Journal of Pain and Symptom Management
Volume 40, Issue 5 , Pages 652-660, November 2010

Effectiveness of Palliative Care Services in Symptom Control of Patients with Advanced Terminal Cancer: A Spanish, Multicenter, Prospective, Quasi-Experimental, Pre-Post Study

  • Xavier Gómez-Batiste, MD, PhD

      Affiliations

    • World Health Organization Collaborating Center for Public Health Palliative Care Programs, Catalan Institute of Oncology, Barcelona, Spain
    • Corresponding Author InformationAddress correspondence to: Xavier Gómez-Batiste, MD, PhD, Catalan Institute of Oncology, WHO Collaborating Center for Palliative Care Public Health Programs, Av. Gran Via 199, 08907 L'Hospitalet, Barcelona, Spain.
    • ,
  • Josep Porta-Sales, MD, PhD

      Affiliations

    • Palliative Care Service, Catalan Institute of Oncology, Barcelona, Spain
    • ,
  • Jose Espinosa-Rojas, MD

      Affiliations

    • World Health Organization Collaborating Center for Public Health Palliative Care Programs, Catalan Institute of Oncology, Barcelona, Spain
    • ,
  • Antonio Pascual-López, MD, PhD

      Affiliations

    • National Strategy for Palliative Care, Agency for Quality, Ministry of Health, Madrid, Spain
    • ,
  • Albert Tuca, MD

      Affiliations

    • Palliative Care Service, Catalan Institute of Oncology, Barcelona, Spain
    • ,
  • José Rodriguez, RN

      Affiliations

    • National Strategy for Palliative Care, Agency for Quality, Ministry of Health, Madrid, Spain

Accepted 22 February 2010. published online 27 August 2010.

Article Outline

Abstract 

Context

In implementing the National Strategy of Palliative Care in Spain, there needs to be an evaluation of services, especially of their effectiveness, efficiency, and satisfaction of patients and families.

Objectives

To assess the effectiveness of palliative care services (PCS) in improving symptom control in Spain.

Methods

This multicenter, prospective, quasi-experimental, pre-post intervention study evaluated symptoms, such as pain, breakthrough pain, anorexia, nausea/vomiting, constipation, insomnia, dyspnea at rest and with movement, anxiety, and depression, using patient-reported numeric rating scales on Days 0, 7, and 14 after referral to a PCS.

Results

Of the 318 PCSs included in the National Directory for 2004, 105 services in the 17 autonomous regions of Spain were able to report 265 eligible (treatment-naïve) patients. Nonparticipation by some centers was because of excessive workload or because their patients were not treatment-naïve. Median survival was 42 days. Pain severity and number of crises of breakthrough pain significantly improved, as did other indicators of patient satisfaction. Symptom improvement was independent of type of service (in acute bed hospitals, medium-term stay facilities, hospital support teams, home care support teams, and outpatient clinics).

Conclusion

Our national plan appears to be successful in reducing symptoms irrespective of the type of organization providing the PCS. An area for improvement could be to lessen the workload of individual teams.

Key Words: Palliative care services, cancer pain, symptom control, effectiveness, clinical outcomes

 

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Introduction 

A rapid implementation of palliative care services (PCSs) has taken place in Spain over the past 15 years.1 The efficiency of these services has been assessed in two main studies in terms of overall numbers2 or with respect to home care support teams (HCSTs) in Catalonia.3 Other individual programs have been evaluated as well.4, 5 The effectiveness and efficiency of PCSs have been suggested in meta-analyses,6 and the consensus is that effectiveness is the key outcome that remains to be clearly demonstrated.7

Several multidimensional scales have been developed and validated to measure the clinical outcomes in patients and the effects on their families. Simple symptom scales, routinely used in daily clinical practice, have been found to be valid and reproducible in measuring changes in symptom control in different settings, including palliative care units (PCUs), home care settings,8 and outpatient clinics (OCs).9 Usually, the tools used are a set (or a list) of symptoms measured using a visual analog scale (VAS) or a numerical rating scale.10, 11, 12 At the Catalan Institute of Oncology, we have been using, for several years, a shortened form of a numerical verbal scale (NVS), which assesses pain, anorexia, constipation, insomnia, anxiety, and depression. An extended version of the NVS includes breakthrough pain, nausea and vomiting, and dyspnea.9 Most PCSs in our country use the simple, or the extended, NVS in daily clinical practice to assess and monitor symptom control.

Previous studies covering different aspects of care have shown that the involvement of PCSs has been acceptable, feasible, and successful as a methodology in a multicenter format for the recruitment of patients for assessment and maintaining a degree of homogeneity so that findings can be generalized.13, 14, 15, 16 These studies are quasi-experimental. In a previous pilot study, for example, performed to evaluate effectiveness of symptom control in 111 PCSs in Catalonia, a clinically relevant decrease in symptom intensity was observed. Apart from methodological constraints, it is ethically questionable to use other more complex methodologies, such as randomized controlled trials, especially in multicenter studies of pain management.17

There is a growing requirement to evaluate, using different models,18, 19 the clinical and organizational outcomes of PCSs, especially with respect to effectiveness, efficiency, and patient satisfaction. In Spain, the rapid development of PCSs and the National Strategy of Palliative Care (Estrategia Nacional de Cuidados Paliativos [ENCP])20 have highlighted the increasing need to evaluate the effectiveness of PCSs. The aim of the present multicenter study was to assess the effectiveness of Spanish PCSs in improving symptom control in patients with advanced cancer, evaluate some of the clinical outcomes with a simple feasible methodology, and promote the cooperation among the PCSs within the context of the ENCP being implemented by the Ministry of Health in most regions of Spain.

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Methods 

Design 

The study was a multicenter, quasi-experimental, pre-post study of advanced cancer patients admitted for the first time to a PCS in Spain. The severity of eight symptoms was assessed on Days 0, 7, and 14.

Patient Population 

Consecutive patients with advanced or terminal cancer, not receiving anticancer therapy, who were admitted into a PCS in Spain between February and May 2007, were selected for the study. Inclusion criteria were advanced cancer, >18 years of age, not receiving chemotherapy or radiotherapy in the previous 30 days, attending a PCS for the first time, and facility for contact by telephone. Informed consent and ethics committee approval were obtained at each study center. The severity of pain (basal and breakthrough) and other prevalent symptoms (including anorexia, nausea/vomiting, constipation, insomnia, anxiety, depression, and dyspnea) were assessed at each PCS for a period of 14 days after starting the intervention.

Services 

All 318 PCSs registered in the Sociedad Española de Cuidados Paliativos (SECPAL) 2004 Directory were invited to participate. They were categorized as PCUs in acute bed hospitals, or in other facilities, hospital support teams (HSTs), HCSTs, and OCs. Each team of investigators included health care providers (clinical and nonclinical) and a coordinator for each autonomous region of Spain.

Methods 

Every team (doctor or nurse) recruited eligible patients in a period of five consecutive days. Symptom intensity was assessed on admission (T0) and, subsequently, at 7 and 14 days after admission (T7 and T14, respectively). Date of death also was recorded. The following parameters were recorded: age, gender, Karnofsky Performance Status score, cognitive impairment, and Edmonton Staging System score.10

Symptom severity in the previous 24 hours was assessed by NVS for breakthrough pain (severity and number of crises), anorexia, nausea/vomiting, constipation, insomnia, dyspnea at rest, dyspnea on movement, anxiety, and depression. The choice of these symptoms for evaluation was based on our previous OC experience, which provided a sufficiently detailed but easily acquired picture of symptom burden representing the different dimensions of needs, as defined by the European Association for Palliative Care21 and its Spanish version.22 Pain and other symptoms were considered as “well controlled” if the NVS was ≤4 in 10 categories.23

Statistical Analyses 

The cases that were not evaluable because of withdrawal or other reasons are, nevertheless, reported in the analyses. Type of population attended to by the palliative health care teams was described in terms of the types of variables, the categorical or dichotomous variables calculated as absolute frequencies and relative frequencies, accompanied by the corresponding confidence interval (CI). The continuous variables were described using the central value calculation, mean or median, and the range or 95% CI.

Overall survival was defined as the time lapse between the day of the first clinical visit and death or the last monitoring visit in case death did not occur within the timescale of the study. The analyses were performed in all evaluable patients using the Kaplan-Meier method. The 95% CI values were derived using actuarial methods. To demonstrate the principal objective (evaluation of patients' symptom control), the Wilcoxon signed-rank test for related samples was applied for paired variables. All the tests were two-tailed, with a standard error of 5%. The results are presented as overall values and stratified for health care resources used (home care, hospital, HST, OC).

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Results 

Participation of Services 

Of the 318 services registered in the SECPAL 2004 Directory that were asked to participate, 223 (70.1%) accepted, but only 105 (33.1%) were able to recruit evaluable patients. The services that took part in the study were from all the 19 Spanish autonomous regions. The highest number of participating centers was 36 (34%) from Catalonia (because this is the region with the most highly developed National Health System [NHS]/PCS system), 14 (13%) from Andalucia, 10 (9%) from Valencia, and 45 (44%) from other regions of Spain. The main reason given by the PCSs for choosing not to participate was excessive clinical workload. The main reason for not recruiting patients into the study was because the patients were not treatment-naïve when seen by the specialist investigation team. There were no systematic differences between PCS sites that contributed patients to the study and those that did not.

Patients 

There were 265 patients included in the study. The distribution by type of service is shown in Table 1. Sociodemographic and clinical characteristics (including Edmonton Pain Staging) of patients are described in Table 2, Table 3. Assessments were completed in 203 (76.6%) patients. The reasons for dropout were death or severe impairment in 69.4% and 22.5% of patients, respectively. The median survival was 42 days (95% CI: 34–50), with no statistically significant differences in patient survival segregated with respect to the different types of service providing the palliative care (P=0.753).

Table 1. Distribution of Patients by Type of PCU Providing the Service
Service Typen%
PCU hospital03714.0
HST03914.7
PCU social health center02910.9
OCs00200.8
HCST15859.6

Total265100.0
Table 2. Demographic and Selected Clinical Characteristics of the Patients
Characteristicn (%)
Gender, male/female162 (61.1)/103 (38.9)
Age, years (mean [range])72.2 (35–98)

Primary cancer sitesa
Lung60 (22.6)
Colorectal41 (15.5)
Hepatobiliary23 (8.7)
Pancreas21 (7.9)
Breast19 (7.2)
Stomach17 (6.4)
Prostate17 (6.4)
Urinary tract13 (4.9)
Genital (female)10 (3.7)
Head and neck9 (3.4)

Cognitive status
Impaired161 (60.8)
Intact66 (24.9)
Moderate33 (12.5)
Severe3 (1.1)
Nonevaluable2 (0.8)

Functional status (KPS)
10–3030 (11.3)
40–50128 (48.5)
60–7081 (30.6)
80–10023 (87)
Missing data3 (1.1)

Edmonton Staging System
No pain46 (17.6)
Stage I94 (35.5)
Stage II70 (26.4)
Stage III52 (19.6)
Missing data3 (1.1)

KPS=Karnofsky Performance Status.

a10 most prevalent.

Table 3. Prevalence of Symptoms at the First Assessment
SymptomEvaluable Patients, nPrevalence
n%
Pain20212662.4
Breakthrough pain24919277.1
Anorexia26019876.2
Nausea/vomiting2599436.3
Constipation26215358.4
Insomnia25516464.3
Dyspnea at rest2627327.9
Dyspnea on movement25211352.8
Anxiety26217165.3
Depression26016262.3

A significant improvement in pain intensity was observed, especially seven days after starting palliative care, and continuing up to the 14th day assessment (Table 4; Fig. 1). With respect to breakthrough pain, the daily number of crises improved significantly on the 7th and 14th day, from a mean severity of the crisis of 2.7–1.5 (7th day) and 1.2 (14th day) (P<0.0001) (Fig. 2).

Table 4. Pain Control
Type of PainNumber of Evaluable Patients naDay 0Day 7Day 14P
NRS≤4, n (%)NRS>4, n (%)NRS≤4, n (%)NRS>4, n (%)NRS≤4, n (%)NRS>4, n (%)
Background painb202141 (69.8)61 (30.2)183 (90.6)19 (9.4)187 (92.6)15 (7.4)0.0001d
0.28e
Breakthrough painc19591 (46.7)104 (53.3)125 (64.1)70 (35.9)144 (73.8)51 (26.2)0.0001d
0.001e

NRS=numerical rating scale.

aNumber of patients assessed in the three evaluations.

bPain in the previous 24 hours.

cGlobal perception (severity and number of crises) of breakthrough pain.

dStatistically significant comparing Day 0 vs. Day 7.

eStatistically significant comparing Day 7 vs. Day 14.

All symptoms that had been assessed improved significantly from Day 0 to Day 7 and from Day 0 to Day 14. Also, constipation, anxiety, and depression improved significantly between Days 7 and 14 (Table 5).

Table 5. Control of Symptoms Other Than Pain
SymptomNumber of Evaluable Patients naDay 0Day 7Day 14P
NRS≤4, n (%)NRS>4, n (%)NRS≤4, n (%)NRS>4, n (%)NRS≤4, n (%)NRS>4, n (%)
Anorexia18995 (50.3)95 (49.7)127 (67.2)62 (32.8)130 (68.8)59 (31.2)<0.0001b
0.57c
Nausea/vomiting170149 (87.6)21 (12.4)163 (95.9)7 (4.1)165 (97.1)5 (2.9)0.001b
0.15c
Constipation199131 (65.8)68 (34.2)166 (83.4)33 (16.6)183 (92)16 (8)<0.0001b
0.001c
Insomnia196127 (64.8)69 (35.2)162 (82.7)34 (17.3)170 (86.7)26 (13.3)<0.0001b
0.11c
Dyspnea at rest169147 (87)22 (13)158 (93.6)11 (5.5)161 (95.3)8 (4.7)0.007b
0.54c
Dyspnea on movement16798 (58.7)68 (41.3)118 (70.7)49 (29.3)126 (75.4)41 (24.6)<0.0001b
0.1c
Anxiety186110 (59.1)76 (40.9)147 (79)39 (21)157 (84.4)29 (15.6)<0.0001b
0.025c
Depression181109 (60.9)70 (39.1)129 (71.3)52 (28.7)139 (76.8)42 (23.2)0.001b
0.012c

NRS=numerical rating scale.

aNumber of patients fulfilling the three scheduled assessments.

bSignificance between Days 0 and 7.

cSignificance between Days 7 and 14.

No differences were observed in symptom control between the different modalities providing palliative care (PCUs, HCSTs, and HSTs).

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Discussion 

Participating Services 

The main reason given by the PCSs for not participating was excessive workload. The main reason for not being able to recruit patients (118 services), despite being willing to participate, was that the patient was already receiving care from other teams; >50% of palliative care patients in Spain receive attention from more than one team.2

Patients in the Study 

The 265 patients included in the current analysis were sufficient to analyze effectiveness of the PCSs. The characteristics of the sample of patients predominantly show advanced terminal illness with a very short survival time. The type and frequency of symptoms were similar to other patient series in our experience.24

Symptoms Assessed and the Scales Used 

We used a set of eight symptoms commonly applied in our clinical practice over many years.9 The selection of these symptoms was based on their high prevalence, the feasibility of modifying them with treatment, and their impact on the patients.25 Also, we proposed this methodology to encourage participation and increase the feasibility of conducting the study within the context of a large, national, multicenter program involving many teams.

Symptom Control 

Comparing T0 with T14, there was a significant decrease in the severity of all symptoms, as well as in the number and severity of breakthrough pain crises, in all the settings considered. The most significant reduction in pain and symptom intensity was evident after one week (Day 7) of palliative care implementation, and this reduction was maintained in the subsequent assessment (Day 14).

Improvement in symptom control was noted in all the patient care settings, with no significant differences among types of services. This implies that every service implemented measures to improve symptom control and achieved more or less similar results.

Our previous pilot study in Catalonia with 111 services of different types and settings had included a total number of 159 patients with advanced and terminal cancer. The pattern of illness was similar. Variables, such as length of survival, being treatment-naïve in PCSs, pain severity, breakthrough pain, weakness, anxiety, and insomnia, were recorded using numerical scales on the first day of treatment and seven days later. The results showed a significant improvement in all the symptoms recorded, including a significant improvement in the weakness variable. The present study included more symptoms for evaluation and more services representative of the different regions throughout Spain.

Several studies have analyzed the effectiveness of palliative interventions in hospitals,26 OCs,9 and long-term institutionalized care27 using the Edmonton Symptom Assessment System scale. Modonesi et al.28 assessed the severity of symptoms at the time of the patients admission to the PCU and over the next seven days in patients with a similar survival time. Within one week, significant reductions were observed with respect to pain, anorexia, nausea, and anxiety; there also was a statistically nonsignificant improvement in depression. The only symptom with worsening severity was somnolence, a symptom that was not analyzed in our study. The most significant improvements in severity were shown by symptoms that had previously had the highest scores (5–10 on the VAS).

A recent Phase II study carried out in 123 outpatients with metastatic cancer29 showed significant reductions in pain, nausea, dyspnea, insomnia, anxiety, and depression after a week of intervention; these outcomes were maintained at four weeks postintervention. The percentage of patients with reductions of >1 point on the VAS scale ranged between 35% and 46%.

The prevalence of pain in cancer is related to its disease stage, increasing from 36% in early stages up to nearly 80% at end-stage disease.30 In our series, 64% of patients reported the presence of pain, one-third of them with moderate or severe intensity. With respect to its management and according to the results obtained in the World Health Organization cancer pain relief ladder validation, relief can be expected in as many as 80% of patients after the first week of treatment.31 Other authors, however, have found evidence of lower relief rates (45%).32 In our series, we obtained a relief rate of 90% after the first week, and this was sustained over the two weeks of the study.

Of considerable note is that, despite many patients being considered as having had a bad pain prognosis, pain control was achieved in most patients. At the time of the present study, the Edmonton Classification System for Cancer Pain as a prognosis scale had been published and validated,10 but most of our participating teams seldom used it. The preference, in terms of feasibility and comparison, was the well-documented Edmonton Staging System.33

Breakthrough pain was highly prevalent in our sample (77.1%), as in other reports,34 and higher than our previous pilot study (41%). Although it is not possible to compare effectiveness of the different drugs or other measures used by the palliative care teams for the alleviation of the breakthrough pain episodes, the overall improvement in this variable is remarkable. By the second week, only 26.2% of the patients had moderate-severe episodes of pain, and the mean number of episodes was <2.

Anorexia is one of the most challenging symptoms in the very advanced cancer patient population; its frequency ranges between 26% and 92%.35 As expected, we found a high frequency (77.1%) of anorexia at the first clinical visit. Almost half of the patients reported moderate-severe anorexia at entry into the study, and one-third of them had anorexia one week after the initial assessment. Current treatment relies on the use of corticosteroids, megestrol acetate, and nutritional support/advice.36

Nausea and vomiting occurs in between 6% and 37% of advanced cancer patients.37 Approximately one-third of the patients in our study complained of nausea or vomiting when initially assessed. There followed a rapid and steady alleviation of this symptom, with only 2.9% of patients recording nausea/vomiting with a score >4 on the NVS after two weeks of treatment. The efficacy of treatment, mainly based on pharmacological intervention, the choice of which was left to the attending physician, varied widely. Noncontrolled trials have shown responses of 75%–93% for both nausea and vomiting.

Constipation is a well-documented and distressing problem in advanced cancer patients, with prevalence ranging from 23% to 65%.38 The prevalence in our population was 58.4%. Various laxatives, singly or in combination, usually offer improvement in 60%–75% of patients.39 The most recently launched opioid antagonist (methylnaltrexone) appears to be more effective40 but was not available when our study was carried out. We found a continuous improvement in the constipation symptom during the assessment period, with 92% of patients showing improvement of ≤4 on an NVS of 0–10.

Prevalence of dyspnea ranges between 14% and 39% in advanced cancer patients.41 In our sample, dyspnea at rest was recorded in 27.9% of patients, with 13% scoring ≥4. As expected, dyspnea on exertion was more frequent (52.8%), with improvement rates being lower than dyspnea at rest. A multimodal approach is warranted for the alleviation of dyspnea, using pharmacological and nonpharmacological treatments.42

Insomnia is a very frequent problem in advanced cancer patients, with 50% recording poor sleep patterns.38 In our study, 64.3% of patients complained of insomnia, and 35.2% scored ≥4 for this symptom at the first clinical visit. Scoring improved significantly after one week. Benzodiazepines, administered for short periods (6–9 days), have produced >80% improvement in insomnia.43 This finding could be related to depression and anxiety, both of which show improvement after the first week.

With respect to the prevalence of mental disorders in cancer patients, a recent European survey38 showed moderate-to-severe anxiety (28%) and depression (18%) in a sample of 3030 patients with advanced cancer. In our study, about two-thirds of patients presented some kind of anxiety or depression, with 40% scoring ≥4 on an NVS of 0–10. The positive, and significant, improvement of the emotional distress over time (14 days) should be seen as the result of the integrated multidisciplinary intervention of the palliative care team that addresses the alleviation of the somatic symptoms and provides a psychopharmacological approach to the illness.44

The dropout rate of this study is consistent with the characteristics of the patient sample. Therefore, we consider these results as the first detailed global evaluation of the effectiveness of the recently implemented Spanish National Plan.

Limitations of the Study 

The principal limitation of the study was that 105 services may not be truly representative of the whole country. This could imply a sample bias. On the other hand, with more than half of the existing PCSs in Spain being represented, this multicenter study can be considered a good outcome for an initial collaboration on a national scale. This could be the basis for further surveys with larger numbers of patients. Another possible limitation is that of the pattern of symptoms chosen for the evaluation of palliative care effectiveness or of symptom control. This was dictated by previous experience and consensus. The aim was to provide uncomplicated information to the PCS, so as to encourage the participation of centers that may not be especially experienced in palliative care research.

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Disclosures and Acknowledgments 

This work was presented in poster form at the 5th European Association for Palliative Care Research Forum, Trondheim, Norway, May 2008. The study was supported, in part, by a grant from the FIS, Instituto Carlos III, Spanish Agency for Health Care Research. The funder was not involved in the conduct of the study or development of the submission. The authors declare no conflicts of interest.

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PII: S0885-3924(10)00500-2

doi:10.1016/j.jpainsymman.2010.02.026

Journal of Pain and Symptom Management
Volume 40, Issue 5 , Pages 652-660, November 2010

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