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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Brain Tumor; Cerebral Metastases
• Intervention / Treatment: Behavioral: Physical Activity; Behavioral: Cognitive rehabilitation

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298-0037
      • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Physical activity intervention; 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.	Behavioral: Physical 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.; Other Names: PA
Active Comparator: Arm 2:Physical activity and cognitive intervention; 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.	Behavioral: Physical 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.; Other Names: PA; Behavioral: Cognitive 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.; Other Names: CR; Cognitive retraining
Active Comparator: Arm 3: Cognitive and begin physical activity intervention; 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.	Behavioral: Physical 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.; Other Names: PA; Behavioral: Cognitive 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.; Other Names: CR; Cognitive retraining

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment percentage of eligible subjects.	Recruitment: success defined as enrollment rate of 19% of eligible subjects.	18.5 months
Retention percentage of participants at end-of-study.	Retention: success defined as retention rate above 56% at end-of-study.	18.5 months
Non-attendance rates of participants. instructions.	Participant missed or cancelled therapy sessions less than 15% of time.	18.5 months
Lengths of sessions completed.	Participant completed full scheduled minutes per session ≥ 80% of time.	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).	18.5 months
Percentage of Cognitive Therapy intervention tasks.	Participant completed ≥ 80% of CR interventions (required < 20% rest period during or between tasks).	18.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	18.5 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Suzanne F. Taylor, PhD, MBA, OTR/L, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): July 9, 2018
• Study Completion (Actual): July 9, 2018

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; cognitive rehabilitation; whole-brain radiation therapy; sterotactic radiosurgery
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: MCC-16-13082; HM20007924 (Other Identifier: IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No