Does Cognitive Rehabilitation and Physical Activity Impact Executive Functioning Following Radiation Therapy for Cerebral Metastases? A Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Metastatic Brain Tumor
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Percentage of Cognitive Therapy intervention tasks.
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Percentage of Cognitive Therapy intervention tasks.
Time Frame: 18.5 months
Participant completed ≥ 80% of CR interventions (required \< 20% rest period during or between tasks).
Lengths of sessions completed.
Time Frame: 18.5 months
Participant completed full scheduled minutes per session ≥ 80% of time.
Recruitment percentage of eligible subjects.
Time Frame: 18.5 months
Recruitment: success defined as enrollment rate of 19% of eligible subjects.
Retention percentage of participants at end-of-study.
Time Frame: 18.5 months
Retention: success defined as retention rate above 56% at end-of-study.
Percentage of completion of Physical Activity intervention tasks.
Time Frame: 18.5 months
Participant completed ≥ 80% of PA interventions (required \< 20% rest period during or between tasks).
Non-attendance rates of participants. instructions.
Time Frame: 18.5 months
Participant missed or cancelled therapy sessions less than 15% of time.
Secondary Outcomes
- Change in cognitive abilities.(18.5 months)
- Change in physical abilities.(18.5 months)