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Journal of Pain and Symptom Management 1

Original Article

Breathlessness, Functional Status, Distress, and Palliative Care Needs Over Time in Patients With Advanced Chronic Obstructive Pulmonary Disease or Lung Cancer: A Cohort Study Vera Weingaertner, Dipl Ges Oek, Christine Scheve, Dipl Pflegew, Verena Gerdes, Dipl P€ad, Michael Schwarz-Eywill, MD, Regina Prenzel, MD, Claudia Bausewein, PhD, MD, MSc, Irene J. Higginson, BM, BS, BMedSci, PhD, FFPHM, FRCP, Raymond Voltz, MD, Lena Herich, Dr Rer Pol, and Steffen T. Simon, MD, MSc, on behalf of the PAALiativ Project Department of Palliative Medicine, Clinical Trials Unit (BMBF 01KN1106), and Centre for Integrated Oncology Cologne/Bonn (CIO) (V.W., R.V., S.T.S.) and Institute of Medical Statistics, Informatics and Epidemiology (L.H.), University Hospital of Cologne, Cologne; Institute of Palliative Care (BMBF 16KT0951) (V.W., C.S., V.G., C.B., S.T.S.), Oldenburg; Department of Palliative Medicine (M.S.-E.), Protestant Hospital Oldenburg, Oldenburg; Clinic for Internal Medicine (R.P.), Pius-Hospital Oldenburg, Oldenburg; Department for Palliative Medicine (C.B.), University Hospital Munich, Munich, Germany; and Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation-WHO Collaborating Centre for Palliative Care and Older People (I.J.H.), King’s College London, London, United Kingdom

Abstract Context. Breathlessness is a distressing symptom in advanced disease. Understanding its patterns, burden, and palliative care (PC) needs over time is important to improve patients’ quality of life. Objectives. To describe and compare the courses of refractory breathlessness, functional status, distress, and PC needs in patients with advanced chronic obstructive pulmonary disease (COPD) or lung cancer (LC) over time. Methods. This was a cohort study of patients with COPD (Stage III/IV) or LC. Data were assessed monthly with up to 12 telephone interviews, using the modified Borg Scale, Karnofsky Performance Status Scale, Distress Thermometer, and Palliative care Outcome Scale as outcomes measures. Descriptive analysis compared all outcomes between COPD and LC at baseline and over time (forward from study entry and backward from death).

Address correspondence to: Steffen T. Simon, MD, MSc, Department of Palliative Medicine, University Hospital of Cologne, Kerpener Strasse 62, 50924 Cologne, Germany. E-mail: [email protected] Ó 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Accepted for publication: November 21, 2013.

0885-3924/$ - see front matter http://dx.doi.org/10.1016/j.jpainsymman.2013.11.011

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Results. A total of 82 patients (50 COPD and 32 LC), mean (SD) age of 67.2 (7.8), and 36% female were included (8 COPD and 23 LC deceased). The patients with COPD perceived higher levels of breathlessness and distress at lower functional status steadily over time. The LC patients’ breathlessness, distress, and PC needs increased, whereas functional status decreased toward death. The PC needs were similar between disease groups. Breathlessness was negatively correlated with functional status (COPD ¼ mean r ¼ 0.20, P ¼ 0.012; LC ¼ mean r ¼ 0.277, P ¼ 0.029) and positively correlated with PC needs in COPD patients (mean r ¼ 0.343, P < 0.001). Death was significantly predicted by diagnosis (LC: hazard ratio ¼ 7.84, P < 0.001) and functional status (10% decline: hazard ratio ¼ 1.52, P ¼ 0.001). Conclusion. The PC needs of patients with advanced COPD are comparable with LC patients, and breathlessness severity and distress are even higher. The care for COPD patients requires further improvement to address symptom burden and PC needs. J Pain Symptom Manage 2014;-:-e-. Ó 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Key Words Dyspnea, functional status, distress, needs assessment, palliative care, chronic obstructive pulmonary disease, lung cancer, cohort study

Introduction Symptoms such as pain, breathlessness, or nausea are common in patients with lifelimiting diseases and can have a substantial impact on functional status and quality of life.1e4 Previous research examining the prevalence and impact of symptoms in palliative care (PC) settings has predominantly focused on patients with cancer. However, awareness of the high symptom burden and PC needs of patients with life-limiting noncancer diseases, especially chronic obstructive pulmonary disease (COPD), is growing, as recent data suggest that symptom burden and negative impact on quality of life associated with COPD are similar to and perhaps greater than those associated with cancer.5 The need for a PC approach for this population has become more and more evident.5e8 The COPD is highly prevalent worldwide, causing major morbidity and impact on quality of life when associated with somatic symptoms, distress, and loss of function.9e11 Breathlessness (dyspnea, shortness of breath, or difficult breathing) is a common, complex, and distressing symptom in advanced diseases and is probably the most dominant symptom in COPD and also common in lung cancer (LC), with prevalence increasing up to 94% in advanced COPD and 70% in LC.1,9,12,13 Breathlessness is defined as ‘‘a subjective experience of breathing discomfort

that consists of qualitatively distinct sensations that vary in intensity. Experience derives from interactions among multiple physiological, psychological, social and environmental factors and may induce secondary physiological and behavioral responses.’’14 Breathlessness is considered refractory when it persists despite optimal treatment of the underlying condition; it may occur as continuous (breathless all the time) or episodic breathlessness.15e17 Understanding the patterns of breathlessness, functional performance, distress, and PC needs over time is important to provide needsbased care and to improve quality of life for all people living with life-limiting diseases toward the end of life. Results of a previous observational study assessing breathlessness in cancer compared with COPD patients suggested that trajectories differ between the disease groups and, moreover, between population and individual levels.18 However, the time frame of observation was limited to six months; additional information on the impact and PC needs of patients over time is warranted. The present cohort study was initiated to fill this gap. The primary objective of this study was to describe and compare the courses of refractory breathlessness in patients with advanced COPD or LC over time. The secondary objective was to explore the relationships

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of breathlessness, functional status, distress, and PC needs over time.

Methods Study Design This was a prospective, longitudinal cohort study of explorative intent. Ethical approval was obtained from the State Medical Chamber of Lower Saxony, Hannover, Germany (Bo/ 20/2009).

Participants German-speaking patients aged 18 years or older with COPD Stage III or IV (GOLD classification), or primary LC (small-cell LC or none small-cell LC) at any stage were eligible to participate. Exclusion criteria were unwillingness or inability to provide written informed consent, poor physical condition (not allowing assessment), and cognitive impairment (as judged by the recruiting physician). Participants were recruited from two inpatient units and two outpatient clinics in Oldenburg, Germany, by the treating physician from February 2010 to April 2011. Patients willing to participate were contacted by a study nurse, who provided detailed information on the study procedures and obtained written informed consent.

Data Collection Data were collected at study entry (structured face-to-face interview at baseline) and then monthly (4  2 weeks) by up to 13 structured follow-up telephone interviews (FUp) as this was considered to be the most efficient and feasible collection method over time.19 The initial telephone interview (0-FUp) was part of the baseline assessment conducted shortly (less than 2 weeks) after the face-to-face interview. To maintain comparability of collection time points (FUps), patients unavailable for more than six weeks from the previous FUp were excluded. Baseline data included sociodemographic and clinical details (details of diagnosis, spirometry, medication, functional status, and comorbidities [Charlson Comorbidity Index20). Data were collected by two trained researchers.

Measures The following patient-reported outcome measures were assessed at each FUp. Breathlessness

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severity was described using the modified Borg Scale: 1) at the moment of interview, 2) at exertion, 3) at rest, 4) at its maximum, and 5) on average over the last 24 hours. These data were used to describe breathlessness severity at baseline. During FUp, breathlessness severity was assessed by ‘‘average over the last 24 hours,’’ which has been recommended as a valid outcome measure for research.21 The modified Borg Scale is a categorical scale of 0 ¼ no breathlessness to 10 ¼ maximal breathlessness, with values of five or higher indicating severe-to-very severe breathlessness; it has been considered adequate as a ratio scale for statistical calculations.22,23 Functional status was assessed by the Karnofsky Performance Status (KPS) Scale.24 Distress was measured on the National Comprehensive Cancer Network Distress Thermometer (German version), a numerical rating scale (zero to 10) with scores of four or higher indicating levels of distress that have clinical significance.25,26 The Palliative care Outcome Scale (POS) was used to assess the PC needs, including 10 items rated on a categorical scale of zero (no) to four (overwhelming problem): pain control, symptom control, patient anxiety, family anxiety, information, sharing feelings, depression, selfworth, practical needs, and time wasted.27 Time of death was documented for all study participants until September 5, 2012. Data were subsequently entered in a person-period data set using EpiData 3.1 (The EpiData Association, Odense, Denmark), which provides programmed data entry and automatic error detection features.28 All data were checked for correctness by a second researcher. The primary data set was transferred to MS Excel 2003 for data cleaning (check of relevant missing data; check and correction of implausible data, e.g., interview dates, clinical data, and correct spelling of all IDs) and completion of dropout and survival data (reason for dropout, date of death, days included in the study, days between death and last assessment, and so on). Two patients with a delay of more than two weeks between baseline and initial telephone assessment (because of bad health) were included because of their high willingness to participate. Study entry, therefore, was defined by date of first reassessment of demographic data in one and by date of first FUp interview in the second, as demographic data were not reassessed.

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Statistical Analysis Only breathless patients were included in the analysis, defined as ratings of higher than zero on the modified Borg Scale at least once during the study. The outcomes of interest in this study were breathlessness severity over the last 24 hours, functional status, distress, and PC needs. A descriptive analysis was conducted for baseline and longitudinal data (percentages, means, SD, 95% CI, medians, and ranges), comparing all outcomes between the disease groups at every consecutive time point. To test for differences, independent t-tests or Mann-Whitney U tests were used if continuous data were approximately normally distributed or not normally distributed, respectively. Categorical data were compared using the Chi-squared test or Fisher’s exact test, as appropriate. Survival curves for both conditions were plotted using the Kaplan-Meier method and compared by log-rank test. Patients who were still alive at the cutpoint date were grouped as alive. If information on survival status was missing, patients were grouped as alive for the Kaplan-Meier analysis and were censored at the last known date alive (last FUp interview date). Univariate Cox regression analyses with time-dependent co-variables (breathlessness over the last 24 hours, KPS score, total POS score, and distress) were conducted to investigate the relationship between outcome measures and survival. Additionally, the effect of the co-variables, namely age, sex, and diagnosis on survival was investigated. Subsequently, all parameters were included in a multiple Cox regression model (with backward stepwise selection). Hazard ratios (HRs), two-sided 95% CIs, and P-values are reported. Longitudinal data were analyzed forward from study entry (0-FUp) for all participants. Backward analysis from death was conducted for decedents providing any data within their last 12 months of life. To explore the course of breathlessness in relation to the other outcomes by disease group over time, mean values per FUp were plotted on a scale of zero to 10 (KPS and POS total score linearly transformed). The relationship between breathlessness and the other outcomes was explored using correlation analysis: first, bivariate correlation coefficients (r) were calculated for each patient over each point of measurement; second, means of these values were

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computed for the whole population and separately for COPD and LC patients. One-sample ttests were used to test the difference of these mean values vs. zero. Because the analysis was of descriptive rather than confirmatory character, the level of significance was set at P-value lower than 0.05 and was two sided. Data analysis was performed using SPSS Statistical Software for Windows, v. 21 (SPSS, Inc., IBM Corp., Armonk, NY) and Stata/SE version 12.0 (StataCorp LP, College Station, TX).

Results Study Population A total of 82 patients (50 COPD and 32 LC) suffering from breathlessness at least once during data collection were included in the analysis (Table 1). A total of 34 patients (41.5%, 26 COPD and 8 LC) completed maximum data collection of 13 interviews, 13 patients (3 COPD and 10 LC) died during the study, and 35 patients (21 COPD and 14 LC) did not finish the 12 month period of data collection. Reasons for dropout were: unavailable for more than six weeks (n ¼ 13), worsening of medical condition and/or hospital stay (n ¼ 15), loss of interest (n ¼ 4), death or illness of relatives (n ¼ 2), or ‘‘feeling too healthy’’ (n ¼ 1). Median study duration tended to be longer in COPD than LC patients (178 days [range 1e393] vs. 151 days [range 0e386], P ¼ 0.071).

Outcomes at Baseline At baseline, 72 patients (48 COPD and 24 LC) were breathless (Table 2). The percentage of patients who complained about breathlessness was higher in the COPD group (P ¼ 0.005) and this group reported continuous breathlessness more often (P ¼ 0.007). Moreover, COPD patients perceived significantly higher breathlessness severity in all five situations assessed except for ‘‘at rest,’’ for which there was still a trend. The proportion of patients suffering from severe-to-very severe breathlessness over the last 24 hours was three times higher in COPD than in LC patients (P ¼ 0.018). The patients with COPD had a slightly more limited functional status (P ¼ 0.007). In both groups, more than 70% of the patients scored clinically meaningful levels of distress. The PC needs were similar in both groups at baseline, with

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Table 1 Patient Characteristics Characteristics Sociodemographic details Age, y, mean (SD, range) Female Marital status Married Single Divorced/widowed Smoking (MD ¼ 2) Never Former Still Clinical characteristics CCI, median (range) KPS, mean (SD, range) Supplemental oxygen Disease-Specific Details

Total, n (%)

COPD, n (%)

LC, n (%)

82 (100)

50 (100)

32 (100)

67.2 (7.8, 45e85) 30 (37)

67.7 (7.6, 51e85) 21 (42)

66.4 (8.2, 45e83) 9 (28)

Difference (P-value) 0.472 0.203

60 (73) 2 (2) 20 (25)

39 (78) 1 (2) 10 (20)

21 (66) 1 (3) 10 (31)

0.449

7 (9) 63 (77) 10 (12)

3 (6) 39 (78) 8 (16)

4 (13) 24 (75) 2 (6)

0.317

1.0 (0e11) 73.5 (14.9, 30e90) 31 (38)

1.0 (0e10) 69.4 (14.3, 30e90) 27 (54) COPD GOLD III IV FEV1 %

n (%) 20 (40) 30 (60) Mean (SD) 32.1 (11.6)

2.0 (0e11) 80.0 (13.7, 40e90) 4 (13) LCa TNM n (%) IIIa 4 (13) IIIb 3 (9) IV 22 (69) MD 3 (9) n Metastasesb Lymph node 11 Pulmonary 15 Cerebral 4 Liver 4 Bone 13 Pleura 5

0.150 0.001

Breathlessness, functional status, distress, and palliative care needs over time in patients with advanced chronic obstructive pulmonary disease or lung cancer: a cohort study.

Breathlessness is a distressing symptom in advanced disease. Understanding its patterns, burden, and palliative care (PC) needs over time is important...
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