scholarly journals Phase III Comparison of Tamoxifen Versus Tamoxifen Plus Ovarian Function Suppression in Premenopausal Women With Node-Negative, Hormone Receptor–Positive Breast Cancer (E-3193, INT-0142): A Trial of the Eastern Cooperative Oncology Group

2014 ◽  
Vol 32 (35) ◽  
pp. 3948-3958 ◽  
Author(s):  
Amye J. Tevaarwerk ◽  
Molin Wang ◽  
Fengmin Zhao ◽  
John H. Fetting ◽  
David Cella ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Premenopausal Women ◽  
Menopausal Symptoms ◽  
Phase Iii ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Purpose The effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS. Patients and Methods Premenopausal women with axillary node-negative, hormone receptor–positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration. Results In all, 345 premenopausal women were enrolled: 171 on tamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P = .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up. Conclusion When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.

Patient-reported outcomes and medication adherence in patients with heart failure

2020 ◽  
Author(s):  
Anne Ankerstjerne Rasmussen ◽  
Henrik Wiggers ◽  
Martin Jensen ◽  
Selina Kikkenborg Berg ◽  
Trine Bernholdt Rasmussen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Related Quality ◽  
Symptoms Of Depression ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Lower Health ◽  
Β Blockers

Abstract Aims Patient-reported outcome measures (PROMs) may predict poor clinical outcome in patients with heart failure (HF). It remains unclear whether PROMs are associated with subsequent adherence to HF medication. We aimed to determine whether health-related quality of life, anxiety, and depression were associated with long-term medication adherence in these patients. Methods and results A national cohort study of Danish patients with HF with 3-year follow-up (n = 1464). PROMs included the EuroQol five-dimensional, five-level questionnaire (EQ-5D-5L), the HeartQoL and the Hospital Anxiety and Depression Scale (HADS). Patient-reported outcomes (PRO) data were linked to demographic and clinical data at baseline, and data on all redeemed prescriptions for angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers/angiotensin receptor neprilysin inhibitors (ACEI/ARB/ARNI), β-blockers, and mineralocorticoid receptor antagonists during follow-up. Medication non-adherence was defined as &lt;80% of proportion of days covered. In adjusted regression analyses, lower health-related quality of life (EQ-5D and HeartQoL) and symptoms of depression (HADS-D) at discharge were associated with non-adherence. After 3 years of follow-up, lower health-related quality of life (EQ-5D) was associated with non-adherence for ACEI/ARB/ARNI [adjusted OR 2.78, 95% confidence interval (CI): 1.19–6.49], β-blockers (adjusted OR 2.35, 95% CI: 1.04–5.29), whereas HADS-D was associated with non-adherence for ACEI/ARB/ARNI (adjusted OR 1.07, 95% CI: 1.03–1.11) and β-blockers (adjusted OR 1.06, 95% CI: 1.02–1.10). Conclusion Lower health-related quality of life and symptoms of depression were associated with non-adherence across HF medications at 1 and 3 years of follow-up. Person-centred care using PROMs may carry a potential for identifying patients at increased risk of future medication non-adherence.

scholarly journals Changes of Health-Related Quality of Life Within the 1st Year After Stroke–Results From a Prospective Stroke Cohort Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Anabelle Kainz ◽  
Christa Meisinger ◽  
Jakob Linseisen ◽  
Inge Kirchberger ◽  
Philipp Zickler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Regression Coefficient ◽  
Modified Rankin Scale ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Introduction: As prospective data on long-term patient-reported outcome measures (PROMs) to assess Health related Quality of Life (HRQoL) after stroke are still scarce, this study examined the long-term course of PROMs and investigated influential factors such as recanalization therapies.Materials and Methods: A total of 945 (mean age 69 years; 56% male) stroke patients were enrolled with a personal interview and chart review performed at index event. One hundred forty (15%) patients received thrombolysis (IVT) and 53 (5%) patients received endovascular therapy (ET) or both treatments as bridging therapy (BT). After 3 and 12 months, a follow-up was conducted using a postal questionnaire including subjective quality of life EQ-5D-5L (European Quality of Life 5 Dimensions). At all time-points, Modified Rankin Scale (mRS) was additionally used to quantify functional stroke severity. Differences between therapy groups were identified using post-hoc-tests. Linear and logistic regression analyses were used to identify predictors of outcomes.Results: Recanalization therapies were associated with significant improvements of NIHSS (National Institutes of Health Stroke Scale [regression coefficient IVT 1.21 (p = 0.01) and ET/BT 7.6; p = 0.001] and mRS (modified Rankin Scale) [regression coefficient IVT 0.83; p = 0.001 and ET/BT 2.0; p = 0.001] between admission and discharge compared to patients with stroke unit therapy only, with a trend toward improvement of EQ-5D after 12 months [regression coefficient 4.67 (p = 0.17)] with IVT. HRQoL was considerably impaired by stroke and increased steadily in 3- and 12-months follow-up in patients with (mean EQ-5D from 56 to 68) and without recanalization therapy (mean EQ-5D from 62 to 68). In severe strokes a major and significant improvement was only detected during period of 3 to 12 months (p = 0.03 in patients with and p = 0.005 in patients without recanalization therapy).Conclusions: Despite significant and continuous improvements after stroke the HRQoL after 12 months remained below the age-matched general population, but was still unexpectedly high in view of the accumulation of permanent disabilities in up to 30% of the patients. Especially in severe strokes, it is important to evaluate HRQoL beyond a 3-months follow-up as improvements became significant only between 3 months and 1 year.

scholarly journals Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma

2016 ◽  
Vol 34 (32) ◽  
pp. 3921-3930 ◽  
Author(s):  
A. Keith Stewart ◽  
Meletios A. Dimopoulos ◽  
Tamás Masszi ◽  
Ivan Špička ◽  
Albert Oriol ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Myeloma ◽  
Minimal Important Difference ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Purpose To determine the effects of carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) on health-related quality of life (HR-QoL) in the Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone for the Treatment of Patients With Relapsed Multiple Myeloma (ASPIRE) trial. Methods Patients with relapsed multiple myeloma were randomly assigned to receive KRd or Rd. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and myeloma-specific module were administered at baseline; day 1 of cycles 3, 6, 12, and 18; and after treatment. The Global Health Status/Quality of Life (GHS/QoL) scale and seven subscales (fatigue, nausea and vomiting, pain, physical functioning, role functioning, disease symptoms, and adverse effects of treatment) were compared between groups using a mixed model for repeated measures. The percentages of responders with ≥ 5- or 15-point GHS/QoL improvement at each cycle were compared between groups. Results Baseline questionnaire compliance was excellent (94.1% of randomly assigned patients). KRd patients had higher GHS/QoL scores versus Rd patients over 18 treatment cycles (two-sided P < .001). The minimal important difference was met at cycle 12 (5.6 points) and approached at cycle 18 (4.8 points). There was no difference between groups for the other prespecified subscales from ASPIRE. A higher proportion of KRd patients met the GHS/QoL responder definition (≥ 5-point improvement) with statistical differences at cycle 12 (KRd v Rd patients, 25.5% v 17.4%, respectively) and 18 (KRd v Rd patients, 24.2% v 12.9%, respectively). Conclusion KRd improves GHS/QoL without negatively affecting patient-reported symptoms when compared with Rd. These data further support the benefit of KRd in patients with relapsed multiple myeloma.

BOLERO-2: Health-related quality-of-life in metastatic breast cancer patients treated with everolimus and exemestane versus exemestane.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 539-539
Author(s):  
J. Thaddeus Beck ◽  
Hope S. Rugo ◽  
Howard A. Burris ◽  
José Baselga ◽  
Shinzaburo Noguchi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

539 Background: BOLERO-2, a phase III study, randomized 724 patients with hormone-receptor–positive metastatic breast cancer, who had recurrence or progression on/after prior nonsteroidal aromatase inhibitor therapy, to everolimus (EVE) plus exemestane (EXE) or EXE and placebo. A preplanned 12-month median time interim analysis demonstrated that EVE+EXE significantly improved progression-free survival (PFS) vs EXE+placebo but that EVE+EXE resulted in a higher rate of grade 3/4 toxicity. Per-protocol patient reported health-related quality-of-life (HRQoL) data are limited; here we report on additional post-hoc analyses of these outcomes. Methods: Using the EORTC–QLQ‑C30 questionnaire, HRQoL was assessed at baseline and every 6 weeks thereafter until progression. The QLQ‑C30 consists of 30 items combined into 15 subscales, including a Global Health Status (GHS) where higher scores (range 0 to 100) indicate better HRQoL. This analysis included a protocol-specified time to definitive deterioration (TTD) analysis at a 5% decrease in QoL relative to baseline, with no subsequent increase above this threshold. We report additional sensitivity analyses using 10-point minimally important difference (MID) decreases in QLQ‑C30 score relative to baseline. Treatment arms were compared using a stratified logrank test and a Cox proportional hazards model adjusted for trial stratum (visceral metastases and previous hormone sensitivity), age, sex, race, baseline score and ECOG performance status, prognostic factors, and treatment history. Results: Baseline QLQ‑C30 GHS scores were not statistically significantly different across treatment groups (64.7 vs 65.3; difference -0.7 [95% CI; -4.3, 3.0]). The median TTD in HRQoL was 7.0 months (95% CI; 5.6, 8.3) for EVE+EXE vs 5.6 (95% CI; 4.2, 7.0) for EXE (P = .0792). Adjusted HR (0.80) approached significance (95% CI; 0.63, 1.02). At the 10-point MID, median TTD for EVE+EXE was 9.7 months (95% CI; 8.3, 11.2) vs 8.4 months (95% CI; 6.3, 12.5) for EXE. Adjusted HR was 0.90 (95% CI; 0.69, 1.18). Conclusions: These additional analyses demonstrate that in addition to significantly improving PFS, EVE+EXE does not compromise HRQoL.

scholarly journals Association of Health-Related Quality of Life with Overall Survival in Older Americans with Kidney Cancer: A Population-Based Cohort Study

Healthcare ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1344
Author(s):  
Naleen Raj Bhandari ◽  
Mohamed H. Kamel ◽  
Erin E. Kent ◽  
Carrie McAdam-Marx ◽  
Songthip T. Ounpraseuth ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Kidney Cancer ◽  
Population Based ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Background: Our purpose was to evaluate associations between health-related quality of life (HRQoL) and overall survival (OS) in a population-based sample of kidney cancer (KC) patients in the US. Methods: We analyzed a longitudinal cohort (n = 188) using the Surveillance, Epidemiology, and End Results (SEER) database linked with the Medicare Health Outcomes Survey (MHOS; 1998–2014). We included KC patients aged ≥65 years, with a completed MHOS during baseline (pre-diagnosis) and another during follow-up (post-diagnosis). We reported HRQoL as physical component summary (PCS) and mental component summary (MCS) scores and OS as number of months from diagnosis to death/end-of-follow-up. Findings were reported as adjusted hazard ratios (aHRs (95% CI)) from Cox Proportional Hazard models. Results: The aHRs associated with a 3-point lower average (baseline and follow-up) or a 3-point within-patient decline (change) in HRQoL with OS were: (a) baseline: PCS (1.08 (1.01–1.16)) and MCS (1.09 (1.01–1.18)); (b) follow-up: PCS (1.21 (1.12–1.31)) and MCS (1.11 (1.04–1.19)); and (c) change: PCS (1.10 (1.02–1.18)) and MCS (1.02 (0.95–1.10)). Conclusions: Reduced HRQoL was associated with worse OS and this association was strongest for post-diagnosis PCS, followed by change in PCS and pre-diagnosis PCS. Findings highlight the prognostic value of HRQoL on OS, emphasize the importance of monitoring PCS in evaluating KC prognosis, and contribute additional evidence to support the implementation of patient-reported outcomes in clinical settings.

Association of Physical Morbidity and Health-Related Quality of Life in a Representative Sample of Older German People

2018 ◽  
Vol 25 (4) ◽  
pp. 140-151
Author(s):  
Markus A. Wirtz ◽  
Matthias Morfeld ◽  
Elmar Brähler ◽  
Andreas Hinz ◽  
Heide Glaesmer
Keyword(s):  
Quality Of Life ◽  
Representative Sample ◽  
Short Form ◽  
Physical Symptoms ◽  
German Population ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Abstract. The association between health-related quality of life (HRQoL; Short-Form Health Survey-12; SF-12) and patient-reported morbidity-related symptoms measured by the Patient Health Questionnaire-15 (PHQ-15) is analyzed in a representative sample of older people in the general German population. Data from 1,659 people aged 60 to 85 years were obtained. Latent class analysis identified six classes of patients, which optimally categorize clusters of physical symptoms the participants reported: musculoskeletal impairments (39.8%), healthy (25.7%), musculoskeletal and respiratory/cardiac impairments (12.8%), musculoskeletal and respiratory impairments, along with bowel and digestion problems (12.9%), general impairments (4.9%), and general impairments with no bowel and digestion problems (4.8%). The participants’ SF-12 Physical Health Scores (η2 = .39) and their Mental Health Scores (η2 = .28) are highly associated with these latent classes. These associations remain virtually identical after controlling for age. The results provide evidence that profiles of patient-reported physical impairments correspond strongly with reduced HRQoL independently from aging processes.

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