilitation
- Keywords
- whole-brain radiation therapy, sterotactic radiosurgery, cognitive rehabilitation, physical activity
- Medical subject headings
- Brain Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Also called PA
- Self-exercise: number of steps per day, per fitness tracker; self-report of daily activity.
- One-to-one intervention: 30 minute sessions with licensed therapist to include warm-up, generalized strengthening, stretching.
Cognitive rehabilitationBehavioural
Also called CR, Cognitive retraining
One-to-one intervention: 45 minutes sessions with licensed therapist to include graded cognitive tasks designed to improve executive functioning with focus on both restorative and compensatory approaches.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Physical activity intervention | Active comparator | Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 1: intervention of physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Receives: Behavioral: Physical Activity |
| Arm 2:Physical activity and cognitive intervention | Active comparator | Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 2: intervention of both cognitive rehabilitation and physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Receives: Behavioral: Physical Activity; Behavioral: Cognitive rehabilitation |
| Arm 3: Cognitive and begin physical activity intervention | Active comparator | Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: Intervention of cognitive rehabilitation begins prior to and is concurrent with WBRT/SRS treatment. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: continue intervention of cognitive rehabilitation; add intervention of physical activity. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Receives: Behavioral: Physical Activity; Behavioral: Cognitive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment percentage of eligible subjects.
Recruitment: success defined as enrollment rate of 19% of eligible subjects.
Measured: 18.5 months
Retention percentage of participants at end-of-study.
Retention: success defined as retention rate above 56% at end-of-study.
Measured: 18.5 months
Non-attendance rates of participants. instructions.
Participant missed or cancelled therapy sessions less than 15% of time.
Measured: 18.5 months
Lengths of sessions completed.
Participant completed full scheduled minutes per session ≥ 80% of time.
Measured: 18.5 months
Percentage of completion of Physical Activity intervention tasks.
Participant completed ≥ 80% of PA interventions (required < 20% rest period during or between tasks).
Measured: 18.5 months
Percentage of Cognitive Therapy intervention tasks.
Participant completed ≥ 80% of CR interventions (required < 20% rest period during or between tasks).
Measured: 18.5 months
Secondary outcomes (2)
Change in cognitive abilities.
Composite score post-CR intervention, minus the composite score at baseline. Scores of zero indicates maintained cognition. Positive scores indicate improved cognition. Negative scores indicate declined cognition. Composite scores derived from the following four standardized tests:
- The Stroop Color Word Test (SCWT) is a 3-part measure that tests the executive function area of attention.
- The Trail Making Test (TMT) is a 2-part measure that tests the executive function area of complex attention.
- The Rey Auditory Verbal Learning Test (AVLT) is a 6-part measure that tests the executive function area of memory.
- The Clock Drawing Test (CDT) is a single measure that tests the executive function area of visuospatial relationships and praxis.
Measured: 18.5 months
Change in physical abilities.
Composite scores post intervention minus scores at baseline. Scores of zero indicate maintained physical abilities. Positive scores indicate improved physical abilities. Negative scores indicate declined physical abilities. Composite scores derived from the following two standardized tests:
- The Timed Up and Go (TUG) is a single measure that tests mobility, balance, and walking ability.
- The 30-second Chair Stand Test (30sCST) is a single measure that tests functional lower body strength.
Measured: 18.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Sep 2017
- Primary completion9 Jul 2018
- Study completion9 Jul 2018
Why it stopped: PI leaving institution: Will not continue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Brain TumorStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne F. Taylor, PhD, MBA, OTR/L, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096431
- Sponsor's protocol ID
- MCC-16-13082
- Other IDs
- HM20007924
- Status last verified
- Jul 2018
- First submitted
- 23 Mar 2017
- Last updated
- 13 Jul 2018
- 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 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cognitive Rehabilitation and Physical Activity Impact Executive Functioning Following Radiation Therapy for Cerebral Metastases? A Pilot Study
- ClinicalTrials.gov ID
- NCT03096431
- Acronym / sponsor ID
- MCC-16-13082
- Conditions
- Metastatic Brain Tumor, Cerebral Metastases
- Keywords
- whole-brain radiation therapy, sterotactic radiosurgery, cognitive rehabilitation, physical activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving institution: Will not continue study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 30 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.
To determine the feasibility of processes and instruments with an overarching purpose to guide the design of a larger study. To determine the feasibility of individuals with metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation (CR) as in an outpatient therapy setting.
Detailed description
Rolling recruitment for the study. Participants will be randomized into one of three treatment arms. All treatment arms will undergo physical \& cognitive testing prior to whole-brain radiation therapy (WBRT)/stereotactic radiosurgery (SRS). Arm 3 will receive cognitive rehabilitation intervention sessions prior to, and concurrent with, WBRT/SRS. Approximately 14 days following WBRT/SRS: all arms will undergo physical and cognitive testing, and: Arm 1 will begin physical activity intervention. Arm 2 will begin physical activity intervention and cognitive intervention. Arm 3 will continue with cognitive intervention and begin physical activity intervention. All Arms will undergo physical and cognitive testing approximately 2.5 months post WBRT/SRS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Physical activity intervention | Active comparator | Behavioral: Physical ActivityUndergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 1: intervention of physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. |
| Arm 2:Physical activity and cognitive intervention | Active comparator | Behavioral: Physical Activity, Behavioral: Cognitive rehabilitationUndergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 2: intervention of both cognitive rehabilitation and physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. |
| Arm 3: Cognitive and begin physical activity intervention | Active comparator | Behavioral: Physical Activity, Behavioral: Cognitive rehabilitationUndergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: Intervention of cognitive rehabilitation begins prior to and is concurrent with WBRT/SRS treatment. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: continue intervention of cognitive rehabilitation; add intervention of physical activity. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A potential subject must meet all of the following inclusion criteria to be eligible to participate in the study:
- Ability to understand and the willingness to provide written informed consent
- 18 years of age and older
- Diagnosed with one or more metastatic brain tumor(s)
- Medical treatment plan includes whole-brain radiation therapy and / or sterotactic radiosurgery
Key exclusion criteria (7 listed)
- A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- Diagnosis of dementia or unable to grant their own informed consent
- Prisoner or patient in custody
- Patient on psychiatric hold
- Physically unable to participate in the study
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 |
|---|---|---|
| Physical ActivityAlso: PA* Self-exercise: number of steps per day, per fitness tracker; self-report of daily activity. * One-to-one intervention: 30 minute sessions with licensed therapist to include warm-up, generalized strengthening, stretching. | Behavioural | Arm 1: Physical activity intervention, Arm 2:Physical activity and cognitive intervention, Arm 3: Cognitive and begin physical activity intervention |
| Cognitive rehabilitationAlso: CR, Cognitive retrainingOne-to-one intervention: 45 minutes sessions with licensed therapist to include graded cognitive tasks designed to improve executive functioning with focus on both restorative and compensatory approaches. | Behavioural | Arm 2:Physical activity and cognitive intervention, Arm 3: Cognitive and begin physical activity intervention |
Primary outcome
Recruitment percentage of eligible subjects.
Time frame: 18.5 months
Recruitment: success defined as enrollment rate of 19% of eligible subjects.
Retention percentage of participants at end-of-study.
Time frame: 18.5 months
Retention: success defined as retention rate above 56% at end-of-study.
Non-attendance rates of participants. instructions.
Time frame: 18.5 months
Participant missed or cancelled therapy sessions less than 15% of time.
Lengths of sessions completed.
Time frame: 18.5 months
Participant completed full scheduled minutes per session ≥ 80% of time.
Percentage of completion of Physical Activity intervention tasks.
Time frame: 18.5 months
Participant completed ≥ 80% of PA interventions (required < 20% rest period during or between tasks).
Percentage of Cognitive Therapy intervention tasks.
Time frame: 18.5 months
Participant completed ≥ 80% of CR interventions (required < 20% rest period during or between tasks).
2 secondary outcomes
Change in cognitive abilities.
Time frame: 18.5 months
Change in physical abilities.
Time frame: 18.5 months
Results and safety
The study was stopped early (reason given: PI leaving institution: Will not continue study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
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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.
Suzanne F. Taylor, PhD, MBA, OTR/L principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Cognitive rehabilitation in people with Metastatic Brain Tumor and Cerebral Metastases, run by Virginia Commonwealth 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 5 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: stopped early, as of the sponsor's last update on 13 Jul 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 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: PI leaving institution: Will not continue study.). 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?
Recruitment percentage of eligible subjects. (time frame: 18.5 months). The study lists 6 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 13 Jul 2018.