scholarly journals Minimal important differences of EORTC QLQ-C30 for metastatic breast cancer patients: Results from a randomized clinical trial

2022 ◽  
Author(s):  
Takuya Kawahara ◽  
Naruto Taira ◽  
Takeru Shiroiwa ◽  
Yasuhiro Hagiwara ◽  
Takashi Fukuda ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Minimal Important Differences

Abstract Purpose To establish minimal important differences (MIDs) for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) in patients with metastatic breast cancer. Methods The dataset was obtained from the SELECT BC-CONFIRM randomized clinical trial. Anchors obtained from patients (transition items) and clinicians (performance status) were used for anchor-based methods. Anchors obtained through 6 months after starting treatment were used for this analysis. Correlation coefficients of anchor and change in QLQ-C30 and effect size were used to qualify for estimating MIDs. Mean change method and generalized estimating equation were applied to estimate MIDs. Distribution-based methods were used for comparison. Results We analyzed a dataset of 154 metastatic breast cancer patients. MIDs were estimated in 8 of 15 scales of QLQ-C30. Estimated MIDs for within-group improvement varied from 7 to 15 and those for deterioration varied from − 7 to − 17. Estimated MIDs for between-group improvement varied from 5 to 11 and those for deterioration varied from − 5 to − 8 across QLQ-C30 scales. Patient-reported anchors were more susceptible to early changes in health status than clinician-reported anchors. Conclusion We provided the MIDs of the QLQ-C30 using both patient- and clinicians-reported anchors measured in a randomized trial of Japanese patients with metastatic breast cancer. We recommend patient-reported anchors for anchor-based estimation of MID. Our results can aid patients and clinicians, as well as researchers, in the interpretation of QLQ-C30.

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

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6589-6589
Author(s):  
Alexandre Chan ◽  
Yu Lee Foo ◽  
Maung Shwe Ham Guo ◽  
Yuan Chuan Kee ◽  
Yee Pin Tan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Minimal Clinically Important Difference ◽  
Cognitive Deterioration ◽  
Size Estimation ◽  
Breast Cancer Patients ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

6589 Background: Establishing the Minimal Clinically Important Difference (MCID) is essential for interpreting the clinical relevance of patient reported outcomes. This is the first study to date to determine the MCID of FACT-Cog, a 37-item validated subjective neuropsychological instrument designed to evaluate cancer patients’ perceived cognitive deterioration on their quality of life. Methods: This prospective, observational study involved 220 breast cancer patients who have completed FACT-Cog and EORTC-QLQ-C30 at two time points: baseline and at least 3 months following chemotherapy. The MCID was computed using 3 approaches: 1) an anchor-based approach utilized the validated EORTC-QLQ-C30-Cognitive Functioning scale (CF) as the anchor for patients who showed a minimal deterioration on the CF (defined as a one-step deterioration on the CF scale); 2) a Receiver Operating Characteristic (ROC) curve was used to identify an optimal MCID cut-off point for deterioration; 3) a distribution-based approach utilized the 0.33 SD, 0.5 SD and one standard error of measurement (SEM) of the total FACT-Cog score (148 points) to estimate the MCID. Results: There was moderate correlation between the mean change scores of FACT-Cog and CF (rp= 0.43, p<0.001). The CF-anchored MCID was 9.6 points (95% CI 4.4 - 14.8). MCID derived from the ROC method was 7.5 points (AUC: 0.75; sensitivity: 75.6%; specificity: 68.8%). Using the distribution-based approach, MCID corresponding to effect sizes of 0.33SD to 0.5SD of the total FACT-Cog score ranged from 6.9 – 10.3 points and one-SEM criterion resulted in a MCID estimate of 10.6 points. Combining results from all approaches, the MCID identified for FACT-Cog ranged from 6.9 – 10.6 points (4.7% to 7.2% of total score). Conclusions: A 6.9 to 10.6 points reduction of the FACT-Cog score corresponds to the smallest clinically-relevant perceived cognitive deterioration. These estimates are important as they can facilitate the interpretation of patient-reported cognitive changes and sample size estimation in future studies.

Oral silymarin formulation efficacy in management of AC-T protocol induced hepatotoxicity in breast cancer patients: A randomized, triple blind, placebo-controlled clinical trial

2021 ◽  
pp. 107815522110061
Author(s):  
Ghazal Sadat Askarpour Moezian ◽  
Seyed Alireza Javadinia ◽  
Soodabeh Shahid Sales ◽  
Azar Fanipakdel ◽  
Sepideh Elyasi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Liver Function ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Liver Function Tests ◽  
Controlled Clinical Trial ◽  
Breast Cancer Patients ◽  
Function Tests

Background Chemotherapeutic agents, with or without other drugs and radiation, may cause indirect or direct hepatotoxicity. Doxorubicin-induced hepatotoxicity (DIH) is a major health concern in cancer patients receiving this cytotoxic drug that is mostly resulted from the production of reactive oxygen species leading to transient or permanent liver damages. Silymarin, a flavonoid extracted from the Silybum marianum, exhibits antioxidant and anti-inflammatory activities. Purpose This study aimed to investigate the clinical efficacy of systemic administration of silymarin in management of chemotherapy induced hepatotoxicity in patients with non-metastatic breast cancer who received doxorubicin/cyclophosphamide-paclitaxel (AC-T) regimen. Material: In this randomized, triple blind, placebo-controlled clinical trial, 30 patients who received AC-T who fulfilled the inclusion criteria were randomly allocated to silymarin (n = 15) or placebo (n = 15) groups to receive oral silymarin 140 mg three times a day or placebo tablets, respectively. Fatty liver severity was assessed by liver ultrasound imaging and FibroScan® and also measurement of liver function tests before and after the intervention. Results There was a non-significant trend toward more severe liver involvement in placebo group comparing to the silymarin group after intervention based on ultrasonography (p = 0.083). Besides, in silymarin group, hepatic involvement grade based on ultrasonography considerably reduced after intervention (p = 0.012). However, no difference was found between two groups based on FibroScan and liver function tests. Conclusion Oral administration of silymarin could significantly reduce hepatotoxicity severity after 1 month of treatment in non-metastatic breast cancer patients treated with AC-T regimen.

scholarly journals Electronic-Based Patient-Reported Outcomes: Willingness, Needs, and Barriers in Adjuvant and Metastatic Breast Cancer Patients

JMIR Cancer ◽  
2017 ◽  
Vol 3 (2) ◽  
pp. e11 ◽  
Author(s):  
Andreas D Hartkopf ◽  
Joachim Graf ◽  
Elisabeth Simoes ◽  
Lucia Keilmann ◽  
Nina Sickenberger ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Patient Reported
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