Dataset Information

Patient reported symptoms associated with quality of life during chemo- or immunotherapy for bladder cancer patients with advanced disease.

ABSTRACT:

Background

Bladder cancer (BC) patients with advanced disease have poor outcomes. The use of patient-reported outcomes (PROs) could lead to improvements in symptom management and hence quality of life (QoL). The aim of this study is to report correlations between selected PROs and QoL and thus to present symptoms that influence QoL. Identification of these symptoms during treatment can lead to earlier symptom management and thus secure improvements in QoL.

Methods

BC patients in chemo- or immunotherapy for locally advanced or metastatic disease reported weekly PROs for the duration of their treatment. The PROs included EORTC QLQ-C30 and QLQ-BLM30 and 45 selected PRO-CTCAE items. Spearman's correlation analysis was performed for all PRO-CTCAE items and QLQ-C30 global QoL and subdomains.

Results

In this study, 78 BC patients reported 724 questionnaires. Spearman's analysis showed significant correlations between almost all PRO-CTCAE items and the expected domain of QoL. The PRO-CTCAE items with the strongest correlations with QoL were anxiety (F, frequency item) and emotional function (r_s = -0.603, P < .0001), concentration (S, severity item) and cognitive function (r_s = -0.704, P < .0001), discouraged (F) and emotional function (r_s = -0.659, P < .0001), fatigue (S) and role function (r_s = -0.659, P < .0001) and sad (F) and emotional function (r_s = -0.711, P < .0001). The weakest correlations were found for the PRO-CTCAE items urinary frequency, incontinence and urge, all with variations in the direction and significance of the correlations.

Conclusions

This study delivers information on which PROs may influence QoL for patients in clinical trials or daily clinic. Psychological issues have a strong impact on QoL and should be dealt with during treatment to secure the best possible QoL for BC patients.

SUBMITTER: Taarnhoj GA

PROVIDER: S-EPMC7196058 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

Patient reported symptoms associated with quality of life during chemo- or immunotherapy for bladder cancer patients with advanced disease.

Taarnhøj Gry A GA Johansen Christoffer C Lindberg Henriette H Basch Ethan E Dueck Amylou A Pappot Helle H

Cancer medicine 20200310 9

<h4>Background</h4>Bladder cancer (BC) patients with advanced disease have poor outcomes. The use of patient-reported outcomes (PROs) could lead to improvements in symptom management and hence quality of life (QoL). The aim of this study is to report correlations between selected PROs and QoL and thus to present symptoms that influence QoL. Identification of these symptoms during treatment can lead to earlier symptom management and thus secure improvements in QoL.<h4>Methods</h4>BC patients in c ...[more]

PMID: 32154663

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Project description:BACKGROUND:Selection of specific patient-reported outcomes (PROs) for cancer patients requires careful consideration to the purpose and population at aim. Here we report the process of choosing which items to include in a bladder cancer population in chemo- or immunotherapy based on the Patient-Reported Outcomes Version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE). METHODS:Initial PRO-CTCAE symptoms were chosen through 1) medical record audit 2) patient interviews 3) summary of product characteristics from European Medicines Agency and Food and Drug Administration for the applied chemotherapies, and 4) toxicity reporting from Phase 2 and 3 trials for immunotherapies applied in patients with urothelial cancer. The selected questions were applied in a prospective cohort of 78 bladder cancer patients receiving chemo- or immunotherapy at Rigshospitalet and Herlev Hospital, Denmark. Symptoms tested in this population were selected for the final module if they appeared in ?3 of the following groupings a) the most prevalent PRO-CTCAE symptoms grade???2 overall during treatment b) the PRO-CTCAE symptoms reported in conjunction with hospital admissions or mentioned in focus group interviews discussing which symptoms were prevalent in this patient group with specialized c) nurses or d) physicians. The authors also included symptoms in the final module if they were present in two of the above groups and defined as actionable by clinicians. RESULTS:From the initial selection of PRO-CTCAE symptoms, a total of 45 PRO-CTCAE symptoms explored by 84 PRO-CTCAE questions were retrieved. Through the second selection process based on the described criteria, the study group agreed on 15 PRO-CTCAE symptoms explored by 30 PRO-CTCAE items to be appropriate and relevant for the bladder population during medical oncological treatment. CONCLUSIONS:The selection of disease specific PROs in a bladder cancer population was feasible. The process revealed several steps of selection needed in order to reach a final module for clinical application.

Project description:BackgroundLittle is known about health-related quality of life (HRQOL) following treatment for bladder cancer (BC).ObjectiveTo determine this, we undertook a cross-sectional survey covering 10% of the English population.Design, setting, and participantsParticipants 1-10 yr from diagnosis were identified through national cancer registration data.InterventionA postal survey was administered containing generic HRQOL and BC-specific outcome measures. Findings were compared with those of the general population and other pelvic cancer patients.Outcome measurements and statistical analysisGeneric HRQOL was measured using five-level EQ-5D (EQ-5D-5L) and European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30. BC-specific outcomes were derived from EORTC QLQ-BLM30 and EORTC QLQ-NMIBC24.Results and limitationsA total of 1796 surveys were completed (response rate 55%), including 868 (48%) patients with non-muscle-invasive BC, 893 (50%) patients who received radiotherapy or radical cystectomy, and 35 (1.9%) patients for whom treatment was unknown. Most (69%) of the participants reported at least one problem in any EQ-5D dimension. Age/sex-adjusted generic HRQOL outcomes were similar across all stages and treatment groups, whilst problems increased with age (problems in one or more EQ-5D dimensions: <65 yr [67% {95% confidence interval or CI: 61-74}] vs 85+ yr [84% {95% CI: 81-89}], p = 0.016) and long-term conditions (no conditions [53% {95% CI: 48-58}] vs more than four conditions [94% {95% CI: 90-97}], p < 0.001). Sexual problems were reported commonly in men, increasing with younger age and radical treatment. Younger participants (under 65 yr) reported more financial difficulties (mean score 20 [95% CI: 16-25]) than those aged 85+ yr (6.8 [4.5-9.2], p < 0.001). HRQOL for BC patients (for comparison, males with problems in one or more EQ-5D dimensions 69% [95% CI: 66-72]) was significantly worse than what has been found after colorectal and prostate cancers and in the general population (51% [95% CI: 48-53], all p < 0.05).ConclusionsHRQOL following BC appears to be relatively independent of disease stage, treatment, and multimodal care. Issues are reported with sexual function and financial toxicity. HRQOL after BC is worse than that after other pelvic cancers.Patient summaryPatients living with bladder cancer often have reduced quality of life, which may be worse than that for other common pelvic cancer patients. Age and other illnesses appear to be more important in determining this quality of life than the treatments received. Many men complain of sexual problems. Younger patients have financial worries.

Project description:IntroductionDirectly recorded patient experience of symptoms and health-related quality of life (HRQoL) can complement lung function and exacerbation rate data in chronic obstructive pulmonary disease (COPD) clinical studies. The FULFIL study recorded daily symptoms and activity limitation together with additional patient-reported outcomes of dyspnea and HRQoL, as part of the prespecified analyses. FULFIL co-primary endpoint data have been previously reported.MethodsFULFIL was a phase III, 24-week, randomized, double-blind, double-dummy, multicenter study comparing once-daily single inhaler triple therapy [fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)] 100 µg/62.5 µg/25 µg with twice-daily inhaled corticosteroid/long-acting β2-agonist therapy [budesonide/formoterol (BUD/FOR)] 400 µg/12 µg in patients with symptomatic COPD at risk of exacerbations. A subset participated for 52 weeks. Patient-reported assessments were: Evaluating Respiratory Symptoms in COPD™ (E-RS: COPD), St George's Respiratory Questionnaire (SGRQ) for COPD, COPD Assessment Test (CAT), baseline and transitional dyspnea indices (TDI) and daily and global anchor questions for activity limitation.ResultsFF/UMEC/VI showed greater reductions from baseline in 4-weekly mean E-RS: COPD total and all subscale scores compared with BUD/FOR; differences were statistically significant (P < 0.05) at each time period. FF/UMEC/VI also demonstrated greater improvements from baseline at weeks 4 and 24 in SGRQ domain scores and TDI focal score compared with BUD/FOR. At weeks 4 and 24, improvements greater than the minimal clinically important difference from baseline were observed in CAT score with FF/UMEC/VI, but not BUD/FOR; differences were statistically significant (P ≤ 0.003).ConclusionThese findings demonstrate sustained daily symptom and HRQoL benefits of FF/UMEC/VI versus BUD/FOR. The inclusion of the CAT may provide data that are readily generalizable to everyday clinical practice.Trial registrationClinicalTrials.gov number: NCT02345161.FundingGSK.

Project description:BackgroundQuality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β3 -adrenergic receptor agonist that showed efficacy in treatment of symptoms of OAB in the randomised, double-blind, placebo- and active-controlled phase 3 EMPOWUR trial. Here we report patient-reported QOL outcomes from the EMPOWUR trial.MethodsPatients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo or tolterodine 4 mg extended release, respectively, for 12 weeks. Patients completed the OAB questionnaire (OAB-q) at baseline and at week 12 and the patient global impression (PGI) scales for severity, control, frequency and leakage at baseline and at weeks 4, 8 and 12. Change from baseline at week 12 and responder rates (OAB-q: patients achieving a ≥10-point improvement; PGI: patients reporting best possible response) were assessed. Vibegron was compared with placebo, and no comparisons were made between vibegron and tolterodine.ResultsOf the 1518 patients randomised, 1463 (placebo, n = 520; vibegron, n = 526; tolterodine, n = 417) had evaluable data for efficacy measures and were included in the analysis. Mean baseline OAB-q and PGI scores were comparable among treatment groups. At week 12, patients receiving vibegron had greater improvements from baseline in OAB-q subscores of coping, concern, sleep, health-related QOL total and symptom bother (P < .01 each) compared with patients receiving placebo; a greater proportion of patients receiving vibegron vs placebo were responders in the OAB-q coping (P < .05) and symptom bother scores (P < .0001). Compared with placebo, a greater proportion of patients who received vibegron achieved the best response on all PGI end-points at week 12 (P < .05 each) and were classified as responders (P < .05 each).ConclusionsIn the 12-week EMPOWUR trial, treatment with vibegron was associated with significantly greater and clinically meaningful improvement in OAB-q and PGI scores compared with placebo, consistent with improvements in OAB symptoms.Clinical trial registrationClinicalTrials.gov identifier number NCT03492281.

Project description:BACKGROUND:Oral immunotherapy (OIT) can lead to desensitization to food allergens, but patients can experience treatment-related symptoms of allergic reactions that cause anxiety and treatment dropout. Interventions to improve OIT for patients are needed. OBJECTIVE:To determine whether fostering the mindset that non-life-threatening symptoms during OIT can signal desensitization improves treatment experience and outcomes. METHODS:In a randomized, blinded, controlled phase II study, 50 children/adolescents (28% girls, aged 7-17 years, M = 10.82, standard deviation = 3.01) completed 6-month OIT for peanut allergies. Patients and their parent(s) had monthly clinic visits at the Sean N. Parker Center for Allergy and Asthma Research between January 5, 2017, and August 3, 2017. All families received identical symptom management training. In a 1:1 approach, 24 patients and their families were informed that non-life-threatening symptoms during OIT were unfortunate side effects of treatment, and 26 patients and their families were informed that non-life-threatening symptoms could signal desensitization. Families participated in activities to reinforce these symptom mindsets. RESULTS:Compared with families informed that symptoms are side effects, families informed that symptoms can signal desensitization were less anxious (B = -0.46, 95% confidence interval [CI]: -0.76 to -0.16; P = .003), less likely to contact staff about symptoms (5/24 [9.4%] vs 27/154 [17.5%] instances; P = .036), experienced fewer non-life-threatening symptoms as doses increased (BInteraction = -0.54, 95% CI: -0.83 to -0.27; P < .001), less likely to skip/reduce doses (1/26 [4%] vs 5/24 [21%] patients; P = .065), and showed a greater increase in patient peanut-specific blood IgG4 levels (BInteraction = 0.76, 95% CI: 0.36 to 1.17; P < .001). CONCLUSIONS:Fostering the mindset that symptoms can signal desensitization improves OIT experience and outcomes. Changing how providers inform patients about non-life-threatening symptoms is a promising avenue for improving treatment.

Project description:There is limited high-quality research investigating the efficacy of palliative radiation (PPR) with regard to symptoms and quality of life (QOL) among cancer patients with pelvic soft tissue tumors. As a result, clinicians are left with mainly retrospective studies, without reliable data on which to base treatment decisions. As a first step of a subsequent analysis of PPR's efficacy, we aimed to determine whether it is feasible to prospectively measure symptoms and QOL among patients treated with PPR. A secondary aim was to explore patients' willingness to answer existential questions in the setting of palliative pelvic radiation.Patients referred for palliative radiation of soft-tissue pelvic tumors were invited to enter the study. Symptoms were scored by study physicians and QOL was assessed by the EORTC QLQ C-30 questionnaire and site specific modules (PR25, CR38 or BL24) prior to start of radiation and 6 and 12 weeks after its completion. In addition, patients answered existential questions at each of the study visits. A radiation therapist was available to participants in order to answer their questions and ensure that questionnaires were completed.Five female and 17 male patients with prostate cancer (14), colorectal cancer (5) and bladder cancer (3) were included in the study. The median age of the participants was 75 years (range 62-90). Twenty patients were still in the study at the 6-week follow-up and 18 patients at the 12-week follow-up. Twenty-one patients had valid responses within all the EORTC QLQ C-30 scales at baseline, 20/20 at the 6-week follow-up and at the 12-week follow-up 17/18 patients still in the study had valid responses within all scales. This level of response was similar in the site-specific modules and among the existential questions.Among patients with prostate, colorectal and bladder cancer, compliance to questionnaires assessing symptoms, QOL and existential questions 6 and 12 weeks after PPR is sufficient to enable evaluation in a larger and more homogeneous patient group in order to reach clinically valid conclusions as to the efficacy of PPR.

Dataset Information

Patient reported symptoms associated with quality of life during chemo- or immunotherapy for bladder cancer patients with advanced disease.

Background

Methods

Results

Conclusions

Publications

Patient reported symptoms associated with quality of life during chemo- or immunotherapy for bladder cancer patients with advanced disease.

Similar Datasets

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