None listed
Conditions
Brief summary
Study Aims This study aims to assess the impact of a computerised cognitive training program on the neurotoxic effects of chemotherapy on cognition in breast cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 21 years or older, have been diagnosed with Stage I-III breast cancer and are scheduled to receive chemotherapy treatment. Study details Participants will be randomly assigned (by chance) to receive either the computerised cognitive training program, or continue with standard care. Those in the computerised cognitive training group will undergo 3 x 45 minute sessions for the duration of their chemotherapy (minimum of 18 weeks) The standard care group will be provided with details of the computerised cognitive training program. All participants will undertake a series of clinical assessments, including cognitive, mood, sleep, physical activity, quality of life tests and questionnaires. Potential study outcomes It is hoped this research will inform the treatment of breast cancer patients presenting with detrimental cognitive changes as a result of chemotherapy, and this research may lead to better quality of life for patients.
Interventions
This is a single-blind (assessor blind to group allocation), two-arm (computerized cognitive training versus usual care), randomized controlled phase 1 trial. This trial will examine the feasibility, safety and therapeutic benefits of computerized cognitive training, compared to usual care, in stage I-III breast cancer patients undertaking chemotherapy (minimum of 18 weeks).
Participants will be randomly assigned to computerized cognitive training and usual care groups by an independent biostat
This is a single-blind (assessor blind to group allocation), two-arm (computerized cognitive training versus usual care), randomized controlled phase 1 trial. This trial will examine the feasibility, safety and therapeutic benefits of computerized cognitive training, compared to usual care, in stage I-III breast cancer patients undertaking chemotherapy (minimum of 18 weeks). Participants will be randomly assigned to computerized cognitive training and usual care groups by an independent biostatistician. Participants will receive computerised cognitive training or usual care for the duration of chemotherapy treatment. Computerised cognitive training will be delivered from commencement through to the completion of chemotherapy (minimum of 18 weeks). The training program comprises three times weekly computerized cognitive training for 45 minutes. All training sessions will be conducted in the patients home. The computerised cognitive training program is informed by our previous work in patients with Huntington's disease. This fully-personalised program uses a series of algorithms to adapt training difficulty and content to individual cognitive profiles. Thirty-five exercises covering subdomains of memory, planning, processing speed, inhibition and attention impairments, which are compromised in breast cancer patients, will be delivered by NeuroNation software (Berlin). Adherence to the program will be monitored through the NeuroNation software and via a participant training diary. The program will be run via a secure research server in Perth. Training data will be recorded by the research server and used to analyze the association between cognitive training engagement and clinical response across individuals.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria include: 1) patients with stage I-III breast cancer prior to first line treatment, 2) patients that will receive adjuvant chemotherapy agents, and 3) patients capable of providing written and informed consent.
Exclusion criteria
Exclusion criteria include: 1) patients with brain metastases, and 2) patients with concomitant neurological, cardiovascular, and psychological conditions, and 3) patients unable to engage in computerised cognitive training,
Outcome results
None listed