RecruitingACTRN12622001548729

Cognitive decline in cancer: Investigating a brain training intervention

Cancer-related cognitive impairment: Investigating the impact of a brain training intervention on cognition, psychosocial factors, and neurogenesis biomarkers


Sponsor

Curtin University

Enrollment

100 participants

Start Date

Dec 14, 2023

Study Type

Interventional

Conditions

Summary

This study is investigating cancer-related cognitive impairment, and the impact of a cognitive training intervention. Who is it for? You may be eligible for this study if you are aged 18 years or over, living in or near the Perth/Peel regions of Western Australia, are currently undergoing any treatment for a confirmed diagnosis of cancer, AND are experiencing possible associated cognitive decline. Completion of baseline of this study will determine said eligibility. Study details The intervention of the study requires participants to complete brain training sessions involving puzzles, games, and word problems for 12 hours across 6 weeks. Follow-up tests (1 week and 3 month) investigating memory, attention, executive function, and processing speed will be performed, as well as other psychological factors such as quality of life, sleep, anxiety, and pain. Biological markers implicated in neurogenesis will also be assessed through blood tests, direct questions, and with reference to medical history. It is hoped that findings from this study will assist researchers with optimising daily oncology care.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Cancer treatment can affect thinking, memory, and concentration in ways that significantly impact daily life — a cluster of symptoms often referred to as "chemo brain." This study is investigating whether a structured cognitive training program (brain training) can help people with cancer who are experiencing these difficulties. It is the second part of a two-part study: participants are first screened for cognitive impairment (in the related cross-sectional study), and those who show measurable impairment are invited to join this intervention trial. The brain training intervention involves completing puzzles, word games, and memory exercises for a total of 12 hours over six weeks, using a phone, tablet, or computer. Cognitive tests, questionnaires, and blood samples will be collected before the training, one week after it finishes, and again three months later to track whether the training leads to lasting improvements in memory, attention, and quality of life. You may be eligible if you are 18 or older, have a non-brain cancer and are currently receiving treatment in the Perth/Peel region of Western Australia, have internet access and a smart device, and have been found to have objective cognitive impairment on assessments completed in the cross-sectional phase of the study. You would not be eligible if you have a pre-existing cognitive or developmental condition, a neurodegenerative disease, are pregnant, or have cancer that has spread to the brain.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Brief name: cognitive training Variables collected include cognitive performance, psychosocial functioning, medical history, and peripheral plasma brain-derived neurotrophic factor (BDNF) levels.

Brief name: cognitive training Variables collected include cognitive performance, psychosocial functioning, medical history, and peripheral plasma brain-derived neurotrophic factor (BDNF) levels. This study entails a double blinded randomised control trial, evaluating the efficacy of a cognitive training intervention in treating cancer-related cognitive impairment (CRCI). The doctoral candidate is blinded to the intervention/control groups. Cognitive training is theorised to work by stimulating neuroplasticity - a process intricately linked with neurogenesis. The intervention used in the RCT will be a computerised cognitive training intervention (Cognifit) which will be administered at home, through participants' personal hardware (computer, phone, tablet). The procedure for participants entails completing brain training tasks. The task difficulty will be tailored by the programme software to each individual participant, in order to be sufficiently challenging but not overwhelming. This is to facilitate yield of optimal cognitive benefit. The tailoring of the difficulty is done automatically by the programme throughout each training session. The control group participants will be receiving a placebo/active control, which are cognitive activities that do not target proposed impaired domains of cognition (i.e., memory, attention, executive function, and processing speed). The process, administration, delivery, location etc. will mirror the intervention group. Cognitive training tasks include (but are not limited to): puzzles, games, word problems. The cognitive training will be a global battery of tasks, with stimulated domains including (but not limited to) memory, attention, executive function, and processing speed. This intervention is self-administered with reminders. The doctoral candidate leading the study will provide information on use to participants. Each participant will follow their own timeline. The intervention will be delivered across six weeks, with a minimum of four administrations per week; each session will be a minimum of 20 minutes. To clarify, the base requirement is that participants must complete a minimum of 120 minutes of training per week - i.e., 720 minutes / 12 hours of training across the six weeks. The additional requirements are that the weekly 120 minutes must be completed across four or more training sessions, and each session should be a minimum of 20 minutes. However, note that four sessions of 20 minutes do not actually meet the minimum weekly 120 minutes - they merely form the minimum training parameters. The actual duration of each session will depend on total weekly number of sessions. This can be done multiple ways. Some possible examples include (but are not limited to): o 4 x 30 min = 120 min o 6 x 20 min = 120 min o 3 x 20 min + 2 x 30 min = 120 min o 2 x 20 min + 2 x 25 min + 1 x 30 min = 120 min There is no maximum amount of training. Each participant will be asked to complete the training in their own home at whichever times best suit them, so long as the minimum 12 hours of training is achieved, in the required weekly increments. Additionally, a CogniFit General Cognitive Assessment (30 min) will be completed at the start and end of the six weeks; this is an in house tool is required for the programme to calibrate and evaluate the participants' training. Intervention adherence and fidelity will be assessed by the doctoral candidate. The daily reminders will help minimise attrition. At the end of this six-week trial, participants will attend a follow-up assessment (90-120 min), mirroring the appointment at the baseline. Ideally, this follow-up will be conducted within one week of completing cognitive training.


Locations(1)

WA, Australia

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