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

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Activity

Cognitive rehabilitation

About this trial

This is an interventional supportive care trial for Metastatic Brain Tumor focused on measuring whole-brain radiation therapy, sterotactic radiosurgery, cognitive rehabilitation, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Virginia Commonwealth University/Massey Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm 1: Physical activity intervention

Arm 2:Physical activity and cognitive intervention

Arm 3: Cognitive and begin physical activity intervention

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Recruitment percentage of eligible subjects.

Recruitment: success defined as enrollment rate of 19% of eligible subjects.

Retention percentage of participants at end-of-study.

Retention: success defined as retention rate above 56% at end-of-study.

Non-attendance rates of participants. instructions.

Participant missed or cancelled therapy sessions less than 15% of time.

Lengths of sessions completed.

Participant completed full scheduled minutes per session ≥ 80% of time.

Percentage of completion of Physical Activity intervention tasks.

Participant completed ≥ 80% of PA interventions (required < 20% rest period during or between tasks).

Percentage of Cognitive Therapy intervention tasks.

Participant completed ≥ 80% of CR interventions (required < 20% rest period during or between tasks).

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03096431

First Posted

March 23, 2017

Last Updated

July 11, 2018

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT03096431

Brief Title

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

PI leaving institution: Will not continue study.

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

July 9, 2018 (Actual)

Study Completion Date

July 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Brain Tumor, Cerebral Metastases

Keywords

whole-brain radiation therapy, sterotactic radiosurgery, cognitive rehabilitation, physical activity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

All participants will be blinded to the study design and will be randomized into one of three treatment arms. Research assistant is blinded to both the study design and to which arm the participants are randomized.

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Physical activity intervention

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Arm 2:Physical activity and cognitive intervention

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Arm 3: Cognitive and begin physical activity intervention

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Physical Activity

Other Intervention Name(s)

PA

Intervention Description

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

Intervention Name(s)

Cognitive rehabilitation

Other Intervention Name(s)

CR, Cognitive retraining

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recruitment percentage of eligible subjects.

Description

Recruitment: success defined as enrollment rate of 19% of eligible subjects.

Time Frame

18.5 months

Title

Retention percentage of participants at end-of-study.

Description

Retention: success defined as retention rate above 56% at end-of-study.

Time Frame

18.5 months

Title

Non-attendance rates of participants. instructions.

Description

Participant missed or cancelled therapy sessions less than 15% of time.

Time Frame

18.5 months

Title

Lengths of sessions completed.

Description

Participant completed full scheduled minutes per session ≥ 80% of time.

Time Frame

18.5 months

Title

Percentage of completion of Physical Activity intervention tasks.

Description

Participant completed ≥ 80% of PA interventions (required < 20% rest period during or between tasks).

Time Frame

18.5 months

Title

Percentage of Cognitive Therapy intervention tasks.

Description

Participant completed ≥ 80% of CR interventions (required < 20% rest period during or between tasks).

Time Frame

18.5 months

Secondary Outcome Measure Information:

Title

Change in cognitive abilities.

Description

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.

Time Frame

18.5 months

Title

Change in physical abilities.

Description

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.

Time Frame

18.5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University/Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0037

Country

United States

Metastatic Brain Tumor, Cerebral Metastases

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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