Minimal clinically important difference (MCID) for the functional assessment of cancer therapy: Cognitive function (FACT-Cog) in breast cancer patients

Cheung, Yin Ting; Foo, Yu Lee; Shwe, Maung; Tan, Yee Pin; Fan, Gilbert; Yong, Wei Sean; Madhukumar, Preetha; Ooi, Wei; Chay, Wen Yee; Dent, Rebecca; Ang, Soo Fan; Lo, Soo Kien; Yap, Yoon Sim; Ng, Raymond; Chan, Alexandre

doi:10.1016/j.jclinepi.2013.12.011

Cited by 108 publications

(109 citation statements)

References 47 publications

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“…First, because this was an unplanned, secondary analysis, we relied on available self‐report data and did not have information from neuropsychological testing. However, the validity of self‐report is supported by correlation with the objectively measured Blessed Orientation‐Memory‐Concentration test in the current study sample and the results of past research and neuroimaging studies,6, 13, 14, 15, 16, 17 including reports of correlations between the EORTC cognition and Functional Assessment of Cancer Therapy‐Cognitive Function scales 46. Moreover, the analytic procedure makes assumptions regarding the equality of error variances across trajectories that could produce optimistic P values 35.…”

Section: Discussionsupporting

confidence: 54%

“…Moreover, the accelerated decline group experienced a 13.4‐point decline over time. This represents a clinically meaningful change,46, 47, 48 especially because those with extant cognitive problems were excluded from analysis. The baseline assessment could have occurred mid‐treatment for survivors undergoing chemotherapy, and therefore it is not possible to determine whether the accelerated decline group had low cognitive scores before therapy or experienced decrements early during treatment.…”

Section: Discussionmentioning

confidence: 99%

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Long‐term trajectories of self‐reported cognitive function in a cohort of older survivors of breast cancer: CALGB 369901 (Alliance)

Mandelblatt

Clapp

Luta

et al. 2016

Cancer

138

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BACKGROUNDThe number of survivors of breast cancer aged ≥65 years (“older”) is growing, but to the authors' knowledge, little is known regarding the cognitive outcomes of these individuals.METHODSA cohort of cognitively intact older survivors with nonmetastatic, invasive breast cancer was recruited from 78 sites from 2004 through 2011; approximately 83.7% of the survivors (1280 survivors) completed baseline assessments. Follow‐up data were collected at 6 months and annually for up to 7 years (median, 4.1 years). Cognitive function was self‐reported using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ‐C30); scores ranged from 0 to 100, with a higher score indicating better function. Group‐based trajectory modeling determined trajectories; women were assigned to a trajectory group based on the highest predicted probability of membership. Multinomial logistic regression evaluated the association between receipt of chemotherapy (with or without hormonal treatment) and trajectory group.RESULTSSurvivors were aged 65 to 91 years; approximately 41% received chemotherapy. There were 3 cognitive trajectories: “maintained high” (42.3% of survivors); “phase shift” (50.1% of survivors), with scores slightly below but parallel to maintained high; and “accelerated decline” (7.6% of survivors), with the lowest baseline scores and greatest decline (from 71.7 [standard deviation, 19.8] to 58.3 [standard deviation, 21.9]). The adjusted odds of being in the accelerated decline group (vs the maintained high group) were 2.1 times higher (95% confidence interval, 1.3‐3.5) for survivors who received chemotherapy (with or without hormonal therapy) versus those treated with hormonal therapy alone. Greater comorbidity and frailty also were found to be associated with accelerated decline.CONCLUSIONSTrajectory group analysis demonstrated that the majority of older survivors maintained good long‐term self‐reported cognitive function, and that only a small subset who were exposed to chemotherapy manifested accelerated cognitive decline. Future research is needed to determine factors that place some older survivors at risk of experiencing cognitive decline. Cancer 2016;122:3555–3563. © 2016 American Cancer Society

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Section: Discussionsupporting

confidence: 54%

Section: Discussionmentioning

confidence: 99%

Long‐term trajectories of self‐reported cognitive function in a cohort of older survivors of breast cancer: CALGB 369901 (Alliance)

Mandelblatt

Clapp

Luta

et al. 2016

Cancer

138

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“…19 In patients with breast cancer, 45.2% reported a perceived decline in FACT-Cog scores compared with 10.4% of controls (P , .001; Fig 3). From postchemotherapy to 6-months follow-up, 18.4% of patients with breast cancer reported clinically meaningful perceived decline in FACT-Cog scores compared with 11.5% in controls.…”

Section: Prevalence Of Clinically Meaningful Perceived Cognitive Impamentioning

confidence: 91%

“…A 1/2 standard deviation as a possible cutoff for a minimal clinically important difference (MCID) has been identified for this measure. 19 Reading ability-a proxy for cognitive reserve-was assessed by the Wide Range Achievement Test, 4th Edition (WRAT-4) reading subscale. 20 Anxiety was assessed with the Spielberger State/Trait Anxiety Inventory State score (form Y-1).…”

Section: Methodsmentioning

confidence: 99%

“…Group comparisons of change over time were assessed with Welch t tests and were expressed as effect sizes. We calculated percentages of improvement, decline, or no change on the basis of a 1/2 standard deviation MCID 19 over time from assessment 1 to assessment 2, assessment 2 to assessment 3, and assessment 1 to assessment 3. In our study, the MCID was a decrease of $ 13.8 points in FACT-Cog using the standard deviation for controls at baseline.…”

Section: Statistical Analysesmentioning

confidence: 99%

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Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study

Janelsins

Heckler

Peppone

et al. 2017

JCO

315

292

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Cancer-related cognitive impairment is an important problem for patients with breast cancer, yet its trajectory is not fully understood. Some previous cancer-related cognitive impairment research is limited by heterogeneous populations, small samples, lack of prechemotherapy and longitudinal assessments, use of normative data, and lack of generalizability. We addressed these limitations in a large prospective, longitudinal, nationwide study. Patients and MethodsPatients with breast cancer from community oncology clinics and age-matched noncancer controls completed the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at prechemotherapy and postchemotherapy and at a 6-month follow-up as an a priori exploratory aim. Longitudinal models compared FACT-Cog scores between patients and controls at the three assessments and adjusted for age, education, race, menopausal status, and baseline reading ability, anxiety, and depressive symptoms. A minimal clinically important difference cutoff determined percentages of impairment over time. ResultsOf patients, 581 patients with breast cancer (mean age, 53 years; 48% anthracycline-based regimens) and 364 controls (mean age, 53 years) were assessed. Patients reported significantly greater cognitive difficulties on the FACT-Cog total score and four subscales from prechemotherapy to postchemotherapy compared with controls as well as from prechemotherapy to 6-month follow-up (all P , .001). Increased baseline anxiety, depression, and decreased cognitive reserve were significantly associated with lower FACT-Cog total scores. Treatment regimen, hormone, or radiation therapy was not significantly associated with FACT-Cog total scores in patients from postchemotherapy to 6-month follow-up. Patients were more likely to report a clinically significant decline in self-reported cognitive function than were controls from prechemotherapy to postchemotherapy (45.2% v 10.4%) and from prechemotherapy to 6-month follow-up (36.5% v 13.6%). ConclusionPatients with breast cancer who were treated in community oncology clinics report substantially more cognitive difficulties up to 6 months after treatment with chemotherapy than do age-matched noncancer controls.

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Managing Cancer and Living Meaningfully (CALM) alleviates chemotherapy related cognitive impairment (CRCI) in breast cancer survivors: A pilot study based on resting‐state fMRI

et al. 2023

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BackgroundChemotherapy related cognitive impairment (CRCI) is a type of memory and cognitive impairment induced by chemotherapy and has become a growing clinical problem. Breast cancer survivors (BCs) refer to patients from the moment of breast cancer diagnosis to the end of their lives. Managing Cancer and Living Meaningfully (CALM) is a convenient and easy‐to‐apply psychological intervention that has been proven to improve quality of life and alleviate CRCI in BCs. However, the underlying neurobiological mechanisms remain unclear. Resting‐state functional magnetic resonance imaging (rs‐fMRI) has become an effective method for understanding the neurobiological mechanisms of brain networks in CRCI. The fractional amplitude of low‐frequency fluctuations (fALFF) and ALFF have often been used in analyzing the power and intensity of spontaneous regional resting state neural activity.MethodsThe recruited BCs were randomly divided into the CALM group and the care as usual (CAU) group. All BCs were evaluated by the Functional Assessment of Cancer Therapy Cognitive Function (FACT‐Cog) before and after CALM or CAU. The rs‐fMRI imaging was acquired before and after CALM intervention in CALM group BCs. The BCs were defined as before CALM intervention (BCI) group and after CALM intervention (ACI) group.ResultsThere were 32 BCs in CALM group and 35 BCs in CAU group completed the overall study. There were significant differences between the BCI group and the ACI group in the FACT‐Cog‐PCI scores. Compared with the BCI group, the ACI group showed lower fALFF signal in the left medial frontal gyrus and right sub‐gyral and higher fALFF in the left occipital_sup and middle occipital gyrus. There was a significant positive correlation between hippocampal ALFF value and FACT‐Cog‐PCI scores.ConclusionsCALM intervention may have an effective function in alleviating CRCI of BCs. The altered local synchronization and regional brain activity may be correlated with the improved cognitive function of BCs who received the CALM intervention. The ALFF value of hippocampus seems to be an important factor in reflect cognitive function in BCs with CRCI and the neural network mechanism of CALM intervention deserves further exploration to promote its application.

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Minimal clinically important difference (MCID) for the functional assessment of cancer therapy: Cognitive function (FACT-Cog) in breast cancer patients

Cited by 108 publications

References 47 publications

Long‐term trajectories of self‐reported cognitive function in a cohort of older survivors of breast cancer: CALGB 369901 (Alliance)

Long‐term trajectories of self‐reported cognitive function in a cohort of older survivors of breast cancer: CALGB 369901 (Alliance)

Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study

Managing Cancer and Living Meaningfully (CALM) alleviates chemotherapy related cognitive impairment (CRCI) in breast cancer survivors: A pilot study based on resting‐state fMRI

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