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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.
BMC Psychology ( IF 2.588 ) Pub Date : 2015-11-28 , DOI: 10.1186/s40359-015-0100-5
Marie-Rose Dwek 1 , Lorna Rixon 1 , Alice Simon 1 , Catherine Hurt 1 , Stanton Newman 1
Affiliation  

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. AIM 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. DESIGN 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. DISCUSSION 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.

中文翻译:

检查辅助化疗对大肠癌患者认知的影响以及任何认知障碍对生活质量的影响:研究方案。

背景研究表明,化学疗法可导致患者客观测量和自我报告的认知能力均不足,进而影响其生活质量(QoL)。大多数研究使用了治疗后的回顾性设计,或者未在预期队列中包括对照组。这限制了可以从结果中得出的结论。也有不成比例的针对女性乳腺癌的研究,这限制了研究结果对其他癌症人群的推广。目的本研究旨在确定大肠癌患者化疗引起的认知功能下降的程度和影响。QoL较差的可能关联也将被探索。设计这将是一项纵向对照队列研究。在化疗前,化疗中和化疗后,从五个伦敦NHS信托基金会的78名结直肠癌患者的连续样本中,收集测量主观认知功能,QoL,疲劳和情绪以及客观认知功能的神经心理学评估的问卷。将在相同的时间点对另外78名仅接受结直肠癌手术的患者进行评估;这将使研究人员能够将接受手术但未接受化疗的患者与接受两种治疗的患者进行比较。通过客观的神经心理学评估和自我报告的问卷调查,将计算出化疗前后的差异评分,以检测认知功能的细微变化。将在每次神经心理学测试中为每位患者计算出标准化的z得分,以及每个时间点的每个测试。然后将化学治疗前的分数减去化学治疗后的分数,以产生每个患者的相对差异分数。在控制性别,年龄,抑郁,焦虑,疲劳和受教育程度的影响时,ANCOVA将用于比较化疗组和仅手术组之间的平均差异z得分。讨论本研究的结果将表明认知功能下降是否可归因于化学疗法或疾病,手术或其他混杂因素。识别认知缺陷的危险因素可用于指导有针对性的干预措施,以改善生活质量并帮助患者应对。然后将化学治疗前的分数减去化学治疗后的分数,以产生每个患者的相对差异分数。在控制性别,年龄,抑郁,焦虑,疲劳和受教育程度的影响时,ANCOVA将用于比较化疗组和仅手术组之间的平均差异z得分。讨论本研究的结果将表明认知功能下降是否可归因于化学疗法或疾病,手术或其他混杂因素。识别认知缺陷的危险因素可用于指导有针对性的干预措施,以改善生活质量并帮助患者应对。然后将化学治疗前的分数减去化学治疗后的分数,以产生每个患者的相对差异分数。在控制性别,年龄,抑郁,焦虑,疲劳和受教育程度的影响时,ANCOVA将用于比较化疗组和仅手术组之间的平均差异z得分。讨论本研究的结果将表明认知功能下降是否可归因于化学疗法或疾病,手术或其他混杂因素。识别认知缺陷的危险因素可用于指导有针对性的干预措施,以改善生活质量并帮助患者应对。抑郁,焦虑,疲劳和教育。讨论本研究的结果将表明认知功能下降是否可归因于化学疗法或疾病,手术或其他混杂因素。识别认知缺陷的危险因素可用于指导有针对性的干预措施,以改善生活质量并帮助患者应对。抑郁,焦虑,疲劳和教育。讨论本研究的结果将表明认知功能下降是否可归因于化学疗法或疾病,手术或其他混杂因素。识别认知缺陷的危险因素可用于指导有针对性的干预措施,以改善生活质量并帮助患者应对。
更新日期:2019-11-01
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