Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study.

BACKGROUND: We recently reported that self-evaluation of the incidence and severity of treatment-related side effects (TSEs) using a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0-based questionnaire was feasible and more informative than doctor reports in patients undergoing standard adjuvant chemotherapy for operable breast cancer. Here, we compare self- and doctor-evaluated day of onset and duration of TSEs in the same population. PATIENTS AND METHODS: Six hundred and four patients were enrolled at 11 sites in Italy. CTCAE v4.0 definitions of grade of severity of nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third chemotherapy cycles. At each time-point, information on TSEs was extracted from the medical charts and compared to patient questionnaires. RESULTS: A total of 594 and 573 paired patient and doctor questionnaires were collected after cycles one and three, respectively. TSE duration was significantly longer when reported by patients compared to doctors for six and seven of ten items after cycles one and three, respectively. Due to the combined effect of doctor underreporting of TSE incidence and duration, the mean percentages of cycle days with TSEs were significantly higher for all ten items when based on patient reports. Day of onset could not be evaluated because of insufficient numbers of complete records. CONCLUSIONS: Self-reporting TSE duration is feasible using a CTCAE-derived questionnaire. As doctors tend to underestimate TSE incidence and duration, patient-reported outcomes should be incorporated into clinical practice, perhaps using eHealth technologies, to harness their potential to better estimate total TSE burden.

[Italian validation of the Chemotherapy Induced Taste Alteration Scale]. / Validazione italiana della Chemotherapy induced Taste Alteration Scale (CiTAS).

UNLABELLED: . Italian validation of the Chemotherapy Induced Taste Alteration Scale. Introdution. Taste alterations (TAs) are an underestimated side effect despite affecting 75% of chemo-radiotherapy patients. TAs may cause discomfort and food aversions up to loss of appetite and anorexia. The available instruments do not discriminate the different types of TAs. AIM: The aim of the study is to validate the Italian version of CiTAS, a 18-items scale that assesses specific TAs, symptoms of discomfort and their impact on patient nutrition. METHODS: A convenience sample of 243 patients with chemotherapy-induced taste alterations were enrolled. Data were analyzed for item consistency using Cronbach alpha and construct validity using factor analysis. RESULTS: The factor analysis identified four dimensions that explained a total variance of 67%: decline in basic taste, discomfort, phantogeusia and parageusia, and general taste alterations. The scale showed good validity (Cronbach's alpha = 0.82). CONCLUSIONS: The CiTAS enabled the valid and reliable measurement of specific symptoms of chemotherapy-induced TAs. It can be used both as a clinical tool and in future studies to evaluate the effectiveness of specific TAs treatments.

Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer.

IMPORTANCE: Patient perspective on chemotherapy-related adverse effects is being increasingly acknowledged both in experimental clinical trials and in clinical practice. OBJECTIVE: To evaluate a 10-item, paper questionnaire derived from the US National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for patient-reported chemotherapy-related adverse effects. DESIGN, SETTING, AND PARTICIPANTS: Prospective, single-arm study of 604 women with breast cancer receiving standard adjuvant chemotherapy conducted at 11 outpatient oncology clinics at academic and nonacademic Italian hospitals between January 2011 and October 2013. The CTCAE version 4.0 definitions of grade of severity for nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third cycle of chemotherapy. Adverse effect information was also extracted from the medical records to compare with patient-reported data. MAIN OUTCOMES AND MEASURES: Differences in adverse effect-reporting between paired questionnaires and agreement between patient and physician adverse effect-reporting (grade 0 vs grade ≥1) were studied. Linear regression was used to study the effect of the number of patients enrolled at each institution on the magnitude of discrepancy in adverse effect-reporting between patients and physicians. RESULTS: A total of 604 women (median age, 53.4 years; interquartile range, 45.0-62.7 years) were enrolled. The number of patients enrolled at each site varied between 6 and 236. Three patients withdrew consent prior to starting the first cycle of adjuvant chemotherapy. After cycle 1 of adjuvant chemotherapy, 596 patient questionnaires were collected, and 581 patient questionnaires were collected after cycle 3. Of the questionnaires collected, 594 and 573 had corresponding questionnaire results extracted from medical records at the same time point. The median (interquartile range) percentage of completed questionnaire fields was 82% (80%-88%) for both the first and third cycle questionnaires, and the results of the 2 patient questionnaires showed a reduction in vomiting (severity), diarrhea (both incidence and severity), and pain (both incidence and severity), as well as a statistically significant increase in dysgeusia (both incidence and severity) and dyspnea (both incidence and severity) in the second patient-completed questionnaire. The frequency and severity of chemotherapy-related adverse effects were consistently greater in patient-reported data than physician-reported data. As a result, interrater agreement was low for most adverse effects, ranging from 0.10 for anorexia to 0.54 for vomiting (Cohen κ statistic). There was a strong and significant positive correlation between the magnitude of the discrepancy in the frequency of reporting adverse effects and the number of patients enrolled at each site. CONCLUSIONS AND RELEVANCE: Adherence to reporting adjuvant chemotherapy-related adverse effects using the CTCAE system is high in women undergoing adjuvant chemotherapy for breast cancer. Workload may contribute to agreement discrepancies by limiting the physician-patient relationship.

Restless legs syndrome as a cause of sleep disturbances in cancer patients receiving chemotherapy.

CONTEXT: Sleep disturbances are frequent in cancer patients during chemotherapy; the contributory role of restless legs syndrome (RLS) in this setting has never been assessed. OBJECTIVES: This study investigated the role of RLS in causing sleep disturbances and altering the quality of life in cancer patients during chemotherapy. METHODS: Evaluation tools included the Pittsburgh Sleep Quality Index (PSQI), the RLS questionnaires, the Functional Assessment of Cancer Therapy-General, and the Hospital Anxiety and Depression Scale for quality of life and anxiety/depression assessment. The study population was 173 cancer patients. The questionnaires were administered during the third chemotherapy cycle. Patients positive for RLS were reassessed six months after the end of chemotherapy. RESULTS: In all, 58.8% of patients reported experiencing sleep disturbances (PSQI≥5) and 20% screened positive for RLS. Neither sleep disturbances nor RLS was associated with anemia, neurotoxic cytotoxic drugs, or benzamide treatment. A direct relationship was found between the PSQI and RLS (P=0.007); both PSQI and RLS scores were significantly associated with poor quality of life (P=0.008 and 0.01, respectively) and anxiety (P=0.0001 and 0.01, respectively). PSQI score also was associated with depression (P=0.0001). RLS persisted in four of the 25 RLS-positive patients reassessed at six months after chemotherapy. RLS recovery was associated with a significant reduction in sleep disturbances and improvement in quality of life. CONCLUSION: RLS can be a contributory factor in sleep disturbances in cancer patients undergoing chemotherapy. Screening for RLS could aid in tailoring a potentially more efficacious treatment of such disturbances.