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Methods: This nested, prospective, longitudinal, exploratory study was conducted within a randomized, double-blind, placebo-controlled clinical trial (parent study). The purpose of the parent study was to evaluate the safety and effectiveness of an intraoperative celiac nerve block (ethanol celiac plexus neurolysis) in patients undergoing surgery for pancreas or periampullary cancers, between 2008 to 2013 (Lavu et al., 2015). One hundred and forty-three patients undergoing surgery for stage II PC were identified through the parent study located at a National Cancer Institute (NCI)-designated cancer center in the northeastern United States. The Theory of Unpleasant Symptoms (Lenz & Pugh, 2008) served as the theoretical framework for this study. Symptom and QoL data were measured by the Functional Assessment in Cancer Therapy: Hepatobiliary Cancer Tool (Heffernan et al., 2002) preoperatively and at 3, 6, and 9 months postoperatively. Deaths were confirmed through the Social Security’s Online Death Index, online news reports (obituaries), or through family reports. Survival data were collected from the date of surgery until last follow-up or time of death, which ranged from 3 months to 60 months. Statistical methods included simple linear regression, Cox proportional hazards regression, and Kaplan-Meier survival analyses.
Results: The mean age of patients in this study was 67.3 ± 10.4 years (44.0 – 86.0). Most patients were White (90.2%), male (57.3%), and married or living with their partner (75%). All patients had Stage IIa or IIb PC using the American Joint Committee on Cancer (AJCC) 7th edition Tumor-Node-Metastasis Cancer Staging System (AJCC, 2009) and underwent surgical resection, most often a pylorus-preserving pancreaticoduodenectomy (pylorus sparing Whipple procedure) (64.0%) or pancreaticoduodenectomy (classic Whipple procedure) (21.7%). Eighty-two percent of patients also received adjuvant chemotherapy or chemoradiation therapy or had neoadjuvant therapy (7%). The overall questionnaire response rates for this study were 100% (n=143) preoperatively and 76% (n=109) at 3 months, 64% (n=92) at 6 months, and 62% (n=89) at 9 months postoperatively.
Significant relationships were found between increased severity of 13 of 16 SCs identified and decreased QoL (all p-values <0.05), which included 3 SCs at preoperative baseline (Pain-Gastrointestinal SC, Mood SC, and Fatigue-Nutritional Problems SC); and 3 SCs at 3 months (Mood-Pain-Anorexia-Fatigue SC, Insomnia-Digestive Problems SC, and Nutritional Problems SC); 4 SCs at 6 months (Mood-Pain-Insomnia SC, Bowel-Digestive Problems SC, Fatigue-Anorexia-Nutritional Problems SC, and Pain-Itching SC); and 3 SCs at 9 months postoperatively (Mood-Insomnia-Pain-Nausea SC, Digestive-Weight Loss-Bowel Problems SC, and Fatigue-Pain-Nutritional Problems SC).
Only 2 of the 16 SCs identified in this study were associated with survival, which included the Insomnia-Digestive Problems SC and Nutritional Problems SC at 3 months postoperatively. More specifically, at three months postoperatively, PC patients who reported high severity of the Insomnia–Digestive SC (loss of bowel control, trouble digesting food, and trouble sleeping) were found to have a 60% higher hazard of dying (HR 1.60, 95% CI [1.08, 2.36], p<0.05) and PC patients who reported high severity of the Nutritional Problems SC (weight loss, change in taste, dry mouth, and itching) were at a 53% higher hazard of dying (HR 1.53, 95% CI [1.06, 2.22], p<0.05) when compared to PC patients who experienced a low severity of these SCs. Furthermore, postoperative PC patients who experienced increased severity of the Insomnia–Digestive Problems SC at 3 months postoperatively demonstrated poorer median survival (14.3 months, 95% CI [11.2, 17.3]) when compared to survival of postsurgical PC patients who experienced lower severity of this SC (22.5 months, 95% CI [16.3, 30.0], p<0.05). Similarly, postoperative PC patients who experienced increased severity of the Nutritional Problems SC at 3 months postoperatively demonstrated poorer median survival (14.4 months, 95% CI [12.2, 18.7]) than postsurgical PC patients who experienced lower severity of this SC (19.8 month, 95% CI [15.5, 28.8], p<0.05). These exploratory outcome data must be cautiously interpreted as there was no adjustment for the presence of other potentially influential factors.
Conclusion: Findings suggest that 13 SCs identified over time were associated with decreased QoL and that 2 of these SCs when present at 3 months postoperatively were potentially associated with reduced survival. The clinical outcomes examined in this study provided support of the detrimental effects that increased severity of SCs may have on postoperative patients with PC. The findings from this study may be used by oncology nursing professionals to provide anticipatory guidance and help inform the assessment of SCs in patients with PC. Furthermore, these findings underscore the important role that SC assessments may have in identifying those patients who have an increased risk for poor clinical outcomes. While causality cannot be determined between the SCs and clinical outcomes in this exploratory study, these potentially important associations deserve further investigation with a more targeted and detailed analysis involving a larger cohort. As such, this study provides a framework for further investigation into the role that adverse symptoms and symptoms clusters play in QoL and survival in this population.