Cognitive Rehabilitation for Breast Cancer Survivors with Perceived Cognitive Impairment (#332)
Background: Up to 70% of breast cancer survivors report cognitive symptoms after chemotherapy and about 30% have cognitive impairment on formal neuropsychological testing. There is no proven treatment.
Aim: To evaluate two cognitive rehabilitation programs that have shown benefits in non-cancer populations: 1) a structured neurocognitive learning program (Attention Process Training) aimed at improving cognitive deficit, and 2) Compensatory Strategy Training involving systematic teaching of strategies to help women cope with cognitive impairment.
Methods: This is a 3-arm randomised controlled trial comparing two 6 week, small group cognitive rehabilitation programs to a standard care control group in breast cancer survivors with perceived cognitive impairment 6-60 months after adjuvant chemotherapy.
Primary outcome is self-reported cognitive function measured by the FACT-COG Perceived Cognitive Impairment scale.
Secondary outcomes include objective neuropsychological performance (clinical neuropsychological tests; CogState; Functional Impact Assessment),; fatigue; anxiety and depression; and quality of life (QOL) at baseline, post intervention, 6 and 12 months post intervention.
Statistical Analysis:Linear mixed models will be used to model all continuous outcomes while accounting for covariance between repeated measures on patients, adjusting for baseline measures, maximising the precision of estimation of effects. A sample size of 159 gives 80% power to detect an effect size of 0.5 for the primary endpoint (2-sided t-test, type 1 error 0.05) between the control and either of the intervention groups. Our calculation is based upon using baseline measures as covariates (ANCOVA) assuming correlation between baseline and follow-up of 0.6.
Potential Outcomes: Cognitive impairment is recognised by breast cancer survivors as an important side-effect of treatment that impairs function and QOL. There is no proven treatment. Cognitive rehabilitation programs have the potential to treat underlying impairment or teach survivors strategies to cope with cognitive symptoms. It is important to compare both programs to determine which, if either is more beneficial than watchful waiting.