Effectiveness of Cognitive Rehabilitation on Cognition and Quality of Life in Chemotherapy-Induced Cognitive Impairment: Protocol for a Randomized Control Trial

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Abstract
Background: Abnormal cell growth that can multiply and transfer to other bodily parts is referred to as cancer. Chemotherapy is a standard treatment for cancer patients. During or after treatment, patients may have varying degrees of cognitive impairment caused by the drug, which can negatively impact their quality of life. Cognitive impairment brought on by chemotherapy is one of the most frequent side effects that occur both during and after chemotherapy. Cognitive effects after and during chemotherapy have not been addressed in patients. Objective: To evaluate the effectiveness of cognitive rehabilitation on cognition and quality of life in chemotherapy-induced cognitive impairment. Methods: In this Randomized Control Trial (RCT), 60 subjects with chemotherapy-induced cognitive impairments secondary to any cancer will be randomised into 2 groups by the sequentially numbered opaque sealed envelope approach. The cognitive functions will be measured as the outcome measures, which include all the recall strategies, executive function tasks, information processing speed, and attention. Both groups will receive intervention every day for 4 weeks. Wilcoxon signed the rank test for data analysis, and students paired the “t” test, which will be used to study within-group effects. Mann-Whitney U Test and students Unpaired “t” Test will be used to compare groups at pre-treatment and post-treatment. Results: As of November 2024, we will enrol 60 participants, and the data collection process will start from November 2024- November 2025. The expected results of the effect of cognitive rehabilitation on cognition and quality of life in chemotherapy-induced cognitive impairment in cancer patients will be significant, and the expected results will be published at the end week of November 2025. Conclusions: The study design is a framework to plan and test the feasibility of the intervention. The cognitive therapy will improve the cognition in chemotherapy-induced cognitive impairment patients. Trial Registration: Clinical Trials Registry India CTRI/2024/04/065805; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTAyNTE1&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/66011

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