Impact of Cognitive Rehab and Physical Activity on Cognition in Patients With Metastatic Brain Tumors Undergoing RT

Not Applicable

Terminated

• Conditions: Metastatic Brain Tumor; Cerebral Metastases
• Interventions: Behavioral: Physical Activity; Behavioral: Cognitive rehabilitation

• Registration Number: NCT03096431
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-30
• Study Start: 2017-09-01
• Status Verified: 2018-07
• Primary Completion: 2018-07-09
• Study Completion: 2018-07-09
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2:Physical activity and cognitive intervention	Physical Activity	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.
Arm 1: Physical activity intervention	Physical Activity	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.
Arm 3: Cognitive and begin physical activity intervention	Cognitive rehabilitation	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.
Arm 2:Physical activity and cognitive intervention	Cognitive rehabilitation	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.
Arm 3: Cognitive and begin physical activity intervention	Physical Activity	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Cognitive Therapy intervention tasks.	18.5 months	Participant completed ≥ 80% of CR interventions (required \< 20% rest period during or between tasks).
Lengths of sessions completed.	18.5 months	Participant completed full scheduled minutes per session ≥ 80% of time.
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.
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).
Non-attendance rates of participants. instructions.	18.5 months	Participant missed or cancelled therapy sessions less than 15% of time.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States