Clinical Trials Logo

Clinical Trial Summary

This study evaluates the feasibility and utility of two behavioural programs designed to reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of participants will complete training in either program, with the remaining third a wait-list control group.


Clinical Trial Description

Cognitive impairments (including problems with attention, memory or executive functions) are common in people with brain tumors, as a result of the disease and/or treatment effects. These deficits, even when relatively mild, can interfere with interpersonal relationships, occupational activities, functional independence, and quality of life. They may also contribute to caregiver burden.

Building on research in other cognitively-impaired populations, in this study we compare two behavioural interventions. The Brain Training (BT) and Brain Health (BH) interventions each offer a structured yet client-centered program through 8 weekly individual treatment sessions and between-session exercises. Contents include mindfulness practice, strategy training, and supportive psychoeducation including counseling around lifestyle factors to promote brain functioning.

Using a prospective randomized controlled design, 54 brain tumor patients are being enrolled in one of three study arms: BT, BH, or standard care (wait-list control). A battery of outcome measures is being administered (1) prior to intervention, (2) after the 8-week behavioural intervention (or wait-list) period, and (3) after an additional 4 months to evaluate longer-term outcomes. Analyses of variance will examine treatment effects, with regression analyses to explore moderating effects of participant demographics, severity of baseline cognitive impairment, and tumor and treatment factors (e.g., tumor location, radiation dose and distribution). Results of this trial will lay the groundwork for implementation of evidence-based supportive care to reduce and manage cognitive impairments following a brain tumor. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02489071
Study type Interventional
Source University Health Network, Toronto
Contact
Status Completed
Phase N/A
Start date August 2014
Completion date August 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02846038 - Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
Completed NCT02537106 - A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation N/A
Completed NCT01951950 - Nicardipine vs Esmolol Craniotomy Emergence Phase 1
Completed NCT01222780 - To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer Phase 1
Completed NCT00873184 - Study of Massage Therapy Within a Brain Tumor Setting N/A
Active, not recruiting NCT01115777 - Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies
Completed NCT00724191 - Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)
Completed NCT00003935 - Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma Phase 1
Recruiting NCT04128306 - Brain Areas of Time-To-Contact Perception: an Awake Surgery Study N/A
Recruiting NCT05202899 - Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy Phase 4
Completed NCT00707343 - [F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors Phase 1
Completed NCT00850278 - Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors N/A
Terminated NCT00107471 - Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma Phase 1/Phase 2
Completed NCT00528437 - Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors Phase 2
Completed NCT00187174 - Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors Phase 1
Completed NCT00135876 - Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients Phase 3
Completed NCT00062478 - Study of Karenitecin (BNP1350) in Patients With Brain Tumors Phase 2
Completed NCT00241670 - Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid Phase 3
Not yet recruiting NCT01445691 - More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery Phase 2
Terminated NCT01018290 - Navigated Transcranial Magnetic Stimulation in Tumor Surgery N/A