Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma.

BACKGROUND: Hand-foot syndrome and mucositis/stomatitis are frequent adverse events (AEs) of treatment with tyrosine kinase inhibitors in cancer therapy. Quality-of-life instruments that measure the functional consequences of these AEs are needed to assess the impact of therapeutic interventions and to guide patient care. The Hand-Foot and Mucositis Symptom and Impact Questionnaire (HAMSIQ [formerly the Supplementary Quality of Life Questionnaire]) was used in the COMPARZ trial (Pazopanib vs Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma [national clinical trial no. NCT00720941]) and the PISCES study (Patient Preference Study of Pazopanib vs Sunitinib in Advanced or Metastatic Kidney Cancer [clinicaltrials.gov NCT01064310]) to assess mouth/throat and hand/foot soreness symptoms and subsequent limitations in patients receiving pazopanib or sunitinib for metastatic renal cell carcinoma. The objective of the current analysis was to validate the HAMSIQ using data from the PISCES study. METHODS: The HAMSIQ was administered in the PISCES study at baseline and every 2 weeks over two 10-week periods to patients who were receiving pazopanib or sunitinib. Data from the first 10-week period were used to assess the feasibility, validity, and responsiveness of the HAMSIQ. RESULTS: In total, ≥85% of 169 patients completed the HAMSIQ (excluding the item concerning days off work). Correlations among items within the same limitation subscale generally were high (Cronbach α ≥ .80). HAMSIQ limitation scores differentiated patients according to their baseline performance status and severity of soreness. Small-to-moderate correlations were observed for the symptoms/limitation scores and for changes from baseline scores between the HAMSIQ and the Functional Assessment of Chronic Illness Therapy fatigue survey. The HAMSIQ demonstrated responsiveness to changes in clinical status and the development of hand-foot syndrome AEs over time. CONCLUSIONS: The HAMSIQ is a feasible, valid, reliable, and responsive instrument for assessing the impact of hand-foot syndrome and mucositis in patients receiving tyrosine kinase inhibitors. Cancer 2016;122:287-295. © 2015 American Cancer Society.

Validation of the Japanese version of HFS-14, a disease-specific quality of life scale for patients suffering from hand-foot syndrome.

PURPOSE: The purpose of this study was to develop a Japanese version of hand-foot syndrome (HFS)-specific quality of life (QOL) questionnaire (HFS-14) to evaluate and monitor the QOL of patients with a possibility of HFS. METHODS: The original English version of HFS-14 was translated and slightly modified into Japanese, and the Japanese HFS-14 was administered to 187 patients receiving chemotherapy with high risk of developing HFS as outpatients in four institutions in Japan. Factor validity, internal consistency, correlation with the Skindex-16 and Dermatology Life Quality Index (DLQI) scores, known group validity, and test-retest reliability were analyzed for 105 patients who developed HFS. Next, we compared HFS-14 with DLQI and Skindex-16. RESULTS: Factor analysis confirmed the factor structure (one putative scale) of the Japanese HFS-14. Cronbach's alpha was over 0.90. The Japanese HFS-14 score was correlated with the Skindex-16 and DLQI score. Intra-class correlation coefficients were over 0.80. Patients with severe HFS reported significantly poorer HFS-14 score than those with mild HFS. The Skindex-16 and DLQI scores were also significantly different in patients with different Common Terminology Criteria for Adverse Events (CTCAE) grades, but with smaller effect sizes than those for the HFS-14 score. CONCLUSIONS: The Japanese HFS-14 provides a valid and reliable score for monitoring and evaluating HFS.

HFS-14, a specific quality of life scale developed for patients suffering from hand-foot syndrome.

BACKGROUND: Hand-foot syndrome (HFS) is a common reaction to certain chemotherapies and new targeted therapies, impairing patient quality of life (QoL). However, there is currently no specific tool to measure QoL in patients with HFS. Objective. The objective was to develop and validate a HFS-specific QoL questionnaire (HFS-14). PATIENTS AND METHODS: From a list of 31 items identified from a literature review and patient interview notes, item reduction and pilot testing by cognitive debriefing resulted in a final 14-item questionnaire with excellent internal reliability. Clinical validity was assessed in 43 patients with HFS by comparing the HFS-14 score according to HFS clinical grade based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0, and by measuring its correlation with the Dermatology Life Quality Index (DLQI), Skindex-16, and short-form 12 health-related questionnaires and pain measurement. RESULTS: The mean HFS-14 score was significantly higher in patients with clinical grade 2 and grade 3 HFS than in those with grade 1 HFS. The higher the HFS-14 score, the greater the QoL impairment. The HFS-14 score was highly correlated with the DLQI and Skindex-16 scores. In the population of patients with severe grade 3 NCI-CTCAE HFS, the HFS-14 score was significantly higher in patients having both hands and feet severely involved than in those with severe involvement of one limb (hands or feet) with the other one less severely affected. CONCLUSIONS: This scale specifically developed for patients with HFS is a valid and valuable tool for measuring HFS-related QoL impairment.

Unmet needs of cancer patients with chemotherapy-related hand-foot syndrome and targeted therapy-related hand-foot skin reaction: A qualitative study.

PURPOSE: The objective of this qualitative study was to understand the perceived needs of advanced-stage cancer patients with chemotherapy-related hand-foot syndrome (HFS) and/or targeted therapy-related hand-foot skin reaction (HFSR). METHOD: Face-to-face interviews were conducted with 20 outpatients with advanced/recurrent cancer and chemotherapy-related HFS and/or targeted therapy-related HFSR using a semi-structured interview guide at Keio University Hospital, Tokyo, Japan. Thematic analysis was used to analyse the data. RESULTS: The unmet needs of cancer patients with chemotherapy-related HFS and/or targeted therapy-related HFSR was identified through four themes: a sense of helplessness with persistent symptoms, noticeable appearance as a barrier to social participation, decreased willingness to work and continue treatment, and need of individual coping strategies. CONCLUSION: This study revealed unmet needs of cancer patients with chemotherapy-related HFS and/or targeted therapy-related HFSR that are not often voiced. Health care providers should provide full information in advance and find the best coping strategy for individual patients.

Hand-foot syndrome and its impact on daily activities in breast cancer patients receiving docetaxel-based chemotherapy.

PURPOSE: Breast cancer patients who undergo docetaxel-based chemotherapy regimens can have hand-foot syndrome (HFS), which negatively impacts their ability to perform daily activities. The purpose of the study was to assess, in breast cancer patients receiving chemotherapy: the perceived levels of HFS-related symptoms of the feet, hands or fingers; and HFS-related restrictions in daily activities; as well as to identify factors associated with these symptoms and restrictions. METHODS: This cross-sectional study examined breast cancer patients who received docetaxel-based chemotherapy from the general surgery outpatient department and oncology outpatient department of a medical center in northern Taiwan. A set of structured questionnaires were used to measure patients' HFS-related symptoms and HFS-related restrictions in daily activities. RESULTS: Of the 85 breast cancer patients studied, 41.2% reported HFS. Patients had higher level of HFS-related foot symptoms than HFS-related hand or fingers symptoms. Greater restriction in HFS-related daily activities was associated with more HFS-related hand or fingers symptoms and more HFS-related foot symptoms; these factors explained 44.7% of the variance in restriction of activities. CONCLUSION: Skin care and patient education should be provided to manage the HFS of breast cancer patients receiving chemotherapy.

Quality of life under capecitabine (Xeloda®) in patients with metastatic breast cancer: data from a german non-interventional surveillance study.

AIM: This non-interventional surveillance study (NIS) collected data on the quality of life (QoL) of patients treated with capecitabine as mono- or combination chemotherapy in an outpatient setting. METHODS: Capecitabine was administered orally for 14 days of each 21-day cycle. The main parameters of interest were QoL, compliance, patient and physician satisfaction, handling of hand-foot syndrome (HFS), and efficacy. The statistics were descriptive; some differences were compared using confidence intervals (CIs). RESULTS: 735 patients from 161 centers received at least 1 dose of capecitabine. The median duration of observation was 5.5 months overall. The QoL global score was 53% (mean from the entire study population at all times), without any correlation to HFS. The overall response rate (ORR) was 35.1%, and the disease control rate (DCR) 64.4%. The median progression-free survival (PFS) was overall 6.81 months (95% CI 6.32-7.63 months) and it was significantly higher in patients with HFS (8.4 months, 95% CI 7.5-9.2 months, hazard ratio (HR) 0.60; p < 0.0001). The safety and tolerability of capecitabine were considered acceptable. The HFS incidence (all grades) was 27.1%. CONCLUSIONS: Capecitabine had a favorable risk-benefit relation in outpatient therapy. The QoL remained stable over the course of the investigation, indicating good compliance. HFS was a strong predictor of longer PFS and had no negative impact on the global QoL.

Pyridoxine for prevention of hand-foot syndrome caused by chemotherapy: a systematic review.

BACKGROUND: Hand-foot syndrome (HFS) is a relatively frequent dermatologic toxic reaction to certain anti-cancer chemotherapies. The syndrome can evolve into a distressing condition that limits function and affects quality of life. Pyridoxine (vitamin B6) has been used empirically for the prevention of HFS caused by anti-cancer therapy. However, evidence of its efficacy remains controversial. METHODOLOGY//PRINCIPAL FINDINGS: Systematic literature searches were conducted on the Cochrane Library, PUBMED, EMBASE, LILACS, CBM, CNKI, VIP, WANFANG and the U.S. ClinicalTrials.gov website. We included all related randomized controlled trials (RCTs) irrespective of language. Reviewers from different professions independently assessed all potential studies and extracted data. Subgroup analysis was planned according to dose of pyridoxine. 5 RCTs involving 607 patients were contributed to the meta-analysis. No significant differences were found between patients receiving pyridoxine and placebo for prevention of incidence of HFS and grade 2 or worse HFS (relative risk (RR) 0.96, 95%confidence interval (CI) 0.86-1.06; RR0.95, 95%CI 0.73-1.24, respectively). Similarly, no significant improvement in quality of life was detected among patients. However, significant difference was found for prevention of grade 2 or worse HFS with pyridoxine 400 mg daily compared to 200 mg (RR0.55, 95%CI 0.33-0.92). CONCLUSIONS/SIGNIFICANCE: There is inadequate evidence to make any recommendation about using pyridoxine for prevention of HFS caused by chemotherapy. However, pyridoxine 400 mg may have some efficacy. Further studies of large sample sizes are needed to evaluate the efficacy and safety of pyridoxine, especially at high dose, in comparison with placebo.