ABSTRACT Objective Cancer‐related cognitive impairment (CRCI) is a frequent side effect of cancer and its treatment that can persist well after treatment completion, with major impacts on quality of life, daily living activities, and return to work. This randomised pilot study assesses the feasibility and acceptability of methods and procedures intended for use in a definitive trial of a web‐based cognitive rehabilitation program—‘Responding to Cognitive Concerns” (eReCog)—in people with low perceived cognitive function after chemotherapy for aggressive lymphoma within the past 5 years and were in remission. Potential efficacy was also explored. Methods Participants were randomised one‐to‐one to receive usual care or eReCog plus usual care. The 4‐week eReCog program consists of four online modules based on the principles of cognitive behavioral therapy. Operational, neuropsychological test and patient‐reported outcome measures (PROMs) data were collected before randomisation and approximately 8 weeks later to assess trial outcomes. Primary feasibility outcomes included recruitment and retention rates (a priori progression criteria: ≥ 3 patients/month and ≥ 80% of participants complete the trial, respectively). Feasibility data were summarised using a rate or proportion, as appropriate, with 95% confidence intervals. Neuropsychological test and PROMs data were analyzed using analysis of covariance. Results 38 of 53 eligible participants consented to participate over 10 months (3.8 patients/month, 95% CI 2.7, 5.2), 19 were randomised to each arm, and 36 of 38 (95%, 95% CI 83, 99) completed the trial, indicating acceptable feasibility. Acceptable feasibility was also found for all four secondary outcomes: adherence to, usability of, and intrinsic motivation to engage with eReCog; and compliance with assessments. A large‐sized difference favoring the intervention arm was observed on the SCWT Word score measuring processing speed. Medium‐sized differences were observed on other neuropsychological test and PROM scales, but confidence intervals were wide and included zero. Conclusions Recruitment and retention rates, compliance with assessments and favorable changes on potential outcome measures suggest a large‐scale, appropriately powered trial is warranted, as do findings that eReCog is acceptable to the study population. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN 12623000705684
Gates et al. (Wed,) studied this question.