Abstract

Fifty percent of cancer patients suffer an from advanced stage of disease that unfortunately is not responsive to curative treatment; however, with palliative care, even these patients may live for years. Patients with advanced cancer may suffer from innumerable symptoms like pain, anorexia, nausea or vomiting, depression, dyspnea, malnutrition, dry mouth, anxiety, skin problems and sleeplessness.[1] The only available management for such patients is palliative care, which focuses primarily on pain relief.[2] World Health Organization (WHO) defines palliative care as “the total active care of the patient whose disease is not responsive to curative treatment”. Palliative care is concerned primarily with controlling symptoms, managing side effects and supporting overall quality of life when cure or control of the cancer is no longer believed to be possible.[3] More than 80% of patients with cancer develop pain before death. Control of pain, of all other symptoms, is of utmost importance. Traditionally, the success of cancer treatment has been measured by end points suchas patient survival or disease-free survival and assessing the tumor response, by change in tumor volume. Increasingly, researchers are faced with situations where patientsmay not gain benefits in terms of traditional end points. For these patients, quality of life assessment is important, especially when prolongation of survival is not expected. Quality of life is now recognized as an end point of secondary importance next only to survival.[4] Though well established in the West, the concept of palliative care is new to India, having developed only in the past few years. Since control of pain is most important than control of any other symptom, we have seen the association of pain intensity and quality of life. Pain is strongly associated with quality of life and has been suggested as an important indicator for quality of life of patients with cancer.[4] Several instruments have been developed to assess the quality of life in patients with cancer pain. Among them, the City of Hope Medical Center Quality of Life Survey is a validated, accurate and internationally accepted survey instrument.[5] The use of such a questionnaire allows evaluation of outcomes of palliative care and health-related quality of life and leads to better understanding of patient expectations. The aim of this study was to evaluate the outcome of palliative care in terms of improvement of quality of life of patients and correlate it with pain improvement.

The study was conducted in the Oncology Clinics of a tertiary care teaching hospital. It was an observational cohort prospective/follow-up study of patients with advanced cancer, undergoing palliative drug therapy. A total number of 100 advanced cancer patients were included in the study. Approval for the study was obtained from the hospital’s institutional research committee. After informed consent was obtained, patients with advanced cancer were recruited and followed up monthly for 2 months. Upon recruitment, demographic data, relevant medical history and previous drug therapy were all recorded. During the 2-month period, patients received medical treatment as judged necessary by responsible physicians and no effort was made to alter or modify the course of treatment. The effect of the palliative care was evaluated on mainly two parameters, namely, pain and quality of life. The instruments used to evaluate the patients included visual analog scale (VAS) for pain and the City of Hope Medical Center Quality of Life Survey for quality of life measurement. VAS is a scale presented as a horizontal row of equidistant numbers from 0 to 10, with the ratings given as “no pain” at 0 and “pain as bad as you can imagine” at 10.The quality of life instrument used in the study was the City of Hope Medical Center Quality of Life Survey. It is a multidimensional instrument developed to evaluate quality of life as a measure of pain management outcome in individual patients.[5] It consists of 28 VAS items with word extremes as anchors at each end. Item scores range from 0 to 100. This tool is modeled after the quality of life instruments tested by Padilla and Grant,[6] and includes items in the areas of psychological and physical well-being, general symptom control, specific symptom control, and social support. This instrument has undergone testing with cancer patients to explore reliability and sensitivity features to analgesic intervention.[5] Patients completed the instruments in the hospital setting. Although the questionnaire was designed as a self-reported scale, the high illiteracy rates in our population did not allow for effective use of self-reported questionnaire. Those patients having difficulty completed the questionnaire with assistance from the researcher. The researcher read out exactly what was written, did not change the items, and did not make any additional explanation and recorded their verbal responses. Data at the study entry, and 1 and 2-month follow-up were used for this analysis. Data were analyzed using the Statistical Package for Social Sciences (SPSS). Descriptive statistics were used for demographic characteristics and presented as percentage and mean±SD, where appropriate. Dependent t-test was used for analyzing the difference of pain and quality of life scores at baseline and subsequent follow-up. The Pearson correlation coefficient was used to analyze the association between the mean changes in pain levels and mean changes in quality of life scores. Significance for all analyses was taken at the 5% level. Changes of pain scores at baseline and follow-up were compared against the change of quality of life scores by analysis of variance.

A total of 100 patients were enrolled for the study. One-month follow-up of only 93 patients was available. Three patients expired and four were lost to follow-up. Only 51 patients were available for 2-month follow-up, as most of the patients were receiving only symptomatic palliative therapy and were mostly provided home care, hence lost for follow-up in the subsequent months. Table 1 shows the demographic profile of the patients. Out of 100 patients, 60 (60%) were men and 40 (40%) were women. The mean±SD age was 52.57±13.02 years (range 13–80), and the mean±SD Karnofsky index was 64.44±12.39 (range 40–90). The most common cancer presented in our study was lung cancer (34%), followed by gastrointestinal tract (25%), breast cancer (10%), head and neck cancer (9%), primary unknown tumor (8%), gynecological (7%) and other tumors (5%). At the time of diagnosis, 62 patients had distant metastasis, 80 had locally advanced disease and 7 had recurrent tumor. The common symptoms experienced by the patients included pain, weakness/fatigue, anorexia, insomnia, nausea/vomiting, dyspnea, constipation and cough. Pain was the most frequent symptom occurring in 95% of patients. At study entry, 62% of the patients reported severe pain as compared to only 3 and 1% at 1 and 2 months, respectively. The pain was controlled in all patients mainly with drugs according to World Health Organization (WHO) analgesic guidelines. Non-narcotic analgesics (WHO level 1) were used by 89.47% of the patients in pain. Weak opiates (WHO level 2) and strong opiates (WHO level 3) were administered in only 65.26 and 6.32% of the patients in pain, respectively. Apart from analgesics, otherdrugslike antiemetic, proton pump inhibitors, systemic antibiotics, antiasthmatics and vitamin supplements were among the most frequently used medications. Overall, the patients received 8.7±3.8 (mean±SD) drugs on an average during the observation period of 2 months. At the time of the study,55% of patients received palliative chemotherapy. Palliative surgery was done in 23% and radiotherapy was received by 23% of the patients. The mean pain intensity significantly decreased from baseline at both 1 and 2 month follow-up. In 93 patients, the mean±SD pain intensity at 1 month indicated a 63% reduction from baseline [7.13±2.2 vs. 2.62±2.1 (P<0 xss=removed>P<0 xss=removed>P<0 xss=removed>P<0 xss=removed>P<0 xss=removed>P<0 href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3089919/table/T0002/" target="table" class="fig-table-link figpopup" rid-figpopup="T0002" rid-ob="ob-T0002" co-legend-rid="" xss=removed>Table 2]. There was a high correlation between the average change in pain severity and quality of life total scores (r= −0.53, P<0 href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3089919/table/T0003/" target="table" class="fig-table-link figpopup" rid-figpopup="T0003" rid-ob="ob-T0003" co-legend-rid="" xss=removed>Table 3, Figure 1].