Clinical trial NCT03096431: Impact of Cognitive Rehab and Physical Activity on Cognition in Patients With Metastatic Brain Tumors Undergoing RT
Official title: Does Cognitive Rehabilitation and Physical Activity Impact Executive Functioning Following Radiation Therapy for Cerebral Metastases? A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Brain Tumor
Cerebral Metastases
Keywords: whole-brain radiation therapy
sterotactic radiosurgery
cognitive rehabilitation
physical activity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Recruitment percentage of eligible subjects.
timeFrame: 18.5 months
measure: Retention percentage of participants at end-of-study.
timeFrame: 18.5 months
measure: Non-attendance rates of participants. instructions.
timeFrame: 18.5 months
measure: Lengths of sessions completed.
timeFrame: 18.5 months
measure: Percentage of completion of Physical Activity intervention tasks.
timeFrame: 18.5 months
measure: Percentage of Cognitive Therapy intervention tasks.
timeFrame: 18.5 months
Secondary outcomes:
measure: Change in cognitive abilities.
timeFrame: 18.5 months
measure: Change in physical abilities.
timeFrame: 18.5 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Suzanne F. Taylor, PhD, MBA, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: