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

NCT03096431 | Terminated

• 2 other identifiers: MCC-16-13082HM20007924
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Brain Tumor; Cerebral Metastases

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Recruitment percentage of eligible subjects.

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

  18.5 months

• Retention percentage of participants at end-of-study.

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

  18.5 months

• Non-attendance rates of participants. instructions.

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

  18.5 months

• Lengths of sessions completed.

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

  18.5 months

• 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

• Percentage of Cognitive Therapy intervention tasks.

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

  18.5 months

Secondary Outcomes (2)

• Change in cognitive abilities.

  18.5 months

• Change in physical abilities.

  18.5 months

Study Arms (3)

Arm 1: Physical activity intervention

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity

Arm 2:Physical activity and cognitive intervention

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity; Behavioral: Cognitive rehabilitation

Arm 3: Cognitive and begin physical activity intervention

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity; Behavioral: Cognitive rehabilitation

Interventions

Physical Activity 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.

Also known as: PA

Arm 1: Physical activity intervention; Arm 2:Physical activity and cognitive intervention; Arm 3: Cognitive and begin physical activity intervention

Cognitive rehabilitation 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.

Also known as: CR, Cognitive retraining

Arm 2:Physical activity and cognitive intervention; Arm 3: Cognitive and begin physical activity intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to provide written informed consent
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Motor Activity

Interventions

Exercise; Cognitive Training

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Suzanne F. Taylor, PhD, MBA, OTR/L

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 30, 2017
• Study Start: September 1, 2017
• Primary Completion: July 9, 2018
• Study Completion: July 9, 2018
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

US (1)