ASSOCIATION FOR ACADEMIC SURGERY Quality of Life Assessment in Postoperative Patients with Upper GI Malignancies

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1 Journal of Surgical Research 163, (2010) doi: /j.jss ASSOCIATION FOR ACADEMIC SURGERY Quality of Life Assessment in Postoperative Patients with Upper GI Malignancies Jane R. Schubart, Ph.D.,*,1 James Wise, D.M., Isabelle Deshaies, M.D., Eric T. Kimchi, M.D., Kevin F. Staveley-O Carroll, M.D., Ph.D., and Niraj J. Gusani, M.D.k *Departments of Surgery, Public Health Sciences, and Medicine, The Pennsylvania State University, College of Medicine, Hershey, PA; Chaplain Services, Penn State Milton S. Hershey Medical Center, Hershey, PA; Division of Surgical Oncology, Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA; Division of Surgical Oncology, Department of Surgery, Department of Microbiology and Immunology, The Pennsylvania State University, College of Medicine, Hershey, PA; and kdivision of Surgical Oncology, Department of Surgery, and Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, PA Submitted for publication January 6, 2010 Background. By current estimates there are more than 10.8 million cancer survivors in the United States. Increasingly, oncologists are realizing that despite the success of cancer therapies, cancer survivors are facing previously unrecognized psychosocial issues related to cancer survivorship. In GI cancers, the medical and surgical oncologists charged with the care of the patient are not -equipped to deal with these issues. At our institution s GI Cancer Survivorship Clinic, we utilize a multi-disciplinary model, led by surgical oncologists, that includes psychologic and pastoral support as a priority. The goal of this study was to assess our patients quality of life (QOL) in order to better understand their survivorship needs and to optimize survivor care. Materials and Methods. Patients with upper GI malignancies undergoing post-treatment evaluation completed the Functional Assessment of Chronic Illness Therapy-Spirituality Scale (FACIT-Sp) questionnaire that includes five domains of QOL: physical ; social/family ; emotional ; functional ; and spiritual. Results. The results of our evaluation of health related QOL in a sample of 99 patients revealed higher self-reported QOL than those seen in a normative sample of cancer patients. Social/family was strongly associated with total QOL scores, and married patients reported higher social/family, as as higher overall QOL. 1 To whom correspondence and reprint requests should be addressed at Penn State Hershey Cancer Institute, 500 University Drive, mail code: CH69, Hershey, PA jschubart@hmc. psu.edu. Conclusions. Cross-sectional evaluation of health related QOL in our patients revealed higher selfreported QOL than those seen in a normative sample of general cancer patients. Despite aggressive surgical and medical treatment for malignancies with a generally poor prognosis, the results of our pilot study suggest that cancer survivors treated and followed in a multidisciplinary setting can experience acceptable health-related QOL. Ó 2010 Elsevier Inc. All rights reserved. Key Words: quality of life; hepatic cancer; pancreatic cancer; esophageal cancer; gastric cancer; surgical procedures, operative. INTRODUCTION Survivors of cancer are becoming an increasingly large segment of the U.S. population. Currently, there are more than 10.8 million cancer survivors in the United States, representing 3.7% of the population [1]. Overall, 64% of adults diagnosed with cancer will be alive 5 y after diagnosis [2]. As outcomes for cancer treatment improve, this burgeoning group of cancer survivors presents oncology professionals with a new set of medical issues and challenges. Patients with cancer of the GI tract (esophagus, stomach, liver, biliary tract, and pancreas) have among the worst prognosis of all cancer patients. Most patients with these tumors have less than a 20% chance of long-term survival. Despite these difficult odds, with recent improvements in chemotherapeutic treatment regimens, perioperative care, and surgical techniques, more and more of these patients are becoming longterm survivors. Between 1975 and 2003, 5-y survival /$36.00 Ó 2010 Elsevier Inc. All rights reserved. 40

2 SCHUBART ET AL.: QUALITY OF LIFE ASSESSMENT IN POST-OPERATIVE PATIENTS 41 rates have increased dramatically for colorectal cancer (50% to 66%), esophageal cancer (6% to 18%), stomach cancer (15% to 22%), pancreatic cancer (3% to 5%), and liver and bile duct cancer (4% to 10%) [1]. Recent advances in operative techniques and perioperative care have resulted in decreased mortality and morbidity in patients with gastrointestinal malignancies undergoing surgical treatment. For example, postoperative mortality after major hepatic surgery has decreased to less than 5% and the indications for liver resection have expanded [3]. Surgeries that used to be considered experimental or extreme are now standard care, and with prolonged survival possible, quality of life has become an important endpoint. Treatments for gastrointestinal cancers often include complex, toxic chemotherapy regimens, radiation, and major abdominal surgery with a long recovery process. Complex gastrointestinal tract surgery can result in dietary restrictions, altered bowel function, nausea and vomiting, diarrhea, or abdominal pain. Often these symptoms are self-limited, but they may persist to varying degrees. Lack of appetite, altered taste, difficulty swallowing, and weight loss may be seen in the postoperative period or in the face of recurrence in surgery for esophageal or gastric cancer. Patients undergoing pancreatic surgery face the long-term risks of diabetes and impaired fat absorption resulting in diarrhea. Impaired wound healing is a higher risk for many of our patients due to lengthy surgeries involving multiple organs. As a result of poor nutrition and wound complications, these cancer patients are at higher risk for postoperative herniation after their surgeries. Health-related quality of life (QOL) is a multidimensional concept encompassing domains that include physical, functional, social, and emotional - [4]. Common sequelae that disrupt the psychosocial aspects of life for adult cancer survivors after primary treatment include fatigue, cognitive changes, body image, sexual health, fear of recurrence, family/caregiver distress, socioeconomic issues, and distress/anxiety/depression. Recent reports [5, 6] describe the unique and sometimes poorly understood challenges faced by cancer survivors as they transition from active treatment to post-treat ment and adjust to a new normal [7]. Our successes in the treatment of aggressive GI tract cancers have led to new problems for our patients after their recovery from treatment. Faced with significant changes in their anatomy and physiology from surgery, persistent side effects, and late effects from their chemotherapy, and often social and emotional challenges from their treatment and recovery process, the survivors of gastrointestinal tract cancers often do not enjoy an optimal quality of life in the post-treatment period. Recognizing that GI cancer survivors may be facing a unique range of post-treatment issues, we initiated a GI Cancer Survivorship Clinic utilizing a multidisciplinary approach that includes psychologic and pastoral support as a means to address previously unrecognized psychosocial needs [8]. We began collecting QOL data in order to better understand our patients needs. MATERIALS AND METHODS Participants This prospective study was designed to assess the quality of life (QOL) of patients followed in our institution s weekly GI Cancer Survivorship Clinic. Over the period October 2008 to August 2009, health-related QOL data was collected from a sample of 99 followup patients in our GI Cancer Survivorship Clinic. All patients had completed their surgical and adjuvant therapies. Patients were approached during their routine follow-up visit by one of the investigators (JRS) in the clinic exam room and asked to complete a single QOL survey questionnaire, the FACIT-Sp. Participation was voluntary and verbal consent was obtained from all eligible participants. Demographics and information about the patient s disease and treatment were extracted from the electronic medical record. Measures Patients completed the Functional Assessment of Chronic Illness Therapy Spirituality Scale (FACIT-Sp) questionnaire. This instrument was developed for use in patients with progressive, life-limiting illness. The FACIT-Sp combines the FACT-G core instrument, originally developed for patients with cancer, with a spiritual subscale. The FACIT-Sp includes 39 items, which are scored on a 5-point Likert scale (0 ¼ not at all to 4 ¼ very much) and assesses five domains: physical (seven items), social/family (seven items), emotional (six items), functional (seven items), and spiritual (12 items). Higher scores indicate a more favorable perception of health related QOL [9]. The reliability and validity of the core instrument have been demonstrated to be high in patients with cancer and other serious illness [10 12]. Statistical Analysis The data were first examined using scatter plots and histograms, and descriptive statistics were calculated for all variables. We examined the correlations between FACIT-Sp total and subscale scores, and the correlations to time since last surgery, age, and marital status. We computed Sidak P values, which is a rigorous approach to adjust for multiple comparisons. Lastly, multivariate analysis was conducted to determine whether other variables explained the associations and to adjust for confounding or mediating variables. Human Subjects Consideration This study was approved by the Penn State University Institutional Review Board (IRB protocol no ). RESULTS Between October 2008 and August 2009, the FACIT- Sp instrument was administered to 99 patients. Participant characteristics are summarized in Table 1. Mean QOL scores were calculated across all patients for each

3 42 JOURNAL OF SURGICAL RESEARCH: VOL. 163, NO. 1, SEPTEMBER 2010 Variable TABLE 1 Participant Characteristics N Gender 99 Male: 51% Race 99 Caucasian: 73%Other: 27% Age (median) 99 Males: 67 (range 43 88)Females: 61 (range 22 86) Marital status 99 Married: 73% Time since surgery (mean) mo (range 0 86) subscale domain and for the FACT-G and FACIT-Sp instruments as a whole (Table 2). The quality of life scores in our sample tend to be negatively skewed as illustrated by the FACIT-Sp distribution (Fig. 1). There were no significant differences between females and males. Age did not associate with QOL scores; however, married patients had consistently higher QOL scores compared with other categories (P < 0.001). A greater time since surgery was associated with better emotional (adjusted P value ¼ 0.038), better functional (adjusted P value ¼ 0.003), and higher FACT-G and FACIT-Sp total scores (adjusted P value ¼ 0.006). We examined the correlation of social/family to the other sub-scales, hypothesizing that higher social support would be related to higher emotional, functional and spiritual. As the results in Table 3 show, after adjusting for multiple comparisons, we can say conservatively that social/family is associated with spiritual and also associated with total QOL scores. The association with emotional and functional is less apparent. Time since Surgery The number of months since surgery correlated moderately with the subscales of emotional (r ¼ 0.325, P ¼ ) and spirituality (r ¼ 0.307, P ¼ ). Large correlations were found for months since surgery and functional (r ¼ , P < ) and the FACT-G Total score (r ¼ , P ¼ ), and FACIT-Sp total score (r ¼ , P ¼ ). Scatter plots (Fig. 2) suggest heterogeneity of the variance, with scores varying across the spectrum for the earlier months and clustering towards higher scores as time since surgery increases. Differences by Type of Surgery All patients had undergone major abdominal surgeries for advanced cancer. We compared QOL scores (subscales and total scores) by category of surgery as shown in Table 4. We did not have sufficient sample size in this pilot study to detect associations between quality of life and prognosis. Comparative Data Normative data in a cross-section of adult U.S. cancer patients for the FACT-G has been published by the authors of the FACIT measurement system [13] and is shown in Table 5. The normative FACT-G sample data combined data sets from two previous validation studies, funded by the National Institutes of Health, of the FACT measurement system. Data were collected from adult patients located in six cities (Atlanta, Chicago, Philadelphia, Baltimore, Toledo, and San Juan, Puerto Rico), in both public care and private care settings. Cancer diagnoses in the first study included breast cancer, lung cancer, colorectal cancer, head/neck cancer. All cancer diagnoses were included in the second study. All participants had a life expectancy of at least 3 mo. Compared with these data, our patients reported a trend toward a higher QOL across all subscales of the FACT-G. Furthermore, these differences approach clinical importance based on published criteria that describe minimally important difference (MID) estimates as follows: FACT-General (FACT-G) subscales ¼ 2 3; FACT-G ¼ 6 7 [14]. Key Themes from Individual Questions We examined responses to the individual FACIT-Sp questions to look for common themes. On the physical TABLE 2 Summary of FACIT-Sp Quality of Life Scores Variable Possible score range n* Mean Std. Dev. Range Physical Social/family Emotional Functional Spiritual FACT-G total score FACIT-Sp total score * Varies by subscale because only subscales with complete data were analyzed.

4 SCHUBART ET AL.: QUALITY OF LIFE ASSESSMENT IN POST-OPERATIVE PATIENTS 43 FIG. 1. Females (upper histogram) show better overall QOL than males (lower). (Color version of figure is available online.) subscale, lack of energy was the most common complaint. Overall, the scores for social/family support were good, with patients reporting the highest support from family and moderate-high support from friends. Patients scored high in emotional although most admitted that they feel sad, feel nervous, worry about dying, and worry that my condition will get worse. Most patients were satisfied with the way they are coping with their illness and did not feel that they were losing hope. In functional, patients reported that work (including work at home) was only somewhat fulfilling. About half were not sleeping (reported somewhat ) although overall most were satisfied with the quality of their life. DISCUSSION Rigorous quality of life evaluation in GI cancer patients is critically important as more patients become survivors. As a research field, post-surgical quality of TABLE 3 Correlation of the Social/Family Well Being Subscale Variable Raw P value Adjusted P value Physical subscale Emotional subscale Functional subscale Spiritual subscale FACT-G total score FACIT-Sp total score life evaluation is still evolving. Our data reflect a point in time estimate of health-related quality of life for a broad set of patients following surgery and medical therapy for GI-tract and abdominal cancers. We chose a FACIT instrument to measure the health related QOL of our patients because we were especially interested in the various components of QOL, including domains of social and family support and spirituality that are particularly relevant to advanced cancer. Prior studies have reported that some cancer survivors who report a greater number of physical problems (such as pain or limitations in physical activities) report a relatively good general quality of life, especially with regard to mental health and social and psychological compared with their matched controls.[3] The changes that we observed in patient self-reported QOL over time are consistent with prior published studies. For example, Dasgupta et al. [15], in a longitudinal study of 103 patients undergoing liver resection for hepatobiliary malignancy, reported that most functional scales of the cancer-specific European Organization for Research and Treatment for Cancer core questionnaire (EORTC QLQ-C30), as as the global QOL scale, showed a trend towards deterioration at 6 mo and a return to preoperative levels at 12 mo. We observed greater variation in scores in all surgical categories in the earlier months, with patients trending towards improved QOL over time. In summary, our strongest findings are as follows: social/family is strongly associated with spiritual and with total QOL scores (both

5 44 JOURNAL OF SURGICAL RESEARCH: VOL. 163, NO. 1, SEPTEMBER 2010 FIG. 2. Wide variation in scores occur in earlier months, but QOL score trends are better as time since surgery increases. FACT-G and FACIT-Sp). Married patients tend to report higher social/family as as higher overall QOL. For most subscales, as as for overall total QOL, patient scores showed large variation at early time points after surgery/treatment and then tend to cluster toward higher QOL values as time since surgery increases. Study Limitations A limitation is that this was a cross-sectional study conducted at one academic medical center. A second limitation is that the FACT-G/FACIT-Sp does not adequately capture physical symptoms and side effects specific to our patient population. A third limitation is that the normative data available for comparison reflect a population with broad cancer diagnoses. A population of upper gastrointestinal cancer survivors not participating in a survivorship clinic would be a more appropriate yardstick for comparison and reduce possible selection bias in terms of patients who choose follow-up in this setting. There are challenges inherent in a study of patientreported health related quality of life. Because personal goals and related constructs play a role in an individual s conception of QOL, the criteria that patients use to anchor ratings of life satisfaction may differ from person to person and from time to time [16]. A person s expectations with regard to his/her health and ability to cope with disabilities can dramatically affect the TABLE 4 Quality of Life Scores by Type of Surgery a Surgery category a n Physical Social/family Emotional QOL scores Functional Spiritual FACT-G total FACIT-Sp total Pancreas Liver Esophagus and gastric Sarcoma Other Total

6 SCHUBART ET AL.: QUALITY OF LIFE ASSESSMENT IN POST-OPERATIVE PATIENTS 45 TABLE 5 Quality of Life Scores Measured by FACIT-Sp and Normative Sample Comparison FACIT-Sp subscale Possible score range Patient mean score (n ¼ 99) Normative data of cancer sample* (n ¼ 2236) Physical Social/family Emotional Functional FACT-G total Spiritual FACIT-Sp total * Brucker et al [13]. perception of health and overall satisfaction with life [17]. Our current study (opened for recruitment in January 2010) will overcome this limitation by capturing baseline quality of life preoperatively, and at multiple, defined intervals postoperatively. This prospective, longitudinal study uses disease specific scales in the FA- CIT family of instruments to more accurately capture physical -, and includes additional instruments that will help us to describe each patient s QOL progression over time. CONCLUSIONS The increasing number of cancer survivors poses a new challenge to clinicians to provide supportive care and address the multifaceted needs of those living with a cancer diagnosis. If they are to optimize psychosocial as as physical outcomes in the posttreatment period, surgeons need to be aware of the problems their patients face and take a proactive stand in understanding their survivorship needs and offering appropriate health services. Few prospective studies have used a validated quality of life instrument in patients undergoing surgery for gastrointestinal malignancies. The results of our evaluation of health related QOL in a sample of 99 patients followed in our GI Survivorship Clinic reveal higher self-reported QOL than those seen in a normative sample of cancer patients. These pilot study results suggest that despite aggressive surgical and medical treatment for malignancies with a generally poor prognosis, cancer survivors treated and followed in a multidisciplinary setting can experience acceptable health-related QOL. Our ongoing studies will test various possible correlates to QOL (such as prognosis and social/family support). An understanding of the components of quality of life from the patient s perspective will help us to provide postoperative follow-up and care in the future that is tailored to the needs of our patients. REFERENCES 1. National Cancer Institute. Estimated U.S. cancer prevalence counts: Who are our cancer survivors in the U.S.? Bethesda, MD: U.S. National Institutes of Health; 2009 [December 15, 2009]; Available from: index.html. 2. National Cancer Institute. Facing forward life after cancer treatment Bethesda, MD: U.S. National Institutes of Health; 2006 [December 15, 2009]; Available from: gov/cancertopics/life-after-treatment. 3. Banz VM, Inderbitzin D, Fankhauser R, et al. Long-term quality of life after hepatic resection: Health is not simply the absence of disease. World J Surg 2009;33: Cella DF. Quality of life: concepts and definition. J Pain Symptom Manage 1994 Apr;9(3): President s cancer panel annual report. Living beyond cancer: Finding a new balance. Bethesda, MD: U.S. Department of Health & Human Services, National Institute of Health, National Cancer Institute. [December 10, 2009]; Available from: vorship.pdf. 6. Hewitt M, Ganz PA, Eds. From cancer patient to cancer survivors. Lost in translation: An American society of clinical oncology and institute of medicine symposium. Washington, DC: The National Academies Press, Alfano CM, Rowland JH. Recovery issues in cancer survivorship: A new challenge for supportive care. Cancer J 2006; 12: Gusani NJ, Schubart JR, Wise J, et al. Cancer survivorship: A new challenge for surgical and medical oncologists. J Gen Intern Med 2009;24(Suppl 2):S Weisbord SD, Carmody SS, Bruns FJ, et al. Symptom burden, quality of life, advance care planning and the potential value of palliative care in severely ill haemodialysis patients. Nephrol Dial Transplant 2003;18: Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 1993;11: Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes 2003;1: Peterman AH, Fitchett G, Brady MJ, et al. Measuring spiritual - in people with cancer: The functional assessment of chronic illness therapy spiritual - scale (FACIT-Sp). Ann Behav Med 2002;24: Brucker PS, Yost K, Cashy J, et al. General population and cancer patient norms for the Functional Assessment of Cancer Therapy-General (FACT-G). Eval Health Prof 2005; 28:192.

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