Concurrent cognitive and physical training for cognition in men with prostate cancer: a study protocol for a pilot randomized controlled trial

Alanah Pike, Joseph M. Northey, Catherine Paterson, Hollie Speer, Kristy Martin, Nicolas Cherbuin, Amit Lampit, Greg McRoberts, Ganes Pranavan, Ben Rattray

Introduction Men with prostate cancer undergoing treatment commonly report poorer cognitive performance than their age-matched controls. Within other populations, modifiable risks factors including cognitive and physical activity can independently provide potent cognitive and neuroprotective benefits. However, greater benefits may be achieved by combining stimuli simultaneously (concurrently) to promote greater neurogenesis, connectivity, and improved cognitive outcomes. This approach has been tested in older populations with and without cognitive impairment, but initial acceptability, feasibility and efficacy are yet to be demonstrated in men affected by prostate cancer. This research aims to (1) demonstrate the acceptability and feasibility of a concurrent cognitive and physical training intervention against pre-set progression criteria and, (2) provide initial estimates of intervention effectiveness on cognitive function, fatigue, and quality of life in men with prostate cancer on ADT. Methods Seventy-six men diagnosed with prostate cancer receiving androgen deprivation therapy will be the recruitment target. This pilot and feasibility study will employ a randomized controlled trial design where participants will be assigned to one of four groups: (1) concurrent training—moderate intensity stationary cycling whilst simultaneously performing computerized cognitive training, (2) moderate intensity stationary cycling only, (3) computerized cognitive training only or (4) wait-list control group. Training will be completed twice a week for 8 weeks, building up to 60 min per session. Assessment of the first aim will include an appraisal of recruitment success, adherence, adverse events, subjective acceptability, and the principle of no cognitive harm in response to the intervention. In line with aim two, additional measures will include a computerized cognitive battery and subjective questionnaires on cognition, fatigue, and quality of life. Discussion Internationally, many men continue to grapple with the debilitating effects of cognitive decline after a diagnosis and associated treatment with little, or no, evidence-based self-management strategies advised in practice. This timely research will explore the feasibility of concurrent training to treat the cognitive side-effects of androgen deprivation therapy and, in turn, inform the design of a future large-scale clinical trial. Clinical trial registration https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385591&isReview=true , identifier ACTRN12623000767606.