Cerebral Metastases, Metastatic Brain Tumor
Conditions
Keywords
whole-brain radiation therapy, sterotactic radiosurgery, cognitive rehabilitation, physical activity
Brief 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.
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.
Interventions
BEHAVIORALPhysical Activity
* 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.
BEHAVIORALCognitive rehabilitation
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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
All participants will be blinded to the study design and will be randomized into one of three treatment arms. Research assistant is blinded to both the study design and to which arm the participants are randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* A potential subject who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Cognitive Therapy intervention tasks. | 18.5 months | Participant completed ≥ 80% of CR interventions (required \< 20% rest period during or between tasks). |
| Recruitment percentage of eligible subjects. | 18.5 months | Recruitment: success defined as enrollment rate of 19% of eligible subjects. |
| Retention percentage of participants at end-of-study. | 18.5 months | Retention: success defined as retention rate above 56% at end-of-study. |
| Non-attendance rates of participants. instructions. | 18.5 months | Participant missed or cancelled therapy sessions less than 15% of time. |
| Lengths of sessions completed. | 18.5 months | Participant completed full scheduled minutes per session ≥ 80% of time. |
| Percentage of completion of Physical Activity intervention tasks. | 18.5 months | Participant completed ≥ 80% of PA interventions (required \< 20% rest period during or between tasks). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical abilities. | 18.5 months | 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. |
| Change in cognitive abilities. | 18.5 months | 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. |
Countries
United States
Outcome results
None listed