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

NCT ID: NCT03096431

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-07-09

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.

Conditions

Metastatic Brain Tumor; Cerebral Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physical Activity

Intervention Type: BEHAVIORAL

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Physical Activity

Intervention Type: BEHAVIORAL

• 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 rehabilitation

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Physical Activity

Intervention Type: BEHAVIORAL

• 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 rehabilitation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PA; CR; Cognitive retraining

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne F. Taylor, PhD, MBA, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20007924

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-16-13082

Identifier Type: -

Identifier Source: org_study_id