Quality Of Life Questionnaire C30 Research Articles

Health utilities in cancer patients: A study protocol for a prospective, longitudinal cohort using online survey.

Background:Cost-utility analysis (CUA) is becoming more commonly used in healthcare decision-making. CUA uses the quality-adjusted life-years (QALY) metric, which combines the length of life with the health-related quality of life (HRQoL). Most QALY-measuring instruments were validated for general populations. For patients with cancer, the perception of their health state is different and may vary by the type of cancer considered. In Quebec, no preference weights for QALY have been developed, neither for the general population nor particular subpopulations.Methods/design:This survey is a prospective, longitudinal cohort study. The study objectives are: to assess the extent of difference in health utilities between the general population and patients with breast or colorectal cancer; to develop a QALY preference weights dataset for patients with cancer; and to perform “mapping” with different HRQoL questionnaires by correlating the SF-6Dv2 with the EQ-5D-5L, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, and functional assessment of cancer therapy - general questionnaires. Data will be collected via a self-administered online survey. Patients’ health utilities will be measured within 2 days before the beginning of a chemotherapy treatment cycle and about 8 days after the start of the chemotherapy. Health utilities will be measured by a hybrid method using the time-trade-off and discrete choice experiment methods.Ethics and dissemination:The proposed research was reviewed and approved by the Institutional Research Ethics Review Boards of the CHUS. We will disseminate our study findings through peer-reviewed publications and conference presentations.

Abstract OT3-03-02: A phase 2, open-label, single-arm, multi-center study of talazoparib for neoadjuvant treatment of germline BRCA1/2 mutation patients with early-stage triple-negative breast cancer (TNBC)

Abstract Background: Approximately 15% of all breast cancers are triple negative and deleterious BRCA1/2 mutations are found in ˜11% of unselected TNBC. In the phase 3 EMBRACA trial (NCT01945775), the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib was superior to chemotherapy in prolonging progression-free survival in BRCA1/2 mutation patients with advanced breast cancer. A recent pilot study (NCT02282345) of 20 patients, explored the feasibility of neoadjuvant talazoparib in BRCA1/2 mutation patients; pathologic complete response (pCR) was reported at 53% with 6 months of single agent talazoparib. Trial Design: This phase 2, single-arm, open-label, multi-center study has a Simon 2-stage design. Eligible pts have stage I-III invasive TNBC (ER and PR <10%), with germline BRCA1/2 mutations who are suitable for neoadjuvant therapy. Pts will receive talazoparib 1 mg daily for 24 weeks, followed by breast surgery, which should occur within 4 to 6 weeks of the last dose. Ultrasound will be performed serially to assess tumor response. The primary objective is to evaluate pCR after 24 weeks of neoadjuvant talazoparib. pCR (ypT0/is ypN0) will be assessed by independent central review. Safety will also be assessed. Pts will be followed for at least 5 years to assess long term outcomes (event-free and overall survival). After surgery, any further adjuvant therapy will be given at the discretion of the treating physician. Pt reported outcomes will be assessed electronically including the global health status/quality of life, functions, and symptoms using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires C30 and BR23. Plasma pharmacokinetic (PK) samples for determination of talazoparib concentrations will be collected at defined timepoints to describe the steady-state PK of talazoparib. Exploratory biomarker research will also take place. Approximately 122 men and women will be enrolled in the study, of which 112 evaluable pts are planned. With 112 evaluable pts and one interim futility look, the null hypothesis that the true pCR rate is 35% will be tested against a 1-sided alternative. This design yields a 1-sided type 1 error rate of 2.5% and power of 90% when the true pCR rate is 50%. An interim analysis will be performed to evaluate the efficacy of talazoparib after 28 evaluable pts undergo talazoparib treatment for 24 weeks, followed by surgery, and are assessed for pCR by central review. This trial is currently recruiting and is registered at clinicaltrials.gov (NCT03499353). Funding: This study is sponsored by Pfizer, Inc. Citation Format: Litton J, Symmans F, Gogineni K, Saltzman M, Telli ML, Usha L, Chakrabarti J, Tudor IC, Quek RG, Czibere A. A phase 2, open-label, single-arm, multi-center study of talazoparib for neoadjuvant treatment of germline BRCA1/2 mutation patients with early-stage triple-negative breast cancer (TNBC) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT3-03-02.

Similar Quality of Life with 5mg Versus 25mg Lenalidomide Maintenance after First-Line High-Dose Therapy and Autologous Blood Stem Cell Transplantation for Multiple Myeloma: Results of the Lenamain Trial

Introduction The LenaMain study is a prospective, randomized, open label, multicenter phase III trial which included 188 patients 3 months after first-line high dose treatment and autologous stem cell transplantation (NCT number:NCT00891384). Patients were equally randomized to receive either 25 (n = 94, arm A) or 5 mg (n = 94, arm B) lenalidomide maintenance until disease progression following a uniform 6 months of 25 mg lenalidomide consolidation. Final analysis after follow-up of 46.7 months was presented at ASCO 2018 (#8016) demonstrating an extended event-free survival for arm A (11.8 months, p=0.032) and an about 10% increase of grade 3/4 infections per year as main toxicity. Here we report analysis of quality of life (QoL) data as secondary endpoint of the study. Materials & Methods The EORTC Quality of Life Questionnaire C30 (QLQ-C30) was collected at baseline and then monthly at every new cycle. The Global Health Status/Quality of Life (GHS/QoL) scale, the utility score and seven subscales (fatigue, nausea and vomiting, pain, physical functioning, role functioning, disease symptoms, and adverse effects of treatment) were compared between groups using a mixed model for repeated measures. Results Baseline questionnaire compliance was excellent (95.7%) and declined over time (82%, 76%, 71%, 54%, 49% after consolidation and after year 1, 2, 3 and 4 of maintenance, respectively). At baseline, GHS/QoL (67/67) and utility (0.73/0.72) scores for arm A/B were generally high and did not differ between both arms. The median GHS/QoL change between consolidation baseline and maintenance baseline was -1%. GHS/QoL scores appear constant for both treatment arms at most time points in the first 2 years of maintenance. Relevant improvements ≥ 5 points were observed in 30% of patients while improvements ≥ 15 points were observed in 20% of patients. During the same time a similar percentage of patients had relevant ≥ 5 and ≥15 point deteriorations, with a general tendency for a slight increase at the end of year 2. Notably, a greater number of deteriorations was found in the 5 mg lenalidomide arm. Mean GHS/QoL was constant during maintenance with a slight decrease of Utility values remained constant during maintenance (change from baseline 0.003, p=0.9 at year 1; 0.02, p=0.7 at year 2) and the overall pattern in the change over time does not appear to show any clear differences between the two treatment arms. Looking at QLQ-C30 subgroup domains after two years of maintenance, we observed a significantly higher change from baseline for diarrhea in the 25 mg lenalidomide arm, which may be a long-term drug-related effect. Conversely, role functioning was also significantly better in patients treated within the 25 mg lenalidomide arm. Other subgroups did not show significant differences after the second year. Overall GHS/QOL scores were not significantly different in patients with CR vs. ≥ vgPR. Similarly, there was no statistical difference in patients on treatment for 1, 2, 3 or 4 years of maintenance or in patients suffering from grade 3/4 adverse events or not. Thus, neither disease activity, nor duration of treatment nor high-grade toxicity biased our results. Conclusion The LenaMain trial shows that maintenance treatment with 25 mg lenalidomide vs. 5 mg significantly prolongs event-free survival. QoL, as secondary objective, was not different between both treatment arms, even showing a trend for improved QoL in the 25 mg lenalidomide treatment arm. Thus, QoL was not governed by the higher rate of infectious toxicity during high-dose lenalidomide maintenance. Disclosures Boquoi:Amgen: Honoraria, Other: Travel grant; Bristol-Myers Squibb: Honoraria; Janssen: Other: Travel grant; Celgene: Other: Travel grant. Goldschmidt:Celgene: Consultancy, Honoraria, Research Funding; Chugai: Honoraria, Research Funding; ArtTempi: Honoraria; Takeda: Consultancy, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Research Funding; Novartis: Honoraria, Research Funding; Mundipharma: Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Research Funding; Adaptive Biotechnology: Consultancy. Rummel:Gilead: Honoraria, Membership on an entity9s Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding; Mundipharma: Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding; Astellas: Honoraria; Janssen: Honoraria, Membership on an entity9s Board of Directors or advisory committees; Eisai: Honoraria; Celgene: Honoraria; Amgen: Honoraria, Membership on an entity9s Board of Directors or advisory committees; Symbio: Honoraria. Kroeger:Sanofi: Honoraria; JAZZ: Honoraria; Novartis: Honoraria, Research Funding; Neovii: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Riemser: Honoraria, Research Funding. Mai:Celgene: Other: travel grant; Janssen: Honoraria, Other: Travel grant; Takeda: Honoraria, Membership on an entity9s Board of Directors or advisory committees, Other: Travel grant, Research Funding; Onyx: Other: travel grant; Mundipharma: Other: travel grant. Kobbe:Amgen: Honoraria, Research Funding; Roche: Honoraria, Research Funding; Celgene: Honoraria, Other: Travel Support, Research Funding. Fenk:Amgen: Honoraria; Takeda: Honoraria; Celgene: Honoraria, Other: Travel grant, Research Funding; Bristol-Meyers Squibb: Honoraria, Other: travel grant; Janssen: Honoraria.

Correlation between MPN-SAF TSS and EORTC QLQ-C30 Scores in Patients with PV: Data from the Reveal Study

▪IntroductionPolycythemia vera (PV) is characterized by clonal proliferation of myeloid cells and erythrocytosis. Patients with PV often present with symptoms or develop symptoms that may negatively impact quality of life (QOL). In clinical trials, the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) have both been used to assess symptom burden in patients with PV. This analysis was conducted in patients with PV enrolled in REVEAL, a multicenter, prospective, observational trial, in an attempt to corroborate previous work by Emanuel et al (J Clin Oncol 2012;30:4098), which demonstrated associations between the MPN-SAF TSS and EORTC QLQ-C30.MethodsPatients ≥ 18 years of age with PV were enrolled and followed during usual care visits for ≤ 36 months. Patient-reported outcomes, including the MPN-SAF TSS and EORTC QLQ-C30, were collected at enrollment and at approximate 3-month intervals; only the forms completed at the time of enrollment were included in this analysis. MPN-SAF TSS items are scored on a linear analog scale ranging from 0 (absent) to 10 (worst imaginable), and individual symptom scores were added together to calculate a TSS; higher scores represent worse symptom burden. In the EORTC QLQ-C30, 28 questions are scored using a 4-point scale indicating frequency: 1 (not at all), 2 (a little bit), 3 (quite a bit), and 4 (very much); this includes 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Two questions on overall health and QOL are rated on a 1 (very poor) to 7 (excellent) scale. Five multi-item functional scales (physical, role, cognitive, emotional, and social), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), and a multi-item global health status/QOL scale are derived from the 30 questions. Linear transformation to 0-100 was applied to raw scores to obtain scores for each scale or single item. Higher scores for functional scales and global health status represent higher functioning and better health status/QOL, respectively. Higher scores for symptom scales/items represent higher symptom burden. Pearson correlation coefficient was used to assess correlations between MPN-SAF TSS and EORTC QLQ-C30 scales.ResultsAs of data cutoff (April 30, 2018), 2,298 of 2,510 enrolled patients (91.6%) had completed both MPN-SAF TSS and EORTC QLQ-C30 forms at enrollment. Median age was 67 years (range, 22-97 years), 54.0% were male, and 89.7% were Caucasian. Median disease duration at the time of enrollment was 4.1 years. The majority (52.5%) of patients were treated with hydroxyurea (28.7%) or hydroxyurea with phlebotomy (23.8%). The mean MPN-SAF TSS was 18.7 (out of 100) compared to 21.8 reported by Emanuel et al 2012. The 4 symptoms with the highest mean scores were fatigue (3.5), early satiety (2.6), inactivity (2.5), and itching (2.3). The QLQ-C30 mean scores for overall QOL and health were 5.5 and 5.3, respectively. EORTC QLQ-C30 symptom scales were highest for fatigue (29.9), insomnia (28.7), and pain (20.0).Correlation between MPN-SAF TSS and EORTC QLQ-C30 results showed stronger associations between multiple items (Table). Calculated TSS had the strongest association with fatigue (r = 0.72), pain (r = 0.59), cognitive functioning (r = -0.58), and emotional functioning (r = -0.58). Problems with concentration in the MPN-SAF TSS was moderately correlated with cognitive functioning (r = -0.70) in the EORTC QLC-C30. Fatigue assessments were also moderately correlated (r = 0.65) between the MPN-SAF TSS and EORTC QLQ-C30.ConclusionsIn this analysis of prospectively gathered real-world data, the MPN-SAF TSS results confirm that patients with PV experience a recognizable constellation of symptoms, including fatigue, early satiety, inactivity, and itching. Not surprisingly, PV-related symptoms have a negative impact on QOL. There were moderate correlations (r = 0.5-0.75) between the MPN-SAF TSS and the EORTC QLC-C30 with respect to global health status/QOL, the 5 functional scales, and fatigue, pain, and dyspnea. Consistent with the previous analysis, this analysis provides further evidence that the MPN-SAF TSS represents an accurate, yet simple tool to assess PV-related symptoms and their potential impact on QOL. [Display omitted] DisclosuresAltomare:Novartis: Consultancy; Incyte: Consultancy; Amgen: Consultancy; Bayer: Consultancy; Genentech: Consultancy; Celgene: Other: Advisory Board Member; Ipsen: Other: Advisory Board Member. Gerds:Celgene: Consultancy; Apexx Oncology: Consultancy; Incyte: Consultancy; CTI Biopharma: Consultancy. Lessen:Abbvie: Honoraria; Teva: Honoraria, Speakers Bureau; Incyte: Honoraria, Research Funding, Speakers Bureau; Astellas: Research Funding; Bayer: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Portola: Honoraria, Speakers Bureau; Janssen: Research Funding. Colucci:Incyte: Employment, Equity Ownership. Parasuraman:Incyte: Employment, Equity Ownership. Paranagama:Incyte: Employment, Equity Ownership. Mesa:Pfizer: Research Funding; Incyte Corporation: Research Funding; Gilead: Research Funding; Promedior: Research Funding; NS Pharma: Research Funding; Celgene: Research Funding; Novartis: Consultancy; UT Health San Antonio - Mays Cancer Center: Employment; CTI Biopharma: Research Funding; Genentech: Research Funding.

Mitchell–Hoole–Kanatas (MHK) questionnaire: the first to measure patient-reported outcomes relating to problems with intimacy after diagnosis and treatment of head and neck cancer

Patient-reported outcomes are increasingly used by clinical teams as indicators of quality when assessing treatment after a diagnosis of head and neck cancer. About a third of patients report reduced sexual interest or enjoyment after such treatment but, despite that, there is no questionnaire about intimacy that has been developed specifically for them. The aim of this study was to develop such a questionnaire, to gain an indication of the relative incidence of individual items, and to compare characteristics such as age, stage, treatment, time since treatment for an established head and neck cancer, and a health-related quality of life (QoL) measure (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 with the Head and Neck 35 module). The development of the new instrument was based on an exploratory observational study that included quantitative and qualitative methods. The qualitative element was achieved by the generation of items - from published studies, the comments of patients and carers, and a cross-sectional survey of patients with head and neck cancer who were alive and free of disease. The quantitative element comprised analysis of exploratory and confirmatory factors, internal reliability assessment (Cronbach’s alpha), and a correlation analysis. Forty-two patients were included in the focus groups, and 101 patients participated in the cross-sectional survey (both male and female, in a relationship and single, age range 30–70 years for the focus group, and 62–117 in the cross-sectional survey). All treatments were included. We found that the ability to enjoy a sex life had been adversely affected in about half the sample and that this had significantly changed from before their cancer in a third. The qualitative part of the study resulted in 22 items that covered a range of domains from dry mouth and thick saliva to loss of sensation (lips, fingertips), restricted head/neck movement, fatigue, and pain. The exploratory analysis covered four domains (physical, sensation, movement, and communication) from 12 of 22 items. Cronbach’s alphas ranged from 0.62 to 0.84, and the correlation analysis indicated “good fit” statistics for these domains. In terms of the EORTC QoL Questionnnaire – Head and Neck 35, the four MHK domains showed good levels of association with anticipated domains. Head and neck cancer and its associated treatments significantly adversely affect intimacy and sexuality in half the population sampled. The MHK tool may be used to identify specific issues related to intimacy in patients with a history of diagnosis and treatment of head and neck cancer. Further work is essential to identify its precise role and to help develop specific interventions.

Analysis of the clinical therapeutic effect of thoracoscopy and laparoscopy combined radical operation for esophageal carcinoma

Objective To explore the clinical therapeutic effect of thoracoscopy and laparoscopy combined radical operation for esophageal carcinoma and provide reference for clinical treatment. Methods The clinical data of five hundred and twenty-one patients with esophageal cancer in Kunming General Hospital of PLA from June 2010 to May 2017 were analyzed retrospectively. The patients were divided into experimental group (n=276) and control group (n=245) according to the type of procedure. The experimental group was treated with thoracoscopy and laparoscopy, and the control group was treated with open esophagectomy. The intra-operative condition (surgery time, intraoperative blood loss), postoperative condition (postoperative drainage volume, postoperative catheterization time, postoperative hospital stay), postoperative complications (pulmonary infection, anastomotic fistula, recurrent nerve paralysis, chylothorax, gastric emptying delayed, pleural effusion, incisal infection) and life quality [quality of life questionnaire C30 (QLQ-C30) version 3.0 core, quality of life questionnaire- OES18 (QLQ-OES18)] were compared between the two groups. The measurement data were expressed by (±s) and the two group were compared with the t test. The count data were expressed by percentage (%) and inter-group comparisons were performed by chi-square test between the two groups. Results The operation time [(238.7±32.4) min vs (245.1±34.6) min], period of catheter indwelling [(5.7±1.2) d vs (8.7±2.6) d]and hospital stay [(9.6±2.7) d vs (11.4±4.6) d] were shorter, the amount of intraoperative bleeding [(198.6±41.2) ml vs (231.9±43.5) ml] and post-operation drainage [(221.7±32.1) ml vs (257.8±38.6) ml] were less, and the morbidity of lung infection, anastomotic fistula and incision infection were lower in the experimental group than in the control group. The scores of emotional function, physical function and overall health status which belong to QLQ-C30 scale were higher and the scores of difficulty in feeding, reflux, pain, loss of appetite and cough which belong to QLQ-OES18 were lower in the experimental group than in the control group. The differences between the two groups had statistical significance (P<0.05). Conclusion Compared with open esophagectomy, thoracoscopy and laparoscopy combined radical operation for esophageal carcinoma has an advantage in improving the intra-operative and postoperative condition, reducing the postoperative complication rate and enhancing the postoperative life quality. Key words: Esophageal neoplasms; Thoracoscopes; Laparoscopes; Surgical procedures, operative; Clinical efficacy

Clinical assessment of palliative radiotherapy for pancreatic cancer

PurposeTo evaluate the feasibility and response to radiotherapy for improving the symptoms and quality of life in patients with pancreatic cancer. Patients and methodsWe enrolled 31 eligible patients (20 men, 11 women) with pancreatic cancer who were receiving radiotherapy from February 2012 to February 2014. The prescribed dose was 40 to 42Gy delivered to the planning target volume in seven to ten fractions of 4 to 6Gy. Patients completed Brief Pain Inventory (BPI), Functional Assessment Of Cancer Therapy-Hepatobiliary (FACT-Hep), and European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire C30 (EORTC QLQ-C30) one week prior to radiotherapy, and one and three months after treatment. The main outcome was the evaluation of the proportion of patients with less pain and reduced clinical symptoms after one month of radiotherapy compared to before treatment according to the BPI, FACT-Hep and EORTC QLQ-C30 scales. ResultsOf 31 patients, 28 completed the questionnaires. According to BPI evaluation, symptoms were improved in 57% of patients; the FACT-General (FACT-G) and liver function subscales revealed that there was symptom improvement in 89% and 7.1% of patients, respectively. Six items in the EORTC QLQ-C30 were improved. ConclusionsFollowing treatment, pain and clinical symptoms were improved in a considerable proportion of patients with pancreatic cancer, proving that palliative radiotherapy is feasible for pancreatic cancer.

Quality of Life and Sexual Functioning After Vulvar Reconstruction With the Lotus Petal Flap.

Resection of (pre) malignant lesions in the vulvoperineal area may result in large defects that cannot be closed primarily. The lotus petal flap technique is widely used for reconstruction. The aim of this study was to evaluate both quality of life (QoL) and sexual functioning of patients who underwent the lotus petal flap procedure, because no data are available on this topic. A cross-sectional study was performed on all eligible patients (N = 38) who underwent the lotus petal flap procedure between 2005 and 2016. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, Female Sexual Function Index, and Body Image Scale were used to evaluate QoL and sexual functioning. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Female Sexual Function Index scores were compared with scores of age-matched healthy women. Twenty-six patients (68%) responded. The mean (SD) age was 65.5 (16.3) years, and the median follow-up time was 38.5 months (range 16-141 months). Quality of life scores were lower compared with healthy women in the domains physical, role, and social functioning. Sexual activity rates were comparable with healthy women; however, sexual functioning was worse. Although patients were satisfied about their sexual life, pain was reported. Patients who underwent vulvar reconstructive surgery with lotus petal flaps seem to have a lower QoL compared with healthy women. Patients report more pain during sexual activity but are satisfied about their sexual functioning. These results should be included in preoperative counseling and follow-up of future patients eligible for vulvar reconstruction with a lotus petal flap.

Symptom Burden in Oral Cancer Patients During and Postcancer Treatment

Background: Oral cancer is one of the most common cancers seen in India which accounts for about 30% of all type cancers, with ranking as the top most among male. Due to advancements in diagnostic and treatment modalities, the survivorship of oral cancer patients has increased significantly during the last decade. Yet, the treatment of cancer accompanies symptom burden and psychosocial problems that impacts the quality of life of the patients. Aim: To assess the symptom burden among oral cancer patients during and post cancer treatment. Methods: A cross-sectional investigation was conducted to assess the symptom burden of 100 oral cancer patients (age range= 18-65 years, mean age=49.76) from a regional cancer institute (WIA), Chennai, India. Among them, 59 patients were under treatment and 41 had completed the treatment. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and QLQ-H &amp; N 35 module were used. The dependent t-test was used to compare two groups and Spearman correlation coefficients were used to assess the relationship between symptoms and demographic variables. Results: Significant difference was observed in the levels of pain and insomnia on symptoms scale of QLQ-C 30 between patients receiving and completed treatment ( P &lt; 0.05). Similarly, pain score on QLQ-HN 35 differed significantly between the patients on and after treatment ( P &lt; 0.05). In the QLQ-HN 35 module, dry mouth, opening mouth, sticky saliva, pain and tooth problems ranked as most worsening symptoms among oral cancer patients. However, in the QLQ-C 30, financial difficulties, fatigue and pain were ranked as the most worsening symptoms among oral cancer patients. Scores were significantly associated with a number of demographic variables such as age, gender, education, disease stage, time since diagnosis and treatment ( P &lt; 0.05). Conclusion: Oral cancer patients experience numerous worsening symptoms during as well as, posttreatment. This study emphasis the importance of assessing the symptom burden of the patients throughout the course of and completion of treatment as effective management could be implemented.

An exploratory study of social problems experienced by ambulatory cancer patients in Japan: Frequency and association with perceived need for help.

Little is known about the social problems experienced by cancer patients in non-Western countries. The aims of this study were (1) to explore the characteristics and frequencies of social problems in cancer outpatients, as well as their associations with the need for help, and (2) to take the initial steps to develop an instrument for the assessment of cancer-related social problems in Japan. A cross-sectional group of 109 patients completed the Social Problem Checklist and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. Participants rated the levels of the problem severity and the need for help on each item. Factor structure, internal consistency, and construct validity were also assessed. In total, 72.5% of the participants encountered ≥1 problem, and 33% experienced ≥1 serious problem. The amount of help needed tended to be lower than problem severity, especially for family and social life issues. The most common reason for not needing help, as reported by approximately 40% of patients who experienced problems, was the preference for self-management. A 3-factor model was extracted that included financial matters, medical information, and family and social life. Excellent internal consistencies for each factor and convergent correlations between the relevant subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Social Problem Checklist were confirmed. A substantial proportion of participants had cancer-related social problems, but they had ambivalent help-related needs. Interventions that enhance the patient's abilities for self-care could be essential to help cancer outpatients manage social problems in Japan.

Quality of life after esophageal resection.

IntroductionEsophageal resection is the primary treatment for malignant esophageal disease and the last resort for benign end-stage esophageal disease. There is a paucity of research comparing the long-term quality of life (QoL) following surgery among these two populations. The aim of this study was to examine the patient reported QoL after esophageal resection using questionnaires focusing on general well-being and esophageal-specific symptoms.MethodsA prospectively maintained database of post-operatively administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) with supplemental esophageal cancer-specific questionnaires (OES-18) was queried after institutional review board approval through Creighton University School of Medicine. Inclusions were made if patients received an esophageal resection for benign or malignant esophageal disease. Emergency procedures, delayed reconstructions, and stage IV disease were excluded. Student’s t-test was used for domains of function, symptoms, QoL, and esophageal-specific complaints to compare the groups with each other and with the general population.ResultsA total of 39 out of 248 patients with malignant disease and 24 out of 46 with benign disease completed the questionnaire. A mean post-operative follow-up of 53 months with a response rate of 40% was obtained. There was no difference in physical (p=0.81), role (p =0.37), conditional (p=0.73), emotional (p=0.06), or social functions (p=0.42) between the general population and the esophageal resection groups. There was also no significant difference in generalized pain (p=0.86), nausea/vomiting (p=0.27), fatigue (p=0.86), swallowing (p=0.35), or esophageal pain (p=0.12). The malignant cohort had better outcomes than the benign cohort with respect to eating (p=0.04), indigestion (p=0.04), and QoL (p=<0.01).DiscussionThe underlying disease between these cohorts is drastically different, but postoperative functional status, generalized symptoms, swallowing ability, and esophageal pain were similar. There was no difference in functional status between the general population and the esophageal resection cohorts. Patients with malignant disease reported less problems with eating and a better QoL than their benign counterparts.

Efficacy of Mobile Health Care Application and Wearable Device in Improvement of Physical Performance in Colorectal Cancer Patients Undergoing Chemotherapy

BackgroundThe use of a mobile health care application, the delivery of health care or health care-related services through the use of portable devices, to manage functional loss, treatment-related toxicities, and impaired quality of life in cancer patients during chemotherapy through supervised self-management has been increasing. The aim of the present study was to evaluate the efficacy and feasibility of comprehensive mobile health care using a tailored rehabilitation program for colorectal cancer patients undergoing active chemotherapy. Patients and MethodsA total of 102 colorectal cancer patients undergoing chemotherapy underwent 12 weeks of smartphone aftercare through provision of a mobile application and wearable device that included a rehabilitation exercise program and information on their disease and treatment. The grip strength test, 30-second chair stand test, 2-minute walk test, amount of physical activity (International Physical Activity Questionnaire short-form), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30), and nutritional status (Patient-generated Subjective Global Assessment) were assessed and measured at baseline, at mid-intervention (6 weeks), and at completion of the intervention (12 weeks). The rehabilitation exercise intensity was adjusted by the test results at every assessment and through real-time communication between the patients and clinicians. ResultsOf the 102 patients, 75 completed all 12 weeks of the smartphone aftercare rehabilitation program. The lower extremity strength (P < .001) and cardiorespiratory endurance (P < .001) was significantly improved. Fatigue (P < .007) and nausea/vomiting (P < .040) symptoms were significantly relieved after the program. ConclusionA tailored rehabilitation exercise program provided through a comprehensive mobile health care application was effective in improving patients' physical capacity and treatment-related symptoms even during active chemotherapy.

Changes in upper extremity function, ADL, and HRQoL in colorectal cancer patients after the first chemotherapy cycle with oxaliplatin: a prospective single-center observational study

PurposeOxaliplatin, an important chemotherapeutic agent in colorectal cancer, causes chemotherapy-induced peripheral neuropathy (CIPN), for which prophylactic or therapeutic interventions are lacking. We aimed to investigate changes in upper extremities, activities of daily living (ADL), and health-related quality of life (HRQoL) parameters after the first chemotherapy cycle.MethodsThirty-eight colorectal cancer patients scheduled to receive the leucovorin, 5′-fluorouracil, oxaliplatin (FOLFOX) therapy or the capecitabine, oxaliplatin (CAPOX) therapy, participated. Patients underwent objective assessment of sensory function, muscular strength, and manual dexterity and answered the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the Disabilities of the Arm, Shoulder, and Hand-Disability/Symptom (DASH-DS) questionnaires for subjective assessment. The CIPN was assessed at baseline and prior to the second drug cycle.ResultsLight touch sensation in both hands worsened significantly after the first drug cycle, though no significant changes were observed in muscular strength and manual dexterity. The QLQ-C30 analysis showed that Physical Functioning, Role Functioning, Nausea and Vomiting, and Dyspnea were significantly worse, whereas Emotional Functioning was improved. The DASH-DS analysis revealed significant worsening of dysfunction and subjective symptoms.ConclusionsOur results suggest that light touch sensation may worsen even in the absence of multiple chemotherapy cycles. Even if arm and hand function (muscular strength and manual dexterity) is apparently intact, patients may experience dysfunction and decreased HRQoL. For preserving or improving patients’ ADL and HRQoL, it is imperative to provide support at chemotherapy initiation.

Assessment of quality of life in resectable gastric cancer patients undergoing chemoradiotherapy as adjuvant treatment.

Introduction:Quality of life (QOL) is increasingly recognized as an important endpoint in cancer therapies. However, few data are available on QOL in patients who have received radiotherapy as adjuvant treatment for cancer stomach.Methods:Thirty patients who underwent curative resection were enrolled and received chemoradiotherapy (45 Gy in 25 fractions using three-dimensional conformal radiotherapy technique), together with 5-fluorouracil and leucovorin. The European Organization for Research and Treatment of Cancer QOL questionnaire C30 and STO Q22 was assessed at four time points: pre- and postchemoradiotherapy and at 1-month and 6-month follow-up.Results:Mean age of the patients was 54 years. Male:female ratio was 4:1. Stage II and Stage III disease was present in 60% and 30% of patients, respectively. All patients were able to complete the chemoradiotherapy protocol. Our study found out significant impairment in QOL for emotional functioning, fatigue, nausea and vomiting and dyspnea. Results showed that QOL levels decrease postchemoradiotherapy; however, QOL levels returned to baseline at 1-month and 6-month follow-up period.Conclusion:Chemoradiotherapy as adjuvant treatment for cancer stomach patients who have undergone resection with curative intent is a safe and well-tolerated regimen with respect to QOL.

Benefit or Harm? A Study on Impact of Collusion on the Quality of Life among Palliative Care Patients.

Background:In India, roughly one-half of patients undergoing cancer treatment are unaware of their diagnosis or treatment. The intention of this study is to determine the prevalence of collusion and its influence on quality of life (QOL) among patients in palliative care settings.Methodology:A cross-sectional study was conducted among 100 palliative care patients to assess the extent of knowledge about their diagnosis and prognosis. The caretakers and the treating doctors were interviewed using a semi-structured questionnaire to assess if diagnosis was revealed to a patient. QOL of the patients was assessed using the European Organisation for Research and Treatment of Cancer QOL Questionnaire-C30 questionnaire.Results:The prevalence of collusion was 37%, i.e., in more than one-third of the palliative care patients; caregivers restrained doctors from disclosing the diagnosis. The prevalence of collusion was less among patients with higher educational qualification (P = 0.027) and professionals (P = 0.025). Collusion was not associated with gender, type of family, place of residence, and socioeconomic status (SES). In multivariate regression, collusion (odds ratio = 10.53) was independently associated with poor QOL when adjusted for age, gender, place of residence, religion, educational status, family type, and SES.Conclusion:Collusion is fairly prevalent and it worsens the QOL among cancer patients. Since the main driver for collusion is the strong desire among caregivers to protect the physical and psychological well-being, the findings of the study could motivate the caregiver for a more open and honest communication.

Potential curability and perception of received information in esophageal cancer patients.

This study aimed to evaluate patients' perceived receipt of information according to the possibility of cure in esophageal cancer. One hundred and twelve consecutive patients presenting at the multidisciplinary visit at the Veneto Institute of Oncology for esophageal cancer between 2014 and 2016 were included in the study. The Italian version of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires C30 (core questionnaire), OG25 (esophago-gastric cancer module), and INFO25 (information module) were used. Candidates for palliative treatment were less informed about the disease (adjusted mean difference - 11.5, 95% CI - 23.0 to - 0.02) and less satisfied with information provided (adjusted mean difference - 18.3, 95% CI - 31.9 to - 4.7) than candidates for curative treatment. In addition, candidates for palliative treatment wanted to receive more information than candidates for curative treatment (adjusted mean difference 26.1, 95% CI 0.5 to 51.6). Better quality of life was associated with satisfaction of received information (β = 0.77, p < 0.0001) and of receiving information about things that the patient can do to help himself (β = 0.26, p = 0.04). More anxiety was associated to receiving more information about disease (β = 0.46, p = 0.02) but less information about things that the patient can do to help himself (β = - 0.38, p = 0.02). Candidates for palliative treatment were less satisfied with information about the disease and wanted to receive more information. Additionally, some aspects of quality of life were found to be associated with perceived receipt of information. Appropriate training in communication of prognostic information may improve clinical management of incurable cancer patients.

Impact of dose intensified salvage radiation therapy on urinary continence recovery after radical prostatectomy: Results of the randomized trial SAKK 09/10

IntroductionAdjuvant radiation therapy (aRT) after radical prostatectomy (RP) is associated with impaired urinary continence recovery as compared to surveillance. Less is known regarding the effect of salvage radiation therapy (sRT) dose intensification on continence outcomes. Materials and methodsUrinary continence recovery was investigated within a multicentre randomized trial in biochemically recurrent prostate cancer patients who received either 64 Gy (32 fractions) or 70 Gy (35 fractions) sRT. Incontinence was assessed using Common Toxicity Criteria for Adverse Events v4.0 at baseline, at the end of sRT and 3 months afterward. Quality of life (QoL) was assessed with the EORTC QoL questionnaires C30 and PR25 at baseline and 3 months after completion of sRT. A total of 344 patients were evaluable. ResultsAt baseline 233 (68%) of patients were fully continent and 14% in both arms became incontinent three months after treatment. Of the remaining 111 (32%) patients being incontinent at baseline, continence recovery was achieved 3 months after sRT by 44% vs. 41% with 64 vs. 70 Gy, respectively (p = 0.8). This analysis is limited by its short follow-up. ConclusionsDose intensification of sRT had no impact on early urinary continence recovery or prevalence of de novo incontinence.

Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma

ObjectiveReport results of patient-reported health-related quality of life (HRQoL) and symptoms from phase III KEYNOTE-006 study of pembrolizumab versus ipilimumab in patients with ipilimumab-naive advanced melanoma. Patients and methodsPatients received pembrolizumab 10 mg/kg every 2 (Q2W) or every 3 weeks (Q3W) for up to 2 years, or four cycles of ipilimumab 3 mg/kg Q3W. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was administered at baseline and throughout the study. Patient-reported outcome (PRO) analyses were pre-specified exploratory endpoints; the primary PRO assessment was the score change from baseline to week 12 in EORTC QLQ-C30 global health status (GHS)/HRQoL score between the arms using constrained longitudinal data analysis. ResultsThe PRO analysis population included 776 patients: pembrolizumab Q2W (n = 270); pembrolizumab Q3W (n = 266); ipilimumab (n = 240). Baseline GHS was similar across arms. QLQ-C30 compliance rates at week 12 were 87% (n = 214), 97% (n = 226), and 96% (n = 178), for the pembrolizumab Q2W, pembrolizumab Q3W, and ipilimumab arms, respectively. From baseline to week 12, GHS/HRQoL scores were better maintained with pembrolizumab than with ipilimumab (decrease of −1.9 and −2.5 for pembrolizumab versus −10.0 for ipilimumab; p < 0.001 for each pembrolizumab arm versus ipilimumab). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31% for pembrolizumab Q2W; 29% for Q3W and 44% for ipilimumab), with similar trends observed for individual functioning and symptoms scales. ConclusionsHRQoL was better maintained with pembrolizumab than with ipilimumab in patients with ipilimumab-naive advanced melanoma. ClinicalTrials.gov identifierNCT01866319.

Effects of a complex rehabilitation program on edema status, physical function, and quality of life in lower-limb lymphedema after gynecological cancer surgery.

The purpose of this study was to investigate the effects of a complex rehabilitation (CR) program and complex decongestive therapy (CDT) on edema status, physical function, and quality of life in patients with unilateral lower-limb lymphedema after gynecologic cancer surgery. In this randomized pilot study, 40 patients with secondary unilateral lymphedema, after gynecologic surgery for cervical, endometrial, or ovarian cancer, that had been diagnosed based on clinical assessment and 10% volume differences between the legs were randomly assigned to the CDT (n=20) and CDT combined with CR (CRCDT; n=20) groups. CR comprised stretching, strengthening, and aerobic exercises performed for 40min, five times a week for 4weeks. Intensive CDT was administered by a physical therapist during weeks 0-2 and by the patients themselves during weeks 2-4. Limb volume, bioimpedance, muscular strength, EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30) score, 30-s chair stand test, muscular strength, and GCLQ-K (Korean version of the Gynecological Cancer Lymphedema Questionnaire) score were assessed at baseline and after 4weeks of treatment. The edema status, fatigue, pain, and GCLQ-K scores were significantly improved in both groups after the 4-week intervention (P<0.05). Physical function and fatigue in EORTC QLQ-C30 and the 30-s chair stand test and quadriceps muscle strength were significantly improved in the CRCDT group compared with the CDT group (P<0.05). CR improves physical function, fatigue, and muscular strength without increasing edema status in patients with unilateral lower-limb lymphedema after gynecologic cancer surgery.

Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods

ObjectivesHolistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional...