None listed
Conditions
Brief summary
Study Aims This study aims to assess the impact of a telehealth-delivered cognitive and exercise training (CET) program versus lifestyle guidance 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 have received chemotherapy treatment. Study details Participants will be randomly assigned (by chance) to receive either the cognitive & exercise training (CET) program or lifestyle guidance program. Those in the CET group will be asked to undertake cognitive and exercise training four times per week (4 hours in total). The lifestyle guidance group will be provided with evidence-based recommendations regarding cognitive and exercise training. All participants will undergo a series of diagnostic and clinical tests, including blood tests, fitness and cognitive tests, sleep 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 (cognitive and exercise training versus lifestyle guidance), randomized controlled phase 1 trial. This trial will examine the feasibility, safety and therapeutic benefits of cognitive and exercise training, compared to lifestyle guidance, in stage I-III breast cancer patients treated with chemotherapy agents.
Participants will be randomly assigned (by chance) to receive telehealth-delivered cognitive and exercise training or
This is a single-blind (assessor blind to group allocation), two-arm (cognitive and exercise training versus lifestyle guidance), randomized controlled phase 1 trial. This trial will examine the feasibility, safety and therapeutic benefits of cognitive and exercise training, compared to lifestyle guidance, in stage I-III breast cancer patients treated with chemotherapy agents. Participants will be randomly assigned (by chance) to receive telehealth-delivered cognitive and exercise training or lifestyle guidance after undertaking their third assessment (after adjuvant chemotherapy). The CET intervention has been designed by an experienced team of exercise physiologists and cognitive training specialists. It comprises twelve weeks of four times weekly computerised cognitive training and aerobic exercise training (30 minutes each for cognitive and aerobic exercise training). Cognitive and exercise training components of the intervention will be counterbalanced to ensure that both therapeutic modalities are delivered equally (30 minutes of computerised cognitive training vs exercise training). Both components of the intervention will be delivered via telehealth platforms and using the Microsoft Teams application. The cognitive component of the intervention comprises computerised cognitive training exercises targeting working memory, complex attention, problem solving, planning, and cognitive flexibility and processing speed domains. Computerised cognitive training will be delivered via telehealth application and through the NeuroNation training platform. Customised algorithms developed by our group will be utilised to deliver the aforementioned cognitive training exercises. The exercise training component of the intervention comprises periodised aerobic exercise. Aerobic exercise will include walking, running, cycling and swimming activities and will be monitored using polar H10 heart rate monitors. Aerobic training sessions will be administered fortnightly by highly experienced exercise physiologists via telehealth (Microsoft Teams). Training adherence will be monitored by exercise physiologists using exercise diaries and heart rate monitors.
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 treated with chemotherapy agents and 2) 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 cognitive and exercise training.
Outcome results
None listed