Patient Satisfaction with Quality of Life as a Predictor of Survival in Pancreatic Cancer

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1 International Journal of Gastrointestinal Cancer, vol. 37, no. 1, , 2006 Copyright 2006 by Humana Press Inc. All rights of any nature whatsoever reserved /06/37:35 43/$30.00 Research Article Patient Satisfaction with Quality of Life as a Predictor of Survival in Pancreatic Cancer Christopher G. Lis, * Digant Gupta, and James F. Grutsch Cancer Treatment Centers of America (CTCA) at Midwestern Regional Medical Center, Zion, IL Abstract Background: The goal of this study was to evaluate the association between patient satisfaction with quality of life (QoL) and survival in pancreatic cancer patients undergoing care in a community hospital comprehensive cancer center. Patients and Methods: A consecutive case series of 55 cases of histologically confirmed pancreatic cancer treated at Cancer Treatment Centers of America at Midwestern Regional Medical Center was studied between 04/01 and 11/04. The Quality of Life Index (QLI) was utilized to assess patient satisfaction with QoL. QLI measures global QoL as well as the QoL in four major subscales: health and physical, social and economic, psychological and spiritual, and family. All scores range from 0 to 30 with higher scores indicating a better QoL. The Kaplan Meier method was used to calculate survival. Log-rank test was used to study the equality of survival distributions. Multivariate Cox regression analyses were then performed to evaluate the joint prognostic significance of those QoL and clinical factors that were shown to be prognostic in univariate analyses. Results: Of the 55 patients, 28 were newly diagnosed and 27 had prior treatment history. The median age was 55 yr (range yr). A majority (34) had stage IV disease at diagnosis. Health and physical subscale, family subscale, and global QoL were significantly associated with survival upon univariate analysis. Health and physical subscale was marginally significant upon multivariate analysis after controlling for the effects of stage at diagnosis. Conclusions: We found that baseline patient satisfaction with QoL, as measured by the QLI, provides useful prognostic information in patients with pancreatic cancer. While these findings require further investigation in large patient cohorts, they may have important implications for patient stratification in clinical trials, as well as aid in clinical decision-making. Key Words: Quality of life; patient satisfaction; pancreatic cancer; prognosis. Introduction Pancreatic cancer is a common malignancy with approx 30,000 cases diagnosed every year in the *Author to whom all correspondence and reprint requests should be addressed: Christopher G. Lis, MPH, Vice President of Research, Cancer Treatment Centers of America, 2610 Sheridan Road, Zion, IL Tel: , Fax: , christopher.lis@ctca-hope.com. United States (1). It is the fourth leading cause of cancer deaths in the United States after lung, breast/ prostate, and colorectal cancer (2,3). Pancreatic cancer is known for its debilitating symptoms, and despite considerable progress in the areas of epidemiology, molecular genetics, diagnostics, operative techniques, and patient management, the overall 5-yr survival rate for pancreatic cancer is 4.4%, whereas for distant stage pancreatic cancer is merely 35

2 36 Lis, Gupta, and Grutsch 1.6% (2,4). Over 90% of the patients die within 1 yr of diagnosis and, for the majority of patients, treatment is aimed at palliation of symptoms only. Fatigue; loss of appetite; pain; and reduced physical, cognitive, and emotional function are issues of major concern in palliative care of these patients (5). Consequently, consideration of quality of life (QoL) becomes a subject of paramount importance in patients with pancreatic cancer. QoL is a multidimensional construct. There is a growing consensus in the medical and clinical research community that the efficacy of therapeutic interventions should be evaluated with survival endpoints as well as QoL endpoints. This view has led to the inclusion of QoL as a primary endpoint in cancer clinical trials in conjunction with the traditional endpoints, such as tumor response and survival. QoL is increasingly being evaluated with the aid of psychometrically robust questionnaires that classify patients QoL into a number of functional and symptom domains. The use of QoL assessment as a predictor of survival is of interest to many clinicians. There are extensive data in the literature showing that QoL tools measuring the activities of daily life can predict survival in several different types of cancers independent of the extent of the disease and other clinical prognostic factors (6 26).These studies have used different combinations of clinical and QoLfactors in multivariate models evaluating the prognostic significance of each on clinical outcomes. These studies have used a variety of QoL tools to measure the activities of daily living, the most commonly used instrument being the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). However, there is little to no information on the prognostic significance of tools measuring patient satisfaction with QoL in cancer. The Ferrans and Powers Quality of Life Index (QLI) is one such tool that measures patient satisfaction with QoLin a subjective and selfreported manner. QLI defines QoLas a person s sense of well-being that stems from satisfaction or dissatisfaction with the areas of life that are important to him/her (27 30). This definition takes into consideration the fact that different people have different values, which causes aspects of life to vary in their impact on QoL. Earlier we had shown that QLI provides useful prognostic information in patients with colorectal cancer treated at our hospital (31). The present study, which is a sequel to our prior research, aims to determine whether patient satisfaction with their QoL, as measured by the QLI, would predict length of survival in patients with pancreatic cancer undergoing care in our nonclinical trial setting. Materials and Methods Study Sample We examined a consecutive case series of 55 histologically confirmed pancreatic cancer patients treated at Cancer Treatment Centers of America at Midwestern Regional Medical Center (MRMC) between April 2001and November None of these patients had received any treatment at MRMC when contacted to participate in this investigation. The inclusion criteria for participation in this study were a histological diagnosis of pancreatic cancer and the ability to read English. Patients with all stages of pancreatic cancer were eligible for the study. Patients were excluded if they were unable to provide informed consent or were unable to understand or cooperate with study conditions. Atrained clinical coordinator described the study and determined eligibility after patients signed in at the clinic. As part of the consent process, patients were assured that refusal to participate in the study would not affect their future care in anyway. Eligible patients were presented with the questionnaires at their initial visit and returned their completed questionnaires to the clinical coordinator within 24 h. Patients filled in the questionnaires at admission to the hospital before they had the opportunity to undergo therapy. Other patient information recorded for this study was age at presentation (current age), stage of disease at diagnosis, and prior treatment history. The only follow-up information required was the date of death or the date of last contact/last known to be alive. This study was approved by the Institutional Review Board at Midwestern Regional Medical Center. QoL Assessment QoL was assessed using QLI. The QLI measures global QoL and the QoL in four major subscales: health and physical, social and economic, psychological and spiritual, and family. Each subscale includes questions on satisfaction and personal

3 Quality of Life Index and Pancreatic Cancer 37 importance of the subscale. Each question on satisfaction with a particular aspect of life is later followed by a question on the importance of that aspect of life. For example, the question how satisfied are you with your health under the satisfaction section of the questionnaire is accompanied by the question how important to you is your health under the importance section of the questionnaire. Ratings are made on a 1 6 scale ranging from very dissatisfied/unimportant to very satisfied/important. Scores are determined by weighting satisfaction responses with importance responses. This weighting adjusts for the influence of individual values and thus produces a more accurate reflection of QoL. All scores range from 0 to 30 with higher scores indicating a better QoL. This questionnaire is valid, reliable, and sensitive and has been used in many studies involving cancer patients. Prespecified Baseline Clinical Factors Baseline clinical factors that were assessed for prognostic significance were current age, stage of disease at diagnosis, and prior treatment history. The prior treatment history variable categorized the patients into those who have received definitive cancer treatment elsewhere before coming to our institution and those who were newly diagnosed at our institution. Data Analysis and Statistical Methods All data were analyzed using SPSS Version 11.5 (SPSS Inc., Chicago, IL). Study patients were dichotomized into two groups based on the median scores for all QoL subscales to yield good (above median) and poor (below median) scores. Patient survival was defined as the time interval between the date of first patient visit to the hospital and the date of death from any cause or the date of last contact/last known to be alive. Survival data were obtained from MRMC tumor registry. The prespecified baseline clinical factors and QoL parameters were evaluated for prognostic significance using the Kaplan Meier or product-limit method. Stage at diagnosis variable was categorized into two groups of stages I, II, and III (early stage) and stage IV (late stage). Stages I, II, and III were grouped together because of small number of cases in each one of them. The log rank test statistic was used to evaluate the equality of survival distributions across the two strata of all QLI subscales. A difference was considered to be statistically significant if the p value was less than or equal to Clinical and QoLfactors were also evaluated using univariate Cox regression analyses to determine which parameters showed individual prognostic value for survival. Multivariate Cox regression analyses were then performed to evaluate the joint prognostic significance of those QoL and clinical factors that were shown to be prognostic in univariate analyses. Each QLI factor was treated as a continuous variable for the purpose of Cox regression analyses. Results Patient Characteristics Of the 55 patients, 28 were newly diagnosed while 27 had prior treatment history. The median age at presentation was 55 yr (range yr). Table 1 describes the baseline characteristics of our patient cohort in greater detail. Table 2 describes the means, medians, and standard deviations of QLI subscale scores. Among the QLI subscales, the health and physical subscale had the lowest mean score of 13.9, while the highest mean score of 24.1 was recorded for the family subscale. Univariate Analysis: Prognostic Factors for Overall Survival Table 3 lists the results of univariate survival analyses for each QLI subscale using the Kaplan Meier method. The median survival in months, along with their corresponding 95% confidence intervals (CIs), is provided for both categories (good and poor) of all QLI subscales. The only parameters to show a statistically significant association with survival were the health and physical subscale and the family subscale. Figure 1 shows the survival curves for the median dichotomized categories of all QLI subscales. Table 4 displays the results of univariate analysis for stage at diagnosis and prior treatment history. The stage at diagnosis was found to be statistically significantly associated with survival while prior treatment history was not. Table 5 lists the results of univariate Cox regression analyses for each QLI subscale, global QoL, and current age. Upon univariate Cox regression analysis with survival as the end point, every 1 unit increase in health and physical subscale was associated with a relative risk of 0.92 (95% CI: , p value = 0.008). Similarly, every one unit increase

4 38 Lis, Gupta, and Grutsch Table 1 Baseline Characteristics of 55 Pancreatic Cancer Patients Characteristic Categories Number Percent Current age Mean 56.2 Median 55 Range Gender Male Female Tumor stage at diagnosis Stage Stage Stage Stage Missing Vital status Expired Alive Treatment history Newly diagnosed Prior treatment history Table 2 Baseline QLI Scores of 55 Pancreatic Cancer Patients QLI Subscale Mean Median Standard deviation Range Health and physical Social and economic Psychological/spiritual Family Global QLI Table 3 Univariate Kaplan Meier Survival Analysis for QLI Parameters Median Log-rank Survival in months Survival in months QLI Scale score score (below median) (above median) p value Health and physical ( ) 12.1 ( ) Social and economic ( ) 8.9 ( ) 0.86 Psychological and spiritual ( ) 9.7 ( ) 0.77 Family ( ) 11.5 ( ) 0.04 Global QLI ( ) 12.1 ( ) 0.08 Values in parentheses indicate 95% confidence intervals. in global QoL was associated with a relative risk of 0.90 (95% CI: , p value = 0.03). Family subscale was also found to be significant. Current age was not found to be predictive of survival and was not considered further. Multivariate Analysis: Prognostic Factors for Overall Survival The four variables (health and physical subscale, family subscale, global QoL, and stage at diagnosis) found to be significant upon univariate analysis

5 Quality of Life Index and Pancreatic Cancer 39 Fig. 1. Overall survival stratified by the median-dichotomized categories of all QLI subscales. Each drop in a probability curve indicates one or more events in that group. Vertical lines indicate censored patients, i.e., those who reached the end of their follow-up without experiencing death.

6 40 Lis, Gupta, and Grutsch Table 4 Univariate Survival Analysis for Clinical Factors Log-rank Median survival in months Clinical variable score (95% CI) p value Stage at diagnosis Early stage (I, II and III) (6.0, 16.9) 0.04 Late stage (IV) 7.5 (3.7, 11.4) Prior treatment history Newly diagnosed (6.3, 13.2) 0.8 Previously treated 7.7 (3.2, 12.3) CI, confidence interval. Table 5 Univariate Cox Regression Analysis Variable Unit of increase RR a 95% CI b p value Health and physical to Social and economic to Psychological and spiritual to Family to Global QLI to Current age to a Relative risk (Cox proportional hazard). b Confidence interval. Table 6 Multivariate Cox Regression Analysis for Overall Survival Variable Unit of increase RR a 95% CI b p value A. Health and physical subscale to Stage at diagnosis Early stage as reference to B. Family subscale to Stage at Diagnosis Early stage as reference to C. Global QLI to Stage at Diagnosis Early stage as reference to a Relative risk (Cox proportional hazard). b Confidence interval. were included in multivariate Cox regression modeling. The QLI subscales were used as continuous variables while stage at diagnosis was used as a categorical variable. Table 6A displays the results of multivariate analysis including health and physical subscale and stage at diagnosis. Similarly, Tables 6B and 6C display the results for family and global QoL after controlling for stage at diagnosis. No QLI subscale was found to be statistically significant after controlling for stage at diagnosis although the health and physical subscale was found to be marginally significant (p = 0.053). Discussion The identification of prognostic factors in advanced pancreatic cancer is of considerable importance for the clinical management of the disease. Symptom control and disease control are of supreme importance in patients with pancreatic cancer. Con-

7 Quality of Life Index and Pancreatic Cancer 41 sequently, QoL should be a prime concern in deciding on the best course of action in these patients whose survival is limited. While QoLhas been shown to have an association with survival in several types of cancer, there are no studies in the literature documenting the prognostic significance of patient satisfaction with QoL in pancreatic cancer. The current study was undertaken to investigate if patient satisfaction with QoL, as measured by the QLI, could predict survival in pancreatic cancer. We chose QLI as a valid and a reliable tool to assess patient satisfaction with QoL. Using QLI to measure patient satisfaction with QoL has several advantages over the QoL tools that measure activities of daily living. QLI is a statement from the patients on how they characterize the effects, good or bad, of their medical condition on their perceived well-being. The QLI asks the patients how satisfied they are with their life in the face of a life-threatening disease. This view of QoL assumes that only the patient can provide an objective evaluation of the impact of the treatment of a life-threatening disease on their well-being. Consequently, from the point of view of the patient, the data on the impact of disease and its treatment, is different from the data on patients physical function, and can provide valuable information in the oncology clinic. We found that the baseline health and physical subscale, family subscale, and global QoLwere predictive of survival in pancreatic cancer. The association between QoL and survival has been noted in several studies of patients with advanced cancer. One study in advanced colorectal cancer using the QLQ-C30 instrument found that baseline QoL was a strong independent predictor of survival and suggested that QoL measurements should be routinely recorded in clinical trials to stratify cohorts and aid in clinical trial comparison (22). Another study in 50 patients with colorectal liver metastasis using the Rotterdam Symptom Checklist and the Hospital Anxiety and Depression Scale found that diarrhea, restlessness, and ability to work and sleep were the best predictors of survival (13). Similarly, a study conducted in patients undergoing surgery for rectal cancer using the QLQ-C30 and Short Form 36 instruments found that preoperative QoL (physical function, nausea/vomiting, and sexual enjoyment) was a good predictor of survival at 1 yr (32). In a study conducted by Dancey, et al. in a general population of cancer patients receiving chemotherapy, global QoL, as measured by the QLQ-C30, was found to be significantly associated with survival (11). In another study conducted by Coates, et al. in patients with advanced malignancy, global QoL, and social functioning subscale, as measured by QLQ-C30, were found to be independently prognostic of survival after controlling for age, performance status, and metastatic site (8). A study in advanced breast cancer using linear analog self-assessment instrument found that baseline physical well-being, mood, nausea and vomiting, appetite, and global QoL were significant predictors of subsequent survival (7). Similarly, a study in advanced breast cancer using QLQ-C30 instrument found more severe pain at baseline to be predictive of overall survival (21). Our previous study conducted in 177 colorectal cancer patients found that baseline patient satisfaction with QoL, as measured by the QLI, provides useful prognostic information in patients with colorectal cancer independent of tumor stage at diagnosis and prior treatment history (31). While the findings of our study are similar to those reported by other researchers, direct comparisons between the studies is not possible due to differences in the QoL instruments used and the clinical and demographic factors controlled for in the analyses. It can be argued that patients self-reported QoL, as measured by the QLI, presumably captures those aspects of disease severity that may not be apparent in the observer-rated performance status or tumor burden. QLI seems to capture the impact of cancer and its treatment on multiple dimensions of patients lives. The results of this study have important implications for both clinical and research practice. Health care professionals interested in survival should carefully evaluate the results of baseline QoL and take them into consideration while planning treatment. The usefulness of the association described in this study can ultimately be demonstrated if interventions aimed at enhancing QoL are shown to enhance survival. Although this study raises interesting questions, several limitations require careful acknowledgment. The patient cohort was limited to only those patients who were English-speakers. This study sample, therefore, is not broadly representative of cancer patients in the general population. A majority of our patients had advanced-stage disease at presentation to our hospital. As a result, generalizability of the study findings to cancer patients with early-stage

8 42 Lis, Gupta, and Grutsch disease might be questionable. However, we have no reasons to believe that patients with early-stage disease will display different findings. In any case, this research question needs to be tested in other cancer patient populations at different stages of disease. Information on tumor stage at diagnosis was not available for eight patients. As a result, the univariate and multivariate Cox models evaluating tumor stage were restricted to 47 patients only. This study does not establish a causal relationship between QoL and survival, because QoL may merely act as a marker for an otherwise undetected prognostic variable (8). We did not control for the multiple comparisons made in this study, but this is acceptable for hypothesis-generating studies (24). Finally, we did not evaluate the prognostic significance of changes in QoL scores during treatment. However, the study has several strengths, including no missing data on any QLI subscale for the entire study sample; high compliance with the completion of the questionnaire; a consistent population of patients most of whom had advanced pancreatic cancer at presentation to our hospital; the use of a valid and reliable QoL instrument; the availability of clinical parameters in nearly all patients; and availability of mature and reliable survival data. In summary, our study has demonstrated the prognostic significance of patient satisfaction with QoL in pancreatic cancer. To the best of our knowledge, this is the first study in the literature to evaluate QLI for its prognostic importance in pancreatic cancer. Acknowledgments Drs. Gupta and Grutsch had full access to all the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis. This study was funded by Cancer Treatment Centers of America (CTCA). Design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript were conducted by the authors of this study, who take responsibility for its content. We thank Thom Wodek for his assistance with collection and assembly of data and administrative support for this project. We also thank Norine Oplt, chief of our Cancer Registry, for providing us with reliable and updated survival data. Reference List 1. Jemal A, Murray T, Ward E, et al. Cancer statistics, CA Cancer J Clin 2005;55(1): Rocha Lima CM, Centeno B. Update on pancreatic cancer. Curr Opin Oncol 2002;14(4): Shaib YH, Davila JA, El Serag HB. The epidemiology of pancreatic cancer in the United States: changes below the surface. Aliment Pharmacol Ther 2006;24(1): Bohmig M, Rosewicz S. [Pancreatic carcinoma]. Z Gastroenterol 2004;42(3): Labori KJ, Hjermstad MJ, Wester T, et al. Symptom profiles and palliative care in advanced pancreatic cancer-a prospective study. Support Care Cancer2006;14(11) Blazeby JM, Brookes ST, Alderson D. Prognostic value of quality of life scores in patients with oesophageal cancer. Br J Surg 2000;87(3): Coates A, Gebski V, Signorini D, et al. Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer. Australian New Zealand Breast Cancer Trials Group. J Clin Oncol 1992;10(12): Coates A, Porzsolt F, Osoba D. Quality of life in oncology practice: prognostic value of EORTC QLQ-C30 scores in patients with advanced malignancy. Eur J Cancer 1997; 33(7): Coates AS, Hurny C, Peterson HF, et al. Quality-of-life scores predict outcome in metastatic but not early breast cancer. International Breast Cancer Study Group. J Clin Oncol 2000;18(22): Collette L, van Andel G, Bottomley A, et al. Is baseline quality of life useful for predicting survival with hormonerefractory prostate cancer? Apooled analysis of three studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group. J Clin Oncol 2004; 22(19): Dancey J, Zee B, Osoba D, et al. Quality of life scores: an independent prognostic variable in a general population of cancer patients receiving chemotherapy. The National Cancer Institute of Canada Clinical Trials Group. Qual Life Res 1997;6(2): Dharma Wardene M, Au HJ, Hanson J, et al. Baseline FACT-G score is a predictor of survival for advanced lung cancer. Qual Life Res 2004;13(7): Earlam S, Glover C, Fordy C, et al. Relation between tumor size, quality of life, and survival in patients with colorectal liver metastases. J Clin Oncol 1996;14(1): Efficace F, Biganzoli L, Piccart M, et al. Baseline healthrelated quality-of-life data as prognostic factors in a phase III multicentre study of women with metastatic breast cancer. Eur J Cancer 2004;40(7): Fang FM, Liu YT, Tang Y, et al. Quality of life as a survival predictor for patients with advanced head and neck carcinoma treated with radiotherapy. Cancer 2004;100(2): Fang FM, Tsai WL, Chiu HC, et al. Quality of life as a survival predictor for esophageal squamous cell carcinoma

9 Quality of Life Index and Pancreatic Cancer 43 treated with radiotherapy. Int J Radiat Oncol Biol Phys 2004;58(5): Fang FM, Liu YT, Tang Y, et al. Quality of life as a survival predictor for patients with advanced head and neck carcinoma treated with radiotherapy. Cancer 2004;100(2): Fang FM, Tsai WL, Chiu HC, et al. Quality of life as a survival predictor for esophageal squamous cell carcinoma treated with radiotherapy. Int J Radiat Oncol Biol Phys 2004;58(5): Kramer JA, Curran D, Piccart M, et al. Identification and interpretation of clinical and quality of life prognostic factors for survival and response to treatment in first-line chemotherapy in advanced breast cancer. Eur J Cancer 2000;36(12): Langendijk H, Aaronson NK, de Jong JM, et al. The prognostic impact of quality of life assessed with the EORTC QLQ-C30 in inoperable non-small cell lung carcinoma treated with radiotherapy. Radiother Oncol 2000;55(1): Luoma ML, Hakamies Blomqvist L, Sjostrom J, et al. Prognostic value of quality of life scores for time to progression (TTP) and overall survival time (OS) in advanced breast cancer. Eur J Cancer 2003;39(10): Maisey NR, Norman A, Watson M, et al. Baseline quality of life predicts survival in patients with advanced colorectal cancer. Eur J Cancer 2002;38(10): Montazeri A, Milroy R, Hole D, et al. Quality of life in lung cancer patients: as an important prognostic factor. Lung Cancer 2001;31(2 3): Roychowdhury DF, Hayden A, Liepa AM. Health-related quality-of-life parameters as independent prognostic factors in advanced or metastatic bladder cancer. J Clin Oncol 2003;21(4): Tamburini M, Brunelli C, Rosso S, Ventafridda V. Prognostic value of quality of life scores in terminal cancer patients. J Pain Symptom Manage 1996;11(1): Herndon JE, Fleishman S, Kornblith AB, et al. Is quality of life predictive of the survival of patients with advanced nonsmall cell lung carcinoma? Cancer 1999;85(2): Ferrans CE, Powers MJ. Quality of life index: development and psychometric properties. ANS Adv Nurs Sci 1985; 8(1): Ferrans CE. Development of a quality of life index for patients with cancer. Oncol Nurs Forum 1990;17(3 Suppl): Ferrans CE, Powers MJ. Psychometric assessment of the Quality of Life Index. Res Nurs Health 1992;15(1): Ferrans CE. Development of a conceptual model of quality of life. Sch Inq Nurs Pract 1996;10(3): Lis CG, Gupta D, Granick J, Grutsch JF. Can patient satisfaction with quality of life predict survival in advanced colorectal cancer? Support Care Cancer 2006; 14(2): Camilleri Brennan J, Steele RJ. Prospective analysis of quality of life and survival following mesorectal excision for rectal cancer. Br J Surg 2001;88(12):

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