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

Metastatic Brain Tumor Clinical Trial

Official title:

Does Cognitive Rehabilitation and Physical Activity Impact Executive Functioning Following Radiation Therapy for Cerebral Metastases? A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03096431
• Other study ID #: MCC-16-13082
• Secondary ID: HM20007924
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 9, 2018

Study information

• Verified date: July 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 9, 2018
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Cerebral Metastases
• Metastatic Brain Tumor
• Neoplasm Metastasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

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