scholarly journals Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG)

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e035546
Author(s):  
Leopold Hentschel ◽  
Stephan Richter ◽  
Hans-Georg Kopp ◽  
Bernd Kasper ◽  
Annegret Kunitz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Functional Assessment ◽  
Patient Reported Outcomes ◽  
Statistical Significance ◽  
Case Vignette ◽  
Cluster Randomised ◽  
Patient Reported

ObjectivesThe choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.DesignYonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.ParticipantsSix hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.Primary and secondary outcome measuresThe primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.ResultsAfter 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: −2.4, 95% CI: −9.2 to 4.5) as compared with CA (ΔFACT-G total score: −3.9; 95% CI:−11.3 to 3.5; p=0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p=0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.ConclusionOur data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.Trial registration numberClinicalTrials.gov Identifier (NCT02204111).

scholarly journals Quality of life and experiences of sarcoma trajectories (the QUEST study): protocol for an international observational cohort study on diagnostic pathways of sarcoma patients

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039309
Author(s):  
Vicky Soomers ◽  
Ingrid ME Desar ◽  
Lonneke V van de Poll-Franse ◽  
Olga Husson ◽  
Winette TA van der Graaf
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
The Netherlands ◽  
Patient Reported Outcomes ◽  
Tumour Size ◽  
Patient Reported ◽  
Total Interval

IntroductionSarcomas are rare tumours with considerable heterogeneity. Early and accurate diagnosis is important to optimise patient outcomes in terms of local disease control, overall survival (OS) and health-related quality of life (HRQoL). Time to diagnosis is variable in bone as well as soft tissue sarcoma. Possible factors for a long time from first symptom to diagnosis (the total interval) include patient, tumour and healthcare characteristics, but until now the most relevant risk factors and its association with outcomes remain unknown. Our study aims to (1) quantify total interval, the time interval from first symptom until (histological) diagnosis; (2) identify factors associated with interval length and (3) determine the association between total interval and HRQoL, stage and tumour size at diagnosis, progression-free survival (PFS) and OS.Methods and analysisWe will conduct a longitudinal, prospective, international, multicentre cohort study among patients aged ≥18 years with newly diagnosed bone or soft tissue sarcoma at eight centres (three in UK, five in The Netherlands). Patients will be asked to complete questionnaires at five points in time; one at diagnosis and at follow-up points of 3, 6, 12 and 24 months. Questionnaire data is collected within the Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES) registry: an international data management system for collection of patient-reported outcomes. Clinical data will be extracted from patient records. The primary endpoint is HRQoL at diagnosis, measured with the EORTC QLQ-C30. Secondary endpoints are stage and tumour size at diagnosis, PFS, OS, additional patient-reported outcomes, such as quality-adjusted life years and psychological distress.Ethics and disseminationEthical approval was given by the Health Research Authority and Research Ethics Committee for the United Kingdom (18/WA/0096) and medical ethical committee of Radboudumc for The Netherlands (2017-3881). Results will be presented in peer-reviewed journals and presented at meetings.Trial registration numberNCT03441906.

scholarly journals Acupuncture for Breast Cancer: A Systematic Review and Meta-Analysis of Patient-Reported Outcomes

2021 ◽  
Vol 11 ◽  
Author(s):  
Yuzhu Zhang ◽  
Yang Sun ◽  
Dongmei Li ◽  
Xiaoyuan Liu ◽  
Chen Fang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Systematic Review ◽  
Cancer Therapy ◽  
Functional Assessment ◽  
Patient Reported Outcomes ◽  
Meta Analysis ◽  
Hot Flashes ◽  
Patient Reported

AbstractThe present systematic review and meta-analysis was undertaken to evaluate the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).MethodsA comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers.ResultsOut of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results.ConclusionsCurrent evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.

Patient-Reported Outcomes in Breast Oncology: A Review of Validated Outcome Instruments

2012 ◽  
Vol 98 (6) ◽  
pp. 678-688 ◽  
Author(s):  
Anastasios Kanatas ◽  
Galina Velikova ◽  
Brenda Roe ◽  
Kieran Horgan ◽  
Naseem Ghazali ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Body Image ◽  
Functional Assessment ◽  
Patient Reported Outcomes ◽  
Breast Cancer Treatment ◽  
Body Image Scale ◽  
Patient Reported ◽  
Related Quality

Aims and background Patient-reported outcomes (PROs) include areas of health-related quality of life but also broader concepts such as patient satisfaction with care. The aim of this review is to give an account of all instruments with potential use in patients with a history of treatment for breast cancer (including surgery, chemotherapy and/or radiotherapy) with evidence of validation in the breast cancer population. Methods All instruments included in this review were identified as PRO measures measuring breast-related quality of life and/or satisfaction that had undergone development and validation with breast oncology patients. We specifically looked for PRO measures examining patient satisfaction and/or quality of life after breast cancer treatment. Following an evaluation of 323 papers, we identified 15 instruments that were able to satisfy our inclusion criteria. Results These instruments are the EORTC QOL-C30 and QLQ-BR23 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module), the FACT-B (Functional Assessment of Cancer Therapy-Breast Cancer), the SLDS-BC (Satisfaction with Life Domains Scale for Breast Cancer), the BIBCQ (Body Image after Breast Cancer Questionnaire), the HIBS (Hopwood Body Image Scale), the PBIS (Polivy Body Image Scale), the MBROS (Michigan Breast Reconstruction Outcomes Study) Satisfaction and Body Image Questionnaires, the BREAST-Q, the BCTOS (Breast Cancer Treatment Outcome Scale), the BCQ, the FACT-ES (Functional Assessment of Cancer Therapy-Endocrine System), the MAS (Mastectomy Attitude Scale), and the Breast Cancer Prevention Trial Symptom Checklist (BCPT). Conclusions Suggestions for future directions include (1) to use and utilize validated instruments tailored to clinical practice; (2) to develop a comprehensive measurement of surgical outcome requiring the combination of objective and subjective measures; (3) to aim for a compromise between these two competing considerations in the form of a scale incorporating both generalizability in cancer-related QOL and specificity in breast cancer issues.

P048 QUALITY OF LIFE AND OTHER PATIENT REPORTED OUTCOMES IN PATIENTS WITH POUCHITIS

2020 ◽  
Vol 158 (3) ◽  
pp. S107
Author(s):  
Edward Barnes ◽  
Millie Long ◽  
Laura Raffals ◽  
Xian Zhang ◽  
Anuj Vyas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Patient Reported

Understanding quality of life and treatment history of patients with Bertolotti syndrome compared with lumbosacral radiculopathy

2019 ◽  
Vol 31 (2) ◽  
pp. 222-228 ◽  
Author(s):  
Joshua L. Golubovsky ◽  
Arbaz Momin ◽  
Nicolas R. Thompson ◽  
Michael P. Steinmetz
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Propensity Score ◽  
Disc Herniation ◽  
Symptom Onset ◽  
Patient Reported Outcomes ◽  
Lumbosacral Radiculopathy ◽  
Patient Reported ◽  
Age And Sex

OBJECTIVEBertolotti syndrome is a rare spinal condition that causes low-back pain due to a lumbosacral transitional vertebra (LSTV), which is a pseudoarticulation between the fifth lumbar transverse process and the sacral ala. Bertolotti syndrome patients are rarely studied, particularly with regard to their quality of life. This study aimed to examine the quality of life and prior treatments in patients with Bertolotti syndrome at first presentation to the authors’ center in comparison with those with lumbosacral radiculopathy.METHODSThis study was a retrospective cohort analysis of patients with Bertolotti syndrome and lumbosacral radiculopathy due to disc herniation seen at the authors’ institution’s spine center from 2005 through 2018. Diagnoses were confirmed with provider notes and imaging. Variables collected included demographics, diagnostic history, prior treatment, patient-reported quality of life metrics, and whether or not they underwent surgery at the authors’ institution. Propensity score matching by age and sex was used to match lumbosacral radiculopathy patients to Bertolotti syndrome patients. Group comparisons were made using t-tests, Fisher’s exact test, Mann-Whitney U-tests, Cox proportional hazards models, and linear regression models where variables found to be different at the univariate level were included as covariates.RESULTSThe final cohort included 22 patients with Bertolotti syndrome who had patient-reported outcomes data available and 46 propensity score–matched patients who had confirmed radiculopathy due to disc herniation. The authors found that Bertolotti syndrome patients had significantly more prior epidural steroid injections (ESIs) and a longer time from symptom onset to their first visit. Univariate analysis showed that Bertolotti syndrome patients had significantly worse Patient-Reported Outcomes Measurement Information System (PROMIS) mental health T-scores. Adjustment for prior ESIs and time from symptom onset revealed that Bertolotti syndrome patients also had significantly worse PROMIS physical health T-scores. Time to surgery and other quality of life metrics did not differ between groups.CONCLUSIONSPatients with Bertolotti syndrome undergo significantly longer workup and more ESIs and have worse physical and mental health scores than age- and sex-matched patients with lumbosacral radiculopathy. However, both groups of patients had mild depression and clinically meaningful reduction in their quality of life according to all instruments. This study shows that Bertolotti syndrome patients have a condition that affects them potentially more significantly than those with lumbosacral radiculopathy, and increased attention should be paid to these patients to improve their workup, diagnosis, and treatment.

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