Abstract
Background: Patient reported outcome (PRO) assessments, which include quality of life (QoL) and symptoms, have become increasingly important, aiding in identifying and informing patient needs. Patients with acute myeloid leukemia (AML) have poor clinical prognosis and outcomes. There is insufficient knowledge about the impact of disease and treatment on AML patients' lives.
Methods: A multicentre study was performed in the UK to assess PROs in patients with haematological malignancy using a novel hematological malignancy (HM) specific PRO tool, HM-PRO, recently developed for use in daily clinical practice. The HM-PRO is a composite measure consisting of two scales: Part A-measuring the 'impact on patients' quality of life (QoL); and Part B-measuring the effect of 'signs and symptoms' experienced by the patients. Part A consists of domains: physical behaviour (PB), social well-being (SWB), emotional behaviour (EB) and eating and drinking habits (ED). All scales have linear scoring system ranging from 0 to 100, with higher scores representing greater impact on QoL and symptom burden. All data were analyzed by descriptive statistics. Parametric and non-parametric tests at a significance level of P<0.05 were applied as appropriate. Spearman's rank correlation coefficient and regression analysis were performed to investigate the associations between variables. We present the results in a subset of patients with AML.
Results: Thirty-one patients, mean age 61 ± 16 years, 17 males, completed the assessment. Sixteen cases were > 60 years of age. Median time from diagnosis was 261 (IQR 131-790) days. Two cases were at diagnosis, 4 were resistant/refractory, 7 were stable, 15 were in remission (9 still receiving treatment, including stem cell transplantation), and 3 cases were long-term survivors. Ten cases had additional co-morbidities (5 patients in remission). HM-PRO showed good intraclass correlation and Cronbach's alpha > 0.80 in all dimensions (except for social well-being domain which comprised the item "I have problems with my sex life"). Median scores with interquartile ranges were: PB 36 (14-64); SWB 16 (0-33); EB 41 (14-59); ED 25 (25-75); symptom score 22 (17-33). Scale scores were independent of age, gender and comorbidities. PB score was associated with AML status, patients in remission fairing better (p=0.036). The PB item which was most affected was difficulty with physical activities in 77% of cases. EB was affected by 87% worried about future health, 80% worried about being a burden to others; 77% lamenting changes in sleeping pattern, 74% having difficulty concentrating, 67% feeling anxious, 60% worried about dying, 58% about treatment and 42% feeling distressed. ED was strongly associated with the impact of symptoms (p=0.001), with 63% affected by a change of taste so that most patients experienced a change in eating habits. Energy level was compromised (63% mildly, 33% severely) and 52% felt mildly and 38% severely tired. Difficulty with personal relationships present in 23% of cases correlated with distress (r=0.397, p=0.025), anxiety (r=0.471, p=008), lack of confidence (r=0.640, p<0.0001), worry about future health (p=0.357, p=0.042) and difficulty concentrating (r=0.452, p=0.009). Distress correlated with anxiety (r=0.560, p=0.001), fear of dying r=0.563, p=0.001) and worry about treatment (r=0.608, p<0.0001). Sleeping pattern disturbance was significantly correlated with most of the items within EB.
Conclusions: AML has a strong impact on patients' lives. QoL is highly compromised, especially at a physical and emotional level, and seems to be independent of age, gender and comorbidities. Worry and anxiety are prevalent conditions. HM-PRO is a useful tool in clinical practice to identify relevant issues which should be considered during decision-making and addressed to individualize care of AML patients.
Disclosures
Oliva: La Jolla: Consultancy; Janssen: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Celgene: Consultancy, Other: Royalties, Speakers Bureau; Sanofi: Consultancy, Speakers Bureau. Ionova:Takeda: Research Funding; BMS: Research Funding.
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