ArticleTrials2025
Evaluation of a memory and psychomotor training for cancer patients with cancer-related cognitive impairment: a study protocol for a prospective randomized controlled single-center trial in Germany.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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9 authors.
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Abstract
backgroundCancer-related cognitive impairment (CRCI) is common and can affect the quality of life for cancer patients. Nonpharmacological interventions as cognitive training or exercise are recommended. However, research that includes both self-reported and objective outcome measures, along with longer-term follow-up to identify the most effective interventions, is lacking. This trial aims to evaluate a combined memory and psychomotor training compared to usual care with regard to objective and subjective cognitive function for cancer patients with curative treatment and CRCI.
methodsThe study is a single-center, prospective, open-label, 1:1 randomized controlled superiority trial. 170 eligible patients with (i) a curative tumor diagnosis, (ii) after chemotherapy, radiation therapy, or ongoing antibody therapy, and (iii) self-reported CRCI are recruited by study team members at a German university hospital (first planned enrollment: July 2023). Participants are randomly allocated to the intervention group (IG) or the waiting control group (CG). The IG receives a standardized interactive online group memory and psychomotor intervention (8 sessions of 60 min once a week). The CG receives usual care treatment. Participants complete assessments at baseline (t1), after the intervention (t2 IG; post-intervention) or 3 months after baseline (t2 CG), and 6 months after baseline (t3; follow-up). The primary outcome is the alertness assessed with a computer-based test (Test Battery of Attentional Performance (TAP); scale intrinsic alertness) in short- and intermediate-term (t2, t3). Secondary outcomes include objective and self-reported cognitive function, symptoms of cancer-related fatigue, quality of life, symptoms of depression, symptoms of anxiety, and physical performance. Outcomes are assessed using neuropsychological tests, validated questionnaires, and a physical function test. Training adherence and treatment satisfaction are evaluated using a self-developed questionnaire. Assessors are blind at t1; care providers are blinded. Harms are documented by study team members. Intervention effects will be evaluated separately for each follow-up time point using analysis of covariance (ANCOVA), adjusting for baseline values. Furthermore, subgroup-related treatment effects will be explored. DISCUSSION: Overall, the results will enhance our understanding of the effectiveness of the intervention in both subjective and objective cognitive outcomes in cancer patients experiencing subjective cognitive impairment. If the training shows positive effects, it should be implemented in psycho-oncological routine care.
trial registrationGerman Clinical Trials Register DRKS00027361 . Registered on 2nd December 2021.
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