title: Examining the effects of adjuvant chemotherapy on cognition and the impact of any cognitive impairment on quality of life in colorectal cancer patients: study protocol.
abstract: BACKGROUND
  Research suggests that chemotherapy can cause deficits in both patients' objectively measured and self-reported cognitive abilities which can in turn affect their quality of life (QoL). The majority of research studies have used post-treatment retrospective designs or have not included a control group in prospective cohorts. This has limited the conclusions that can be drawn from the results. There have also been a disproportionate number of studies focussed on women with breast cancer, which has limited the generalisability of the results to other cancer populations.
  
  
  OBJECTIVE
  This study aims to identify the extent and impact of chemotherapy-induced cognitive decline in colorectal cancer patients. Possible associations with poorer QoL will also be explored.
  
  
  METHODS
  This will be a longitudinal controlled cohort study. Questionnaires measuring subjective cognitive functioning, QoL, fatigue and mood, and neuropsychological assessments of objective cognitive function will be collected pre-, mid- and post- chemotherapy treatment from a consecutive sample of 78 colorectal cancer patients from five London NHS Trusts. A further 78 colorectal cancer surgery only patients will be assessed at equivalent time points; this will allow the researchers to compare the results of patients undergoing surgery, but not chemotherapy against those receiving both treatments. Pre- and post-chemotherapy difference scores will be calculated to detect subtle changes in cognitive function as measured by the objective neuropsychological assessments and the self-reported questionnaires. A standardised z-score will be computed for every patient on each neuropsychological test, and for each test at each time point. The post-chemotherapy score will then be subtracted from the pre-chemotherapy score to produce a relative difference score for each patient. ANCOVA will be used to compare mean difference z-scores between the chemotherapy and surgery-only groups while controlling for the effects of gender, age, depression, anxiety, fatigue and education.
  
  
  CONCLUSIONS
  The result from this study will indicate whether a decline in cognitive functioning can be attributed to chemotherapy or to disease, surgical or some other confounding factor. Identification of risk factors for cognitive deficits may be used to inform targeted interventions, in order to improve QoL and help patients' cope.
authors.affiliation: School of Health Sciences, City University London, 10 Northampton Square, London, EC1V 0HB, UK. Marie-Rose.Dwek.2@city.ac.uk.
authors.forename: Marie-Rose
authors.initials: MR
authors.lastname: Dwek
authors.affiliation: School of Health Sciences, City University London, 10 Northampton Square, London, EC1V 0HB, UK. Lorna.Rixon.1@city.ac.uk.
authors.forename: Lorna
authors.initials: L
authors.lastname: Rixon
authors.affiliation: School of Health Sciences, City University London, 10 Northampton Square, London, EC1V 0HB, UK. Alice.Simon.1@city.ac.uk.
authors.forename: Alice
authors.initials: A
authors.lastname: Simon
authors.affiliation: School of Health Sciences, City University London, 10 Northampton Square, London, EC1V 0HB, UK. Catherine.Hurt.1@city.ac.uk.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hurt
authors.affiliation: School of Health Sciences, City University London, 10 Northampton Square, London, EC1V 0HB, UK. Stanton.Newman.1@city.ac.uk.
authors.forename: Stanton
authors.initials: S
authors.lastname: Newman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects*; D003071:Cognition / Q000187:drug effects; D003072:Cognition Disorders / Q000139:chemically induced*; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008131:London; D008137:Longitudinal Studies; D008875:Middle Aged; D009483:Neuropsychological Tests; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires