Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

Abstract Background We estimated clinically important, group-level differences in self-reported cognitive function for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) instrument. We also investigated individual level change that could be considered meaningful for cancer sur...

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Main Authors: M L Bell, H M Dhillon, V J Bray, J L Vardy
Format: Article
Language:English
Published: SpringerOpen 2018-10-01
Series:Journal of Patient-Reported Outcomes
Subjects:
Online Access:http://link.springer.com/article/10.1186/s41687-018-0071-4
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author M L Bell
H M Dhillon
V J Bray
J L Vardy
author_facet M L Bell
H M Dhillon
V J Bray
J L Vardy
author_sort M L Bell
collection DOAJ
description Abstract Background We estimated clinically important, group-level differences in self-reported cognitive function for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) instrument. We also investigated individual level change that could be considered meaningful for cancer survivors affected by cognitive impairment following chemotherapy, and that could be used for responder analyses. We used data from a multi-site randomized controlled trial in 242 participants that evaluated a web-based intervention for improving self-reported cognitive functioning in adult cancer survivors who reported cognitive impairment and who had adjuvant chemotherapy in the previous 6–60 months. We used anchor and distribution methods to estimate a range of clinically important differences (CIDs) and investigated meaningful change thresholds (MCTs) for the FACT-Cog and the Perceived Cognitive Impairments (PCI) subscale, post-intervention and at six-month follow-up with empirical cumulative distribution functions. Our primary anchor was the patient reported cognitive function subscale of the European Organization for Research and Treatment of Cancer Quality of Life-Cognitive Functioning Scale (EORTC-CF). Results Most participants were female (95%) breast cancer survivors (89%). Correlation of changes in the FACT-Cog and the EORTC-CF were 0.55 post-intervention and 0.61 at follow-up. Anchor-based CID estimates for the FACT-Cog using our primary anchor were 11.3 points (post) and 8.8 (follow-up), which corresponds to a standardized effect size of 0.49 and 0.38; 8.6% and 6.6% of the total scale’s range. Anchor-based CID estimates for the FACT-Cog PCI subscale were 7.4 (post) and 4.6 points (follow-up), which corresponds to a standardized effect size of 0.50 and 0.31; 10.3% and 6.4% of the PCI range). Empirical cumulative distribution functions of change in FACT-Cog demonstrating possible MCTs showed that anchor change of none, minimally better and much better were well separated. Conclusions The CID and MCT estimates from this manuscript can help in the design, analysis and interpretation of self-reported cognitive function in cancer patients and survivors.
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spelling doaj.art-d6114ed03eb64122aba4d50825aac6492022-12-21T19:44:13ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202018-10-012111110.1186/s41687-018-0071-4Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)M L Bell0H M Dhillon1V J Bray2J L Vardy3Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of ArizonaCentre for Medical Psychology & Evidence-based Decision-making, School of Psychology, University of SydneyDepartment of Medical Oncology, Liverpool Hospital and University of SydneyConcord Cancer Centre and Sydney Medical School, University of SydneyAbstract Background We estimated clinically important, group-level differences in self-reported cognitive function for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) instrument. We also investigated individual level change that could be considered meaningful for cancer survivors affected by cognitive impairment following chemotherapy, and that could be used for responder analyses. We used data from a multi-site randomized controlled trial in 242 participants that evaluated a web-based intervention for improving self-reported cognitive functioning in adult cancer survivors who reported cognitive impairment and who had adjuvant chemotherapy in the previous 6–60 months. We used anchor and distribution methods to estimate a range of clinically important differences (CIDs) and investigated meaningful change thresholds (MCTs) for the FACT-Cog and the Perceived Cognitive Impairments (PCI) subscale, post-intervention and at six-month follow-up with empirical cumulative distribution functions. Our primary anchor was the patient reported cognitive function subscale of the European Organization for Research and Treatment of Cancer Quality of Life-Cognitive Functioning Scale (EORTC-CF). Results Most participants were female (95%) breast cancer survivors (89%). Correlation of changes in the FACT-Cog and the EORTC-CF were 0.55 post-intervention and 0.61 at follow-up. Anchor-based CID estimates for the FACT-Cog using our primary anchor were 11.3 points (post) and 8.8 (follow-up), which corresponds to a standardized effect size of 0.49 and 0.38; 8.6% and 6.6% of the total scale’s range. Anchor-based CID estimates for the FACT-Cog PCI subscale were 7.4 (post) and 4.6 points (follow-up), which corresponds to a standardized effect size of 0.50 and 0.31; 10.3% and 6.4% of the PCI range). Empirical cumulative distribution functions of change in FACT-Cog demonstrating possible MCTs showed that anchor change of none, minimally better and much better were well separated. Conclusions The CID and MCT estimates from this manuscript can help in the design, analysis and interpretation of self-reported cognitive function in cancer patients and survivors.http://link.springer.com/article/10.1186/s41687-018-0071-4OncologyCancerChemotherapyCognitive impairmentQuality of lifeMinimal clinically important difference
spellingShingle M L Bell
H M Dhillon
V J Bray
J L Vardy
Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Journal of Patient-Reported Outcomes
Oncology
Cancer
Chemotherapy
Cognitive impairment
Quality of life
Minimal clinically important difference
title Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
title_full Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
title_fullStr Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
title_full_unstemmed Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
title_short Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
title_sort important differences and meaningful changes for the functional assessment of cancer therapy cognitive function fact cog
topic Oncology
Cancer
Chemotherapy
Cognitive impairment
Quality of life
Minimal clinically important difference
url http://link.springer.com/article/10.1186/s41687-018-0071-4
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