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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001548729
Enrollment
10
Registered
2022-12-14
Start date
2023-12-14
Completion date
2025-01-10
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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 stimulatin

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.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

From baseline, study inclusion criteria require participants to be aged over 18 years old, currently live in Perth and Peel regions of Western Australia (or close enough), have been diagnosed with non-CNS cancer, be currently undergoing any treatment, and have a working proficiency of the English language. Participants invited to take part in the RCT will have cancer, access to and ability to use a phone/tablet/computer with internet for six weeks, and will demonstrate cognitive impairment, operationalised by scores meeting one or more of the following criteria (Vardy et al., 2007; Wefel et al., 2011): scores = 1.0SD below the norm on two or more objective cognitive measures; or score of = 1.5SD below the norm on one or more objective cognitive measures; Global Deficit Score (GDS) = 0.5 points. GDS = mean of deficit scores (which are converted from T scores). A GDS of 0.5 or greater indicates the mean of the objective cognitive measure scores is = 1SD below the norm. Note that “norm” means demographic matched normative scores from neuropsychological compendium. If necessitated, subjective impairment will also be considered; evidence thereof will be identified through FACT-Cog Perceived Cognitive Impairment (18-item) subscale scores < 54 (Dyk et al., 2020).

Exclusion criteria

From baseline, exclusion criteria preclude participation of individuals with premorbid developmental / cognitive dysfunction; premorbid neurodegenerative conditions; pregnancy; and central nervous system metastases. Inverse of the baseline inclusion criteria, participants not demonstrating cognitive impairment are not invited to the RCT.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026