Cancer Quality Of Life Questionnaire-C30 Research Articles

Oncologic results and quality of life in patients with T3 glottic cancer after transoral laser microsurgery

CO2 transoral laser microsurgery (CO2 TOLMS) is an alternative approach to non-surgical organ preservation in selected T3 glottic squamous cell carcinoma (SCC). This study aimed to assess the oncologic results and quality of life (QOL) of patients with T3 glottic SCC after CO2 TOLMS. Of the 44 patients who underwent CO2 TOLMS, 38 underwent QOL evaluations. QOL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and head and neck module, Voice Handicap Index-30, and M. D. Anderson Dysphagia Inventory at least 6months postoperatively. The patients were predominantly male (98%), with a median age of 61years. Cordectomy type included 1 type III, 4 type IV, 31 type V, and 8 type VI according to European Laryngological Society classification. Two patients (5%) had cervical lymph node metastasis and 21 patients (48%) underwent postoperative radiotherapy. With a mean follow-up of 65months for all patients, 10 (23%) had tumor recurrence (9 local, 1 distant). After salvage surgery, four patients lived without disease, and the larynx was preserved in two. The 5-year local control and overall and disease-specific survival rates were 78%, 75%, and 84%, respectively. The overall laryngeal preservation rate was 82% (36/44). Most patients had satisfactory QOL. In selected T3 glottic SCC cases, CO2 TOLMS can achieve favorable oncologic results and a satisfactory QOL.

Impact of low anterior resection syndrome (LARS) on the quality of life and treatment options of LARS - A cross sectional study.

The purpose of this study was to assess the relationship between the low anterior resection syndrome (LARS) and quality of life (QOL). Furthermore, in patients with major LARS, therapeutic management options were explored. A cohort of surviving patients, who underwent a low anterior resection for rectal cancer after long course of radiochemotherapy, were identified. These patients were treated in Ghent University Hospital between 2006 and 2016. QOL was assessed using the European Organization for Research and Treatment of Cancer Quality Of Life questionnaire-C30 and the bowel function using the LARS-score. The relationship between LARS and QOL was analysed. Patients with major LARS (≥30 points) were contacted to explore their therapeutic management of LARS. 69% of the participants had major LARS. QOL was closely associated with LARS. Significant differences were found between those with and without LARS in the global health status (p≤0.001) and in the following functional scales: physical (p≤0.001), role (p≤0.001), cognitive (p=0.04) and social (p≤0.001). Patients with major LARS experienced more diarrhea (p≤0.001), fatigue (p=0.002), insomnia (p≤0.001) and pain (p=0.02), compared to patient with no/minor LARS. Most patients tried dietary regimens (71%), medication (71%) and incontinence material (63.8%) in an attempt to manage their LARS and found some of them useful. The level of the anastomosis (low) was a significant risk factor for major LARS (p=0.03). More than half of the patients in this cohort still suffered from major LARS. Patients confronted with major LARS had a lower QOL than patients with no/minor LARS. Currently, there is no gold standard for the management of LARS. Patients manage it through trial and error.

Supplemental home parenteral nutrition improved nutrition status with comparable quality of life in malnourished unresectable/metastatic gastric cancer receiving salvage chemotherapy.

Even with significant advances in surgical techniques and treatment, salvage chemotherapy remains the major treatment strategy for patients with unresectable or metastatic gastric cancer (GC). Practical and technical advances have simplified safe and convenient use of supplemental home parenteral nutrition (HPN). We aimed to clarify the role of HPN in patients with incurable GC undergoing salvage chemotherapy. We enrolled 25 patients with GC with a nutritional risk index (NRI) of ≦ 97.5 undergoing HPN. Their nutritional status, laboratory data, and quality of life (QoL) were analyzed using the Research and Treatment of Cancer quality of life questionnaire-C30 before and after HPN administration at 0.5, 1, 2, and 3 months. We enrolled 25 patients with an NRI of > 97.5 not undergoing HPN as the control group. Total protein (P = 0.008), prealbumin (P < 0.001), and total cholesterol (P = 0.023) levels improved significantly after 0.5 months of HPN administration. The study group also demonstrated a marked improvement in nitrogen balance (P = 0.004) and prealbumin levels (P < 0.012) after 1 month. Gains in body weight after 1 month and body mass index after 2 months of HPN administration remained comparable with those of the control group. Global QoL scores were maintained and comparable with those of the control group. Supplemental HPN therapy for malnourished patients with unresectable or metastatic GC undergoing salvage chemotherapy is feasible and revealed marked improvement in nutritional status. Early HPN intervention should be considered an important part of palliative treatment for advanced GC.

Quality of life in patients with gastroenteropancreatic tumours: A systematic literature review.

BACKGROUNDGastroenteropancreatic neuroendocrine tumours (GEP-NETs) are slow-growing cancers that arise from diffuse endocrine cells in the gastrointestinal tract (GI-NETs) or the pancreas (P-NETs). They are relatively uncommon, accounting for 2% of all gastrointestinal malignancies. The usual treatment options in advanced GEP-NET patients with metastatic disease include chemotherapy, biological therapies, and peptide receptor radionuclide therapy. Understanding the impact of treatment on GEP-NET patients is paramount given the nature of the disease. Health-related quality of life (HRQoL) is increasingly important as a concept reflecting the patients’ perspective in conjunction with the disease presentation, severity and treatment.AIMTo conduct a systematic literature review to identify literature reporting HRQoL data in patients with GEP-NETs between January 1985 and November 2019.METHODSThe PRISMA guiding principles were applied. MEDLINE, Embase and the Cochrane library were searched. Data extracted from the publications included type of study, patient population data (mid-gut/hind-gut/GI-NET/P-NET), sample size, intervention/comparators, HRQoL instruments, average and data spread of overall and sub-scores, and follow-up time for data collection.RESULTSForty-three publications met the inclusion criteria. The heterogeneous nature of the different study populations was evident; the percentage of female participants ranged between 30%-60%, whilst average age ranged from 53.8 to 67.0 years. Eight studies investigated GI-NET patients only, six studies focused exclusively on P-NET patients and the remaining studies involved both patient populations or did not report the location of the primary tumour. The most commonly used instrument was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (n = 28) with consistent results across studies; the GI-NET-specific module Quality of Life Questionnaire-GINET21 was used in six of these studies. A number of randomised trials demonstrated no HRQoL changes between active treatment and placebo arms. The Phase III NETTER-1 study provides the best data available for advanced GEP-NET patients; it shows that peptide receptor radionuclide therapy can significantly improve GEP-NET patients’ HRQoL.CONCLUSIONHRQoL instruments offer a means to monitor patients’ general disease condition, disease progression and their physical and mental well-being. Instruments including the commonly used European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and GINET21 lack, however, validation and a defined minimal clinical important difference specifically for GI-NET and P-NET patients.

Severe symptoms and very low quality-of-life among outpatients newly diagnosed with advanced cancer: data from a multicenter cohort study

PurposeThe aim of this study was to identify symptoms of severe intensity or very low scores for quality of life (QoL) domains in newly diagnosed outpatients with advanced cancer.MethodsThis multicenter cohort study from a state-wide palliative care network included adult outpatients with advanced cancer diagnosed within the preceding 8 weeks from four comprehensive cancer centers (DRKS00006162, registered on 19 May 2014). We used the Palliative Outcome Scale (POS), Hospital Anxiety and Depression Scale, and European Organization for Research and Treatment of Cancer QoL Questionnaire-C30. For each questionnaire, cut-off scores defined symptoms and QoL domains that were considered “severe” or “very low.”ResultsOf 3155 patients screened, 481/592 (81.3%) were analyzed (mean age 62.4; women n = 245, 50.9%). We identified 324/481 (67.4%) patients experiencing at least one severe symptom or a very low QoL domain (median 2; range 0 to 16). Role functioning (n = 180, 37.4%), fatigue (n = 162, 33.7%), and social functioning (n = 126, 26.2%) were most commonly affected. QoL was very low in 89 patients (18.5%). Women experienced more anxiety symptoms, fatigue, and had lower POS scores. Patients often mentioned physical symptoms and fears of adverse events resulting from disease-modifying therapies (e.g., chemotherapy) as most relevant problems.ConclusionsAlready within the first 8 weeks after diagnosis, the majority of patients reported at least one severe symptom or a very low QoL domain. Gender differences were evident. The findings illustrate the value of early routine assessment of patient burden and the development of multi-professional and interdisciplinary palliative care.

Factors associated with the quality of life for hospitalized patients with HPV-associated oropharyngeal squamous cell carcinoma.

Oropharynx squamous cell cancer (OPSCC) is a type of head and neck squamous cell carcinoma. The raising OPSCC incidence is mainly attributed to human papillomavirus (HPV). HPV-related OPSCC has a relatively good prognosis, the concerns are focused on the improvement of quality-of-life (QOL). We aimed to figure out the factors which may affect the QOL of HPV-related OPSCC patients after treatment. This study included patients with HPV-related OPSCC. The QOL of the patients were analyzed through the administration of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)-Chinese version, the European Organization for Research and Treatment of Cancer Head and Neck Cancer Module-35 (EORTC QLQ-H&N-35)-Chinese version, and Eating Assessment Tool-10 (EAT-10). Multivariable regression analysis was employed to detect the influence of predictor variables on the QOL of patients. A total of 294 HPV-related OPSCC patients were involved in this research. The results of EORTC QLQ-C30, EORTC QLQ-H&N-35, and EAT-10 demonstrated that the treatment decreased the QOL of HPV-related OPSCC patients. Several different factors including marital status, consumption of tobacco and alcohol, tumor sites, clinical stages, therapeutic strategies, and neck dissection were proved to have influence on QOL of HPV-related OPSCC after treatment. Based on the analyzation of the QOL at baseline and after treatment, we demonstrated several factors which influenced the QOL of HPV-associated OPSCC patients after treatment. These results can make a great contribution to the improvement of the QOL after treatment.

The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in patients with coloreactal cancer: study protocol for a single-blinded, randomized sham-controlled trial

BackgroundColorectal cancer is the most common cancer in Hong Kong. Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese medicine. This study aims to examine the efficacy and safety of acupuncture for alleviating CIPN in patients with colorectal cancer in Hong Kong.Methods/designThis is a single-blinded, randomized, sham-controlled efficacy trial. Eighty-four eligible patients, who are Hong Kong Chinese, aged ≥ 18 years, diagnosed with colorectal cancer and undergoing oxaliplatin-based chemotherapy, will be randomized in a ratio of 1:1 to the electro-acupuncture group or the sham-controlled group. During a 12-week treatment period, patients in the electro-acupuncture group will undergo electro-acupuncture once a week from the first cycle of chemotherapy, while patients in the control group will receive sham acupuncture, and the patients in both groups will be followed up for 12 weeks. The primary outcome measure is the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire. The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ).DiscussionThe study will compare electro-acupuncture with sham acupuncture to explore the feasibility for electro-acupuncture in improving symptoms caused by chemotherapy-induced peripheral neuropathy.Trial registrationClinicaltrials.gov, NCT03582423. Registered on 11 July 2018.

Cross-cultural adaptation and validation of the cancer survivors’ unmet needs measure among gynecological cancer patients in Indonesia

Background: The number of gynecological cancer survivors in Indonesia is growing, yet little is recognized about their supportive care needs due to a lack of validated assessment to measure them. This study aimed to culturally adapt the Cancer survivors? unmet needs into Indonesian language and to test its validity and reliability for Indonesian gynecological cancer patients. Methods: We performed the translation and adaptation of the Cancer survivors? unmet needs based on Beaton?s cross-cultural adaptation process of self-report measure. We then evaluated the psychometric properties of Cancer survivors? unmet needs -Indonesian with 298 participants from three hospitals across Indonesia. Results: Five factors were extracted from Exploratory Factor Analysis with factor loading &gt;0.4. Cancer survivors? unmet needs - Indonesian had negative correlations with The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, indicating that the higher score of unmet needs resulted in the lower score of quality of life. The Cronbach?s ? coefficient for the Cancer survivors? unmet needs - Indonesian ranged from 0.75-0.95. Conclusions: The Cancer survivors? unmet needs - Indonesian version offers a valid and reliable scale for assessing supportive care needs among Indonesian gynecological cancer patients. The Cancer survivors? unmet needs-Indonesian could help clinicians to assess supportive care needs among Indonesian gynecological cancer patients. The low-resource countries such as Indonesia could use the evidence from the Cancer survivors? unmet needs assessment to develop the supportive care service in the clinical settings.

The relationship between the BMI-adjusted weight loss grading system and quality of life in patients with incurable cancer.

BackgroundWeight loss (WL) has long been recognized as an important factor associated with reduced quality of life (QoL) and reduced survival in patients with cancer. The body mass index (BMI)‐adjusted weight loss grading system (WLGS) has been shown to be associated with reduced survival. However, its impact on QoL has not been established. The aim of this study was to assess the relationship between this WLGS and QoL in patients with advanced cancer.MethodsA biobank analysis was undertaken of adult patients with advanced cancer. Data collected included patient demographics, Eastern Cooperative Oncology Group performance status, and anthropometric parameters (BMI and %WL). Patients were categorized according to the BMI‐adjusted WLGS into one of five distinct WL grades (grades 0–4). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire‐C30. The Kruskal–Wallis test and multivariate logistic regression analyses were used to assess the relationship between the WLGS and QoL scores. Overall survival was assessed using Kaplan–Meier curve and Cox proportional hazard models.ResultsA total of 1027 patients were assessed (51% male, median age: 66 years). Gastrointestinal cancer was most prevalent (40%), and 87% of patients had metastatic disease. Half (58%) of patients had a WL grade of 0–1, while 12%, 20%, and 10% had WL grades of 2, 3, and 4, respectively. Increasing WL grades were significantly associated with poorer QoL functioning and symptoms scales (all P < 0.05). Physical, role, and emotional functioning decreased by a median of >20 points between WL grade 0 and WL grade 4, while appetite loss, pain, dyspnoea, and fatigue increased by a median score >20 points, indicative of a large clinical significant difference. Increasing WL grades were associated with deteriorating QoL summary score. WL grades 2, 3, and 4 were independently associated with a QoL summary score below the median (<77.7) [odds ratio (OR) 1.69, P = 0.034; OR 2.06, P = 0.001; OR 4.29, P < 0.001, respectively]. WL grades 3 and 4 were independently associated with reduced overall survival [hazard ratio 1.54 (95% confidence interval: 1.22–1.93), P < 0.001 and hazard ratio 1.87 (95% confidence interval: 1.42–2.45), P < 0.001, respectively].ConclusionsOur findings support that the WLGS is useful in identifying patients at risk of poor QoL that deteriorates with increasing WL grades. WL grade 4 is independently associated with a particularly worse prognosis and increased symptom burden. Identification and early referral to palliative care services may benefit these patients.

1621P - Health-related quality of life of advanced melanoma survivors treated with CTLA-4 immune checkpoint inhibition: A matched cohort study

BackgroundSince the introduction of immune-checkpoint blockade, the overall survival has significantly improved for patients with advanced melanoma. However, to date, there is limited data on patients’ functioning and health-related quality of life (HRQoL), years after active treatment. Therefore, we evaluated these outcomes in advanced melanoma survivors (AMS) and compared these with matched controls. MethodsIpilimumab-treated AMS without systemic treatment for at least 2 years were recruited from 15 hospitals. The primary outcome was HRQoL assessed with the European Organization for Research and Treatment of Cancer quality of life questionnaire-C30 (QLQ-C30). Secondary outcomes were fatigue, anxiety, depression and disease specific HRQoL. Up to 5 controls per AMS were individually matched on age, gender and educational status. Survivors and controls were compared on QLQ-C30 scores using generalized estimating equations. Differences in QLQ-C30 scores were classified as clinically important according to published guidelines. ResultsA total of 89 AMS were evaluated in this study. After last administration of ipilimumab, the mean follow-up (FU) was 45.5 (SD 20.8) months. Comparison with matched controls showed that AMS scored significantly lower on physical (difference (diff) = -5.80, p=.005), role (diff =-5.97, p=.02), cognitive (diff = -8.05, p=.001), and social functioning (diff = -8.49, p=<.001) and higher in symptom burden of fatigue (diff =7.48, p=.004), dyspnea (diff = 6.47, p=.02), diarrhea (diff = 3.78, p=.04) and financial impact (diff = 8.07, p=.001). Comparison between AMS with a FU≥36 and FU<36 months showed that social functioning, global QoL and financial impact scores were higher among the longer term survivors. Group differences in both analyses were clinically relevant. ConclusionsCompared to matched controls, AMS showed overall worse functioning scores and more symptoms of fatigue, dyspnea, diarrhea and financial impact. AMS with a longer FU reported better QoL, but more financial issues. These study results may help to develop interventions to the individual healthcare needs of AMS and contribute to the development of appropriate survivorship care. Legal entity responsible for the studyNetherlands Cancer Institute. FundingBristol-Myers Squibb. DisclosureAll authors have declared no conflicts of interest.

CT- and MRI-Based Assessment of Body Composition and Pancreatic Fibrosis Reveals High Incidence of Clinically Significant Metabolic Changes That Affect the Quality of Life and Treatment Outcomes of Patients with Chronic Pancreatitis and Pancreatic Cancer.

Background and Objectives: Both chronic pancreatitis (CP) and pancreatic ductal adenocarcinoma (PDAC) may lead to cachexia, sarcopenia, and osteoporosis due to different mechanisms. Neither patient gender, age, nor body weight are good predictors of these metabolic changes having a significant negative impact on the quality of life (QOL) and treatment outcomes. The aim of this study was to evaluate radiological changes in body composition and to compare them with manifestations of exocrine and endocrine pancreatic insufficiency, body mass, and QOL among patients with CP and PDAC. Materials and Methods: Prospectively collected data of 100 patients with diagnosed CP or PDAC were used for analysis. All patients underwent dual-energy X-ray absorptiometry (DXA), computed tomography (CT), and magnetic resonance imaging (MRI). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) was used to assess QOL. Diabetes and changes in fecal elastase-1 were also assessed. Results: There was no significant difference in skeletal muscle mass (SMM) among patients with CP and PDAC (p = 0.85). Significantly more underweight patients had low SMM (p = 0.002). Patients with CP had more pronounced pancreatic fibrosis (PF) (p < 0.001). Data showed a significant relationship between a high degree of PF and occurrence of diabetes (p = 0.006) and low fecal elastase-1 levels (p = 0.013). A statistically significant lower QOL was determined in patients with PF ≥ 50% and in the CP group. Conclusions: Sarcopenia and osteoporosis/osteopenia are highly prevalent among patients with chronic pancreatitis and pancreatic cancer, and CT- and MRI-based assessment of body composition and pancreatic fibrosis could be a potentially useful tool for routine detection of these significant metabolic changes.

A Prospective Single-Arm Phase 2 Study of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy for Prostate Cancer: Early Toxicity Results

Use of stereotactic body radiation therapy (SBRT) is increasing in patients with localized prostate cancer, but concerns about early and late gastrointestinal (GI) and genitourinary (GU) toxicity exist after moderately or extremely hypofractionated radiation therapy schemes. Magnetic resonance guided radiation therapy (MRgRT) was clinically introduced in 2014. MrgRT allows for SBRT delivery with smaller uncertainty margins and permits daily adaptive planning. A phase 2 study in patients with localized prostate cancer was performed to study early GI and GU toxicity after SBRT using MRgRT. One hundred one patients with clinical stage T1-3bN0M0 prostate cancer were enrolled in this prospective phase 2 study. All but 4 patients had intermediate- or high-risk prostate cancer, and 82.2% received adjuvant hormonal treatment. MRgRT was delivered in 5 fractions of 7.25 Gy to the target volume using daily plan adaptation with simultaneous relative sparing of the urethra to a dose of 6.5 Gy per fraction. Early toxicity was studied using both clinician- (Common Terminology Criteria for Adverse Events and Radiation Therapy Oncology Group) and patient-reported outcome measurements (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, Quality of Life Questionnaire PR25, and International Prostate Symptom Scoring). The maximum cumulative grade ≥2 early GU and GI toxicity measured by any symptom at any study time point was 23.8% and 5.0%, respectively. No early grade 3 GI toxicity was observed. Early grade 3 GU toxicity was 0% and 5.9% according to the Common Terminology Criteria for Adverse Events and Radiation Therapy Oncology Group and scoring systems, respectively, as a result of different grading of radiation cystitis. The low incidence of early GI toxicity was confirmed by patient-reported outcome data. GU grade ≥2 toxicity peaked to 19.8% at the end of MRgRT, followed by a return to the baseline average score at 3-month follow-up. This prospective study of MRgRT in patients with localized prostate cancer observed a low incidence of early GI and GU toxicity, both in clinician- and patient-reported outcome measurements.

Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial

ABSTRACTBackgroundCurcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.ObjectivesThis phase IIa open-labelled randomized controlled trial aimed to assess safety, efficacy, quality of life, neurotoxicity, curcuminoids, and C-X-C-motif chemokine ligand 1 (CXCL1) in patients receiving folinic acid/5-fluorouracil/oxaliplatin chemotherapy (FOLFOX) compared with FOLFOX + 2 g oral curcumin/d (CUFOX).MethodsTwenty-eight patients aged >18 y with a histological diagnosis of metastatic colorectal cancer were randomly assigned (1:2) to receive either FOLFOX or CUFOX. Safety was assessed by Common Toxicity Criteria-Adverse Event reporting, and efficacy via progression-free survival (PFS) and overall survival (OS). Quality of life and neurotoxicity were assessed using questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Functional Assessment of Cancer Treatment-Gynecologic Oncology Group-Neurotoxicity). Plasma curcuminoids were determined with liquid chromatography (LC) electrospray ionization tandem mass spectrometry and CXCL1 by ELISA.ResultsAddition of daily oral curcumin to FOLFOX chemotherapy was safe and tolerable (primary outcome). Similar adverse event profiles were observed for both arms. In the intention-to-treat population, the HR for PFS was 0.57 (95% CI: 0.24, 1.36; P = 0.2) (median of 171 and 291 d for FOLFOX and CUFOX, respectively) and for OS was 0.34 (95% CI: 0.14, 0.82; P = 0.02) (median of 200 and 502 d for FOLFOX and CUFOX, respectively). There was no significant difference between arms for quality of life (P = 0.248) or neurotoxicity (P = 0.223). Curcumin glucuronide was detectable at concentrations >1.00 pmol/mL in 15 of 18 patients receiving CUFOX. Curcumin did not significantly alter CXCL1 over time (P = 0.712).ConclusionCurcumin is a safe and tolerable adjunct to FOLFOX chemotherapy in patients with metastatic colorectal cancer. This trial was registered at clinicaltrials.gov as NCT01490996 and at www.clinicaltrialsregister.eu as EudraCT 2011-002289-19.

Patient-reported outcomes of patients treated with (neo)adjuvant immune checkpoint combination therapy in high-risk stage III macroscopic melanoma: A matched cohort study.

9588 Background: Results from the phase 1b (OpACIN) study comparing neoadjuvant to adjuvant ipilimumab (3mg/kg) plus nivolumab (1mg/kg) demonstrated a high clinical activity of neoadjuvant treatment in high-risk melanoma. However, the toxicity was high, with 90% grade 3 to 4 toxicity. These findings raise questions about long-term quality of life (QoL) in these patients (pts) who were treated with curative intent. Here we present the first analysis of patient-reported outcomes of patients treated with (neo)adjuvant immune checkpoint combination therapy. Methods: Sixteen of 20 pts had completed study treatment and were currently in follow-up (FU). Pts were asked to fill in The European Organisation for Research and Treatment of Cancer QoL questionnaire-C30 (QLQ-C30). The QLQ-C30 was used to assess health-related QoL and is composed of functional, symptomatic dimensions and a dimension of global health/QoL. A reference population (controls without a diagnosis of cancer) was obtained from the ‘Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship’ registry. Pts were individually matched on age, gender, education and marital status with up to 9 controls. Pts and controls were compared on QLQ-30 scores using univariable linear regression analyses. Results: Thirteen out of 16 invited pts (81% response) returned a completed questionnaire. Median FU was 30 months after randomization. Pts scored significantly lower in emotional (std coeff. = -1.0, p = .007), role (std coeff. = -0.7, p = .08), cognitive (std coeff. = -0.8, p = .018) and social (std coeff. = -1.0, p = .014) functioning and higher in symptom burden of fatigue (std coeff. = .9, p = .024) compared to controls, which were all clinically relevant. The physical functioning and global QoL score did not differ between pts and controls. Conclusions: High risk stage III melanoma pts treated with (neo)adjuvant immune checkpoint combination therapy showed significantly lower emotional, role, cognitive and social functioning scores than controls. Pts reported higher levels of fatigue, however, there was no difference on physical functioning and global QoL between pts and controls.

Affective Psychopathology Towards the Quality of Life of Breast Cancer Patients with Radiotherapy in Medan, Indonesia.

BACKGROUND:Cancer has to become the scariest disease and tends to reduce the quality of life of the patient. Therefore, it is not only a medical treatment that needs to be conducted but also a psychological treatment.AIM:to analyse the relationship between affective psychopathology and the quality of life of breast cancer patients who are receiving radiotherapy treatment.METHODS:This research was a correlative analytical study with a cross-sectional approach using the Hospital Anxiety and Depression Scale (HADS) instrument to assess psychopathological features and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) to determine the quality of life. This research was conducted in March 2016-July 2016 at Vina Estetika Cancer Center Hospital, Medan, Indonesia. As many as 47 subjects were divided into two criteria; Inclusion criteria, participants with breast cancer who were undergoing radiotherapy, aged over 18 years, with HADS score ≥ 17, and the exclusion criteria, were patients suffering from chronic psychiatry diseases.RESULTS:Affective psychopathology was indicated to result in a significant negative correlation with the quality of life of breast cancer patients which whom were treated with radiotherapy with p = 0.035 and r = -0.267. This suggests that with a higher HADS, a decrease in quality of life will occur.CONCLUSIONS:Affective psychopathological comorbidities have a great influence on the quality of life of patients who are undergoing radiotherapy. Thus, cancer management must include screening for psychopathological morbidity. Moreover, psychological rehabilitation must also be provided along with the cancer treatment.

Mapping EORTC-QLQ-C30 and QLQ-CR29 onto EQ-5D-5L in Colorectal Cancer Patients.

Patient-level utility data are needed for cost-utility analysis; in oncology, however, the data are commonly gathered using disease-specific questionnaires that are often not appropriate. Present study aimed to derive an algorithm which can map the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) scales and the Colorectal Cancer-Specific Quality Of Life Questionnaire (QLQ-CR29) scales onto the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) values in patients with colorectal cancer (CRC). Using the Ordinary Least Square (OLS) model, a cross-sectional dataset of 252 patients with CRC were gathered from three academic centers of cancer treatment in Tehran in 2017. The predicted R2 (Pred R2) and adjusted R2 (Adj R2) are used to evaluate model goodness of fit. Additionally, mean absolute error (MAE), root mean square error (RMSE), Spearman's correlation coefficients (ρ), and intraclass correlation (ICC) are applied to assess predictive ability of models. The tenfold cross-validation procedure was applied for validation models. According to the results of our study, the model C4 from EORTC QLQ-C30 was the best predictive model (Pred R2 = 66.57%, Adj R2 = 67.67%, RMSE = 0.10173, MAE = 0.07840). Also, the model R4 from QLQ-CR29 performed the best for EQ-5D-5L (Adj R2 = 48.42%, Pred R2 = 45.54%, MAE = 0.10051, RMSE = 0.12997). The mapping algorithm successfully mapped the EORTC QLQ-C30 and QLQ-CR29 scales onto the EQ-5D-5L values; therefore, it enables policymakers to convert cancer-specific questionnaires scores to the preference-based scores.

Early Palliative Care in Real-World Clinical Practice: Effectiveness Regarding Quality of Life and Symptoms of Newly Diagnosed Advanced Cancer Outpatients in Comprehensive Cancer Centres - A Multicentre, Mixed-Methods, Sequential Control Group Study (EVI Project)

Background: The evidence for early palliative care (EPC) often lacks external validity. Real-world clinical practice approaches are therefore urgently needed. This study aims to assess the effectiveness of EPC regarding patients' quality of life (QoL) and symptoms (secondary outcomes). Methods: This is a prospective, multicentre, mixed-methods, cohort study with a sequential control group design (DRK6162). We included adult outpatients with incurable advanced cancer diagnosed within the preceding eight weeks. The control group (CG) received standard oncology care and was compared to standard oncology care plus uniprofessional, EPC by a PC physician or PC nurse. We used mixed models to analyse the Palliative Outcome Scale (POS) and European Organization for Research and Treatment of Cancer QoL Questionnaire-C30 (EORTC QLQ-C30) at baseline, week 12, and week 24. Patients' and respective caregivers' subjective understanding of QoL was analysed with semi-structured interviews and content analysis. Findings: For the CG and intervention cohort (IG), we screened 1439 and 1716 patients, 338 and 254 entered the study, and 116 (34%) and 88 (35%) patients were available for Complete-Case analysis. Baseline characteristics were balanced between groups. For week 12, the POS score was 9·31 (95% confidence interval 8·25-10·37) in the CG and 9·74 (8·50-11·00) in the IG (difference: -0·44 (-2·45 to 1·58)). The QoL scale of the QLQ-C30 was 60·8 (95% confidence interval 56·9-64·8) in the CG and 55·1 (50·5-59·8) in the IG (difference: 5·7 (-1·8 to 13·2)). Subjective concepts of QoL were more differentiated in the IG (44 patients, 40 caregivers). Interpretation: QoL and symptoms were not different between groups. Qualitative data suggest a more elaborated concept of QoL in the IG. Future real-world studies are needed to find a balance between versus systemic as well as uniprofessional versus multiprofessional for an efficient and cost-effective EPC approach. Funding: Robert Bosch Stiftung: 11.5.1364.0055.0. Declaration of Interest: Siemens, W.: No competing interests to declare. Orellana-Rios, C.L.: No competing interests to declare. Schonsteiner, S. S.: No competing interests to declare. Schaekel, U.: No competing interests to declare. Kessler, J.: No competing interests to declare. Eschbach, C.: No competing interests to declare. Viehrig, M.: No competing interests to declare. Becker, G.: No competing interests to declare. Gaertner, J: No competing interests to declare. Ethical Approval: The Ethics Committee of the University of Freiburg (Germany) approved the study protocol on April 25, 2014 (vote: 193/14).

Differences in coping strategies among young adults and the elderly with cancer.

Coping with cancer and the oncologist-patient relationship can vary depending on the patient's age. Our aim is to examine and compare young and elderly adults with non-metastatic, resected cancer. Two groups of patients were selected, young (< 40 years) and elderly (> 70) with a diagnosis of non-metastatic, resected cancer requiring adjuvant chemotherapy from a pre-exiting, national database (NEOCOPING Study). Epidemiological variables were collected and subjects' emotional responses, perceptions of the physician-patient relationship, support network, fears, and regret about the decision to receive chemotherapy were assessed with questionnaires validated in previous studies: Mini-Mental Adjustment to Cancer, Brief Summary Inventory (18 items), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-C30, Shared Decision-Making Questionnaire-Physician's version, Shared Decision-Making Questionnaire-Patient's version, and Informed Risk (physician and patient versions). Data from 46 young and 46 elderly participants were collected. The most common neoplasms in both groups were breast (50%) and colorectal (22%). The younger adults had a higher level of education and were actively employed (72% vs. 7%). The leading coping strategy in the younger cohort was hope, and resignation among the elderly. Young adults sought more social support and the impact of diagnosis was more negative for them than for older individuals. No significant differences were detected in quality of life; both age groups demanded more time at their first visit with the doctor, while the older group exhibited greater satisfaction with shared decision-making. At the end of adjuvant chemotherapy, neither age group regretted their decision to receive said treatment. Higher levels of education, greater demands of the labour market, and the advent of the age of information have entailed drastic changes in the physician-patient relationship paradigm. This is especially true in the younger cancer patient population, who require more information and active participation in decision-making, can display more anxiety about their diagnosis, but also greater capacity to fight.

Need and demand for nutritional counselling and their association with quality of life, nutritional status and eating-related distress among patients with cancer receiving outpatient chemotherapy: a cross-sectional study.

Patients with cancer often experience general nutritional problems as the disease progresses. We aimed to examine if there is a need and demand for nutritional counselling among cancer outpatients, and explore relevant psychological factors pertaining to eating and nutrition. A survey was conducted among adult patients receiving outpatient chemotherapy at the Tokyo Medical and Dental University Hospital. The participants completed self-report questionnaires, which included questions on their nutritional state (Patient-Generated Subjective Global Assessment Short Form), experience of eating-related distress and quality of life (QOL) (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30). Of the 151 (median age, 66.5years) participants, 42 had a demand for nutritional counselling. Patients' experience of eating-related distress and demand for nutritional counselling were significantly associated, particularly in regard to 'conflicts over food between patients and the people surrounding them' (p = 0.005), 'concerns about food' (p = 0.007) and 'self-motivated effect related to nutrition' (p = 0.018). A significant association was also observed between the demand for nutritional counselling and global health status (p = 0.028), emotional functioning (p = 0.022), cognitive functioning (p = 0.028) and social functioning (p = 0.040) in terms of QOL. Patients with a low QOL tended to demand nutritional counselling. The demand for nutritional counselling was associated with QOL and eating-related distress. Therefore, medical staff caring for patients with cancer, such as attending physicians, dietitians, nurses, clinical psycho-oncologists, social workers and psychiatric oncologists, should collaborate and share information to provide nutritional counselling.

Moxibustion for alleviating side effects of chemotherapy or radiotherapy in people with cancer.

Moxibustion, a common treatment in traditional Chinese medicine, involves burning herbal preparations containing Artemisia vulgaris on or above the skin at acupuncture points. Its intended effect is to enhance body function, and it could reduce the side effects of chemotherapy or radiotherapy and improve quality of life (QoL) in people with cancer. To assess the effects of moxibustion for alleviating side effects associated with chemotherapy, radiotherapy or both in people with cancer. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE via Ovid, Embase via Ovid and AMED (Allied and Complementary Medicine Database) from their inception to February 2018. We also searched databases in China including the Chinese BioMedical Literature Database (CBM), Chinese Medical Current Contents (CMCC), TCMonline, Chinese Dissertation Database (CDDB), China Medical Academic Conference (CMAC) and Index to Chinese Periodical Literature from inception to August 2017. Registries for clinical trials and other resources were also searched. We included randomised controlled trials (RCTs) comparing moxibustion treatment, including moxa cone and moxa stick, versus sham, no treatment or conventional treatment. Two review authors (HWZ and FC) independently extracted data on study design, participants, treatment and control intervention, and outcome measures, and they also assessed risk of bias in the included studies. We performed meta-analyses, expressing dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean differences (MD), with 95% confidence intervals (CI). We included 29 RCTs involving 2569 participants. Five RCTs compared moxibustion versus no treatment, 15 compared moxibustion plus conventional treatment versus conventional treatment, one compared moxibustion versus sham moxibustion, and eight compared moxibustion versus conventional medicine. The overall risk of bias was high in 18 studies and unclear in 11 studies. Studies measured outcomes in various ways, and we could rarely pool data.Moxibustion versus no treatment: low-certainty evidence from single small studies suggested that moxibustion was associated with higher white blood cell counts (MD 1.77 × 109/L; 95% CI 0.76 to 2.78; 80 participants, low-certainty evidence) and higher serum haemoglobin concentrations (MD 1.33 g/L; 95% CI 0.59 to 2.07; 66 participants, low-certainty evidence) in people with cancer, during or after chemotherapy/radiotherapy, compared with no treatment. There was no evidence of an effect on leukopenia (RR 0.50, 95% CI 0.10 to 2.56; 72 participants, low-certainty evidence) between study groups. The effects on immune function (CD3, CD4, and CD8 counts) were inconsistent.Moxibustion versus sham moxibustion: low-certainty evidence from one study (50 participants) suggested that moxibustion improved QoL (measured as the score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)) compared with sham treatment (MD 14.88 points; 95% CI 4.83 to 24.93). Low-certainty evidence from this study also showed reductions in symptom scores for nausea and vomiting (MD -38.57 points, 95% CI -48.67 to -28.47) and diarrhoea (MD -13.81, 95% CI -27.52 to -0.10), and higher mean white blood cell count (MD 1.72 × 109/L, 95% CI 0.97 to 2.47), serum haemoglobin (MD 2.06 g/L, 95% CI 1.26 to 2.86) and platelets (MD 210.79 × 109/L, 95% CI 167.02 to 254.56) when compared with sham moxibustion.Moxibustion versus conventional medicines: low-certainty evidence from one study (90 participants) suggested that moxibustion improved WBC count eight days after treatment ended compared with conventional medicines (MD 0.40 × 109/L; 95% CI 0.15 to 0.65). Low-certainty evidence from two studies (235 participants) suggested moxibustion improved serum haemoglobin concentrations compared with conventional medicines (MD 10.28 g/L; 95% CI 4.51 to 16.05).Moxibustion plus conventional treatment versus conventional treatment alone: low-certainty evidence showed that moxibustion plus conventional treatment was associated with lower incidence and severity of leukopenia (WHO grade 3 to 4) (RR 0.14, 95% CI 0.01 to 2.64; 1 study, 56 participants), higher QoL scores on the EORTC QLQ-C30 (MD 8.85 points, 95% CI 4.25 to 13.46; 3 studies, 134 participants, I² = 26%), lower symptom scores for nausea and vomiting (RR 0.43, 95% CI 0.25 to 0.74; 7 studies, 801participants; I² = 19%), higher white blood cell counts (data not pooled due to heterogeneity), higher serum haemoglobin (MD 3.97 g/L, 95% CI 1.40 to 6.53; 2 studies, 142 participants, I² = 0%). There was no difference in platelet counts between the two groups (MD 13.48 × 109/L; 95% CI -16.00 to 42.95; 2 studies, 142 participants; I² = 34%).Most included studies did not report related adverse events, such as burning or allergic reactions. Limited, low-certainty evidence suggests that moxibustion treatment may help to reduce the haematological and gastrointestinal toxicities of chemotherapy or radiotherapy, improving QoL in people with cancer; however, the evidence is not conclusive, and we cannot rule out benefits or risks with this treatment. High-quality studies that report adverse effects are needed.