Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours
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ABSTRACT:
DISEASE(S): Neuroendocrine Tumors,Gastrointestinal Neuroendocrine Tumours,Pancreatic Neoplasms,Stomach Neoplasms,Intestinal Neoplasms
PROVIDER: 2221368 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:BACKGROUND: Quality of life is an important end point in clinical trials, yet there are few quality of life questionnaires for neuroendocrine tumours. METHODS: This international multicentre validation study assesses the QLQ-GINET21 Quality of Life Questionnaire in 253 patients with gastrointestinal neuroendocrine tumours. All patients were requested to complete two quality of life questionnaires - the EORTC Core Quality of Life questionnaire (QLQ-C30) and the QLQ-GINET21 - at baseline, and at 3 and 6 months post-baseline; the psychometric properties of the questionnaire were then analysed. RESULTS: Analysis of QLQ-GINET21 scales confirmed appropriate aggregation of the items, except for treatment-related symptoms, where weight gain showed low correlation with other questions in the scale; weight gain was therefore analysed as a single item. Internal consistency of scales using Cronbach's α coefficient was >0.7 for all parts of the QLQ-GINET21 at 6 months. Intraclass correlation was >0.85 for all scales. Discriminant validity was confirmed, with values <0.70 for all scales compared with each other.Scores changed in accordance with alterations in performance status and in response to expected clinical changes after therapies. Mean scores were similar for pancreatic and other tumours. CONCLUSION: The QLQ-GINET21 is a valid and responsive tool for assessing quality of life in the gut, pancreas and liver neuroendocrine tumours.
| S-EPMC3566824 | biostudies-other
Project description:IntroductionPatients with midgut neuroendocrine tumours (NETs) suffer from decreased health-related quality of life (HRQoL), in large part due to bowel symptoms. However, it is unknown which bowel symptoms affect HRQoL the most. An enhanced understanding of this is essential to better focus treatment on this aspect of the disease. This study aimed to determine which bowel symptoms affect HRQoL the most in patients with midgut NETs.MethodsConsenting patients with midgut NET completed the Memorial Sloan Kettering Bowel Function Instrument and the HRQoL questionnaire (EORTC QLQ-C30). The correlation between bowel symptoms and HRQoL was analysed using multiple linear regression, adjusting for age, Charlson Comorbidity Index score, presence of metastatic disease, chromogranin A, and BMI yielding ß-coefficients with 95% confidence intervals.ResultsTotally, 119 patients with midgut NET completed the questionnaires and were included in the study. Loose stool and bowel frequency ≥ 3/day were the most common bowel symptoms, reported by 47% and 56% of patients, respectively. However, sensitivity to certain types of food and beverages, a feeling of incomplete emptying of the bowel, and soiling were the symptoms most strongly correlated with decreased HRQoL, especially within domains concerning role and social function, with ß-coefficients for the strongest correlated symptoms of 15.0 and 14.6, respectively.DiscussionWhile symptoms concerning stool consistency and frequency are common in patients with midgut NET, our study suggests that other, more socially stigmatising symptoms affect patients' HRQoL more. Our findings could help caregivers understand patients' perceptions of the disease and provide avenues for more directed therapies.
| S-EPMC8321966 | biostudies-literature
Project description:Neuroendocrine tumours (NET) are often diagnosed at an advanced stage when the prognosis is poor for patients, who often experience diminished quality of life (QoL). As new treatments for NET become available, it is important to characterise the associated outcomes, costs and QoL. A comprehensive search was performed to systematically review available data in advanced NET regarding cost of illness/resource utilisation, economic studies/health technology assessment and QoL. Four rounds of sequential review narrowed the search results to 22 relevant studies. Most focused on surgical procedures and diagnostic tools and contained limited information on the costs and consequences of medical therapies. Multiple tools are used to assess health-related QoL in NET, but few analyses have been conducted to assess the comparative impact of available treatment alternatives on QoL. Limitations include English language and the focus on advanced NET; ongoing terminology and classification changes prevented pooled statistical analyses. This systematic review suggests a lack of comparative economic and outcomes data associated with NET treatments. Further research on disease costs, resource utilisation and QoL for patients with advanced NET is warranted.
| S-EPMC4208687 | biostudies-literature
Project description:Primary outcome(s): Pilot testing of the approved Hindi and Marathi translations of the EORTC QLQ-CR29
Timepoint: 6 months
| 28250 | ecrin-mdr-crc
Project description:Tumours can escape the immune system by expressing programmed death-ligand-1 (PD-L1), which allows them to bind to PD-1 on T-cells and avoid recognition by the immune system. Regulatory T-cells (Tregs), indoleamine 2,3-dioxygenase (IDO) and tryptophan 2,3-dioxygenase (TDO) also play a role in immune suppression. Knowledge about the interaction of neuroendocrine tumours (NETs) with their immune microenvironment and the role of immunotherapy in patients with NET is scarce. Here, we investigated the immune microenvironment of serotonin-producing (SP) and non-serotonin-producing NETs (NSP-NETs). Tumours of 33 patients with SP-NET and 18 patients with NSP-NET were studied. Immunohistochemical analyses were performed for PD-L1, T-cells, IDO, TDO, mismatch repair proteins (MMRp) and activated fibroblasts. PD-L1 expression was seen in <?1% of tumour and T-cells. T-cells were present in 33% of NETs, varying between 1 and 10% T-cells per high power field. IDO was expressed in tumour cells in 55% of SP-NETs and 22% of NSP-NETs (p?=?0.039). TDO was expressed in stromal cells in 64% of SP-NETs and 13% of NSP-NETs (p?=?0.001). No tumours had loss of MMRp. TDO-expressing stromal cells also strongly expressed ?-SMA and were identified as cancer-associated fibroblasts (CAFs). Factors that are associated with a response to checkpoint inhibitor treatment were absent or only present to a limited extent in the tumour microenvironment of NETs. The expression of IDO and TDO in a substantial part of NETs and the presence of CAFs suggest two mechanisms that could be responsible for the cold immune microenvironment, which should be explored to enhance anti-tumour immunity and clinical responses.
| S-EPMC7347684 | biostudies-literature
Project description:Neuroendocrine tumours (NETs) constitute a heterogeneous group of neoplasms characterised by variable endocrine activity and somatostatin receptor expression, with the latter allowing the use of targeted therapeutic concepts. Currently accepted treatment strategies for advanced well-differentiated NET include somatostatin analogues octreotide and lanreotide, peptide receptor radionuclide therapy using radiolabelled somatostatin analogues, mammalian target of Rapamycin inhibitor everolimus, tyrosine kinase inhibitor sunitinib, interferon alpha and classical cytostatic, such as streptozotocin-based and temozolomide-based treatment. Indication, use and approval of these treatments differ based on primary tumour origin, grading and symptomatic burden and require an optimised multidisciplinary cooperation of medical oncologists, endocrinologists and nuclear medicine specialists. Interestingly, hot topics in oncology including immunotherapy and use of next-generation-sequencing techniques currently play a minor role for the treatment of NETs. The recent revision of the WHO classification including the recognition of the novel NET G3 category allows for potentially more tailored treatment strategies in the near future. However, this new entity also poses a therapeutic challenge as only limited data are currently available. The present article aims to provide an overview on our personal treatment concepts for advanced NETs with a focus on tumours of gastroenteropancreatic origin.
| S-EPMC7440715 | biostudies-literature
Project description:BACKGROUND:Domains other than those commonly measured (physical, psychological, social, and sometimes existential/spiritual) are important to the quality of life of people with life-threatening illness. The McGill Quality of Life Questionnaire (MQOL) - Revised measures the four common domains. The aim of this study was to create a psychometrically sound instrument, MQOL - Expanded, to comprehensively measure quality of life by adding to MQOL-Revised the domains of cognition, healthcare, environment, (feeling like a) burden, and possibly, finance. METHODS:Confirmatory factor analyses were conducted on three datasets to ascertain whether seven new items belonged with existing MQOL-Revised domains, whether good model fit was obtained with their addition as five separate domains to MQOL-Revised, and whether a second-order factor representing overall quality of life was present. People with life-threatening illnesses (mainly cancer) or aged > 80 were recruited from 15 healthcare sites in seven Canadian provinces. Settings included: palliative home care and inpatient units; acute care units; oncology outpatient clinics. RESULTS:Good model fit was obtained when adding each of the five domains separately to MQOL-Revised and for the nine correlated domains. Fit was acceptable for a second-order factor model. The financial domain was removed because of low importance. The resulting MQOL-Expanded is a 21-item instrument with eight domains (fit of eight correlated domains: Comparative Fit Index = .96; Root Mean Square Error of Approximation = .033). CONCLUSIONS:MQOL-Expanded builds on MQOL-Revised to more comprehensively measure the quality of life of people with life-threatening illness. Our analyses provide validity evidence for the MQOL-Expanded domain and summary scores; the need for further validation research is discussed. Use of MQOL-Expanded will enable a more holistic understanding of the quality of life of people with a life-threatening illness and the impact of treatments and interventions upon it. It will allow for a better understanding of less commonly assessed but important life domains (cognition, healthcare, environment, feeling like a burden) and their relationship to the more commonly assessed domains (physical, psychological, social, existential/spiritual).
| S-EPMC6823967 | biostudies-literature
Project description:ObjectiveTo develop a primary aldosteronism (PA) disease-specific Health-Related Quality of Life (HRQoL) questionnaire.MethodsWe included newly diagnosed patients with PA (n = 26), and patients with PA after adrenalectomy (n = 25) or treated with mineralocorticoid receptor antagonists (n = 25). According to the guidelines for developing HRQoL questionnaires from the European Organization for Research and Treatment of Cancer (EORTC): Phase I: systematic literature review followed by focus group meetings with patients (n = 13) resulting in a list of 94 HRQoL issues. Relevance of issues was rated by 18 other patients and by health care professionals (n = 15), resulting in 30 remaining issues. Phase II: selected issues were converted into questions. Phase III: the provisional questionnaire was pre-tested by a third group of patients (n = 45) who also completed the EORTC core Quality of Life questionnaire (QLQ-C30). Psychometric testing resulted in a final selection of questions with their scale structure.ResultsAfter the collection and selection of HRQoL issues a provisional questionnaire consisting of 30 items was formed. Of these items, 26 could be assigned to one of the four scales 'physical and mental fatigue', 'anxiety and stress', 'fluid balance' and 'other complaints' cumulatively accounting for 68% of variation in all items. All scales had good reliability and validity. There was a significant correlation of all four scales with the QLQ-C30 in most cases.ConclusionsWe developed the first PA-specific HRQoL questionnaire (PA-QoL) using standard, methodologically proven guidelines. After completion of the final validation (phase IV, international field testing), the questionnaire can be implemented into clinical practice.
| S-EPMC6454297 | biostudies-literature
Project description:PurposeWe report the development of a patient-derived, health-related quality-of-life (HRQOL) questionnaire for adults with strabismus.DesignCross-sectional study.ParticipantsTwenty-nine patients with strabismus in a first phase, and 32 patients with strabismus, 18 patients with other eye diseases, and 13 visually normal adults in a second phase.MethodsIndividual patient interviews generated 181 questionnaire items. For item reduction, we asked 29 patients with strabismus to complete the 181-item questionnaire, analyzed responses, and performed factor analysis. Two prominent factors were identified, and the 10 items with the highest correlation with each factor were selected. The final 20-item questionnaire (10 psychosocial items and 10 function items) was administered to an additional 32 patients with strabismus (22 with diplopia, 10 without diplopia), 13 visually normal adults, and 18 patients with other eye diseases. A 5-point Likert-type scale was used for responses (never = 100, rarely = 75, sometimes = 50, often = 25, and always = 0). Median overall questionnaire scores and psychosocial and function subscale scores, ranging from 0 (worst HRQOL) to 100 (best HRQOL), were compared across groups.Main outcome measuresThe HRQOL questionnaire response scores.ResultsMedian overall scores were statistically significantly lower (worse quality of life) for patients with strabismus (56) compared with visually normal adults (95; P<0.001) and patients with other eye diseases (86; P<0.001). Median scores on the psychosocial subscale were significantly lower for strabismus patients (69) compared with visually normal adults (99; P<0.001) and patients with other eye diseases (94; P<0.001). For the function subscale, median scores were again significantly lower for strabismus patients (43) compared with visually normal adults (91; P<0.001) and patients with other eye diseases (78; P<0.001).ConclusionsWe have developed a 20-item, patient-derived, HRQOL questionnaire specific for adults with strabismus, with subscales to assess psychosocial and function concerns. This 20-item, condition-specific questionnaire will be useful for assessing HRQOL in individual strabismus patients and also as an outcome measure for clinical trials.Financial disclosure(s)The authors have no proprietary or commercial interest in any materials discussed in this article.
| S-EPMC2817952 | biostudies-literature
Project description:The study aimed to carry on the process of the cultural adaptation of the Italian Spine Youth Quality of Life Questionnaire (ISYQOL) into Polish (ISYQOL-PL). The a priori hypothesis was: the ISYQOL-PL questionnaire is reliable and appropriate for adolescents with a spinal deformity. Fifty-six adolescents (mean age 13.8 ± 1.9) with idiopathic scoliosis (AIS) with a mean Cobb angle 29.1 (±9.7) and two with Scheuermann juvenile kyphosis (SJK) with a kyphosis angle 67.5 (±17.7) degrees were enrolled. All patients had been wearing a corrective TLSO brace for an average duration of 2.3 (±1.8) years. The Institutional Review Board approved the study. The cross-cultural adaptation of the ISYQOL-PL was performed following the guidelines set up by the International Quality of Life Assessment Project. The reliability was assessed using internal consistency (the Cronbach's alpha coefficient) and test-retest reliability (intraclass correlation coefficient ICC2.1, CI = 95%); moreover, floor and ceiling effects were calculated. The internal consistency was satisfactory (Cronbach's alpha coefficient 0.8). The test-retest revealed high reliability with the value of ICC2.1 for the entire group 0.90, CI (0.84 to 0.94). There was neither floor nor ceiling effect for the ISYQOL-PL overall score. The ISYQOL-PL is reliable and can be used in adolescents with spinal deformity.
| S-EPMC8151829 | biostudies-literature