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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
2
* 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.
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.
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Recruitment percentage of eligible subjects.
Recruitment: success defined as enrollment rate of 19% of eligible subjects.
Time frame: 18.5 months
Retention percentage of participants at end-of-study.
Retention: success defined as retention rate above 56% at end-of-study.
Time frame: 18.5 months
Non-attendance rates of participants. instructions.
Participant missed or cancelled therapy sessions less than 15% of time.
Time frame: 18.5 months
Lengths of sessions completed.
Participant completed full scheduled minutes per session ≥ 80% of time.
Time frame: 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).
Time frame: 18.5 months
Percentage of Cognitive Therapy intervention tasks.
Participant completed ≥ 80% of CR interventions (required \< 20% rest period during or between tasks).
Time frame: 18.5 months
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.
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Time frame: 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.
Time frame: 18.5 months