Preparedness for colorectal cancer surgery and recovery through a person-centred information and communication intervention - A quasi-experimental longitudinal design.

To meet patients' information and communication needs over time in order to improve their recovery is particularly challenging for patients undergoing cancer surgery. The aim of the study was to evaluate whether an intervention with a person-centred approach to information and communication for patients diagnosed with colorectal cancer undergoing surgery can improve the patients' preparedness for surgery, discharge and recovery during six months following diagnosis and initial treatment. The intervention components involving a novel written interactive patient education material and person-centred communication was based on critical analysis of conventional information and communication for these patients. During 2014-2016, 488 consecutive patients undergoing elective surgery for colorectal cancer were enrolled in a quasi-experimental longitudinal study. In three hospitals, first a conventional care group (n = 250) was recruited, then the intervention was introduced, and finally the intervention group was recruited (n = 238). Patients' trajectories of preparedness for surgery and recovery (Preparedness for Colorectal Cancer Surgery Questionnaire-PCSQ) health related quality of life (EORTC QLQ-C30) and distress (NCCS Distress Thermometer) were evaluated based on self-reported data at five time points, from pre-surgery to 6 months. Length of hospital stay and patients' behavior in seeking health care pre- and post-surgery were extracted from patient records. Longitudinal structural equation models were used to test the hypothesized effects over time. Statistically significant positive effects were detected for two of the four PCSQ domains (patients searching for and making use of information, and making sense of the recovery) and for the role functioning domain of the EORTC QLQ-C30. Patients in the intervention group were also more likely to contact their assigned cancer "contact nurse" (a.k.a. nurse navigator) instead of contacting a nurse on duty at the ward or visiting the emergency department. In conclusion, the overall hypothesis was not confirmed. Further research is recommended on written and oral support tools to facilitate person-centred communication.

Case Mix Difference Can Affect Evaluation of Outcome of Treatment for Colorectal Cancer.

AIM: To explore the potential effects of patient selection, for example by organization, on survival as outcome parameter in colorectal cancer treatment. PATIENTS AND METHODS: The main cohort was identified in a Hospital-based registry and outcome data of all 2,717 patients operated on for colorectal cancer between 2000-2011 were evaluated. A simulation of different center settings was performed using several potential selection criteria, including emergency cases, referral surgery and palliative resection, and used for comparison of outcome data. RESULTS: Overall survival and cancer-specific survival can be significantly affected in both short-term (30-/90-day) mortality and long-term survival by factors of organizational level. CONCLUSION: Survival data as an outcome parameter can be affected by the composition of the patient cohort and thus reflect possible selection bias for example due to organization, referral patterns and practice customs. This potential bias should be acknowledged when making inter-hospital comparisons of outcome.

A pharmacokinetic and pharmacodynamic investigation of Modufolin® compared to Isovorin® after single dose intravenous administration to patients with colon cancer: a randomized study.

PURPOSE: Leucovorin is commonly used as folate supplement in 5-fluorouracil-based chemotherapy, but needs to be converted to active 5,10-methylenetetrahydrofolate (methyleneTHF) intracellularly. This provides for interindividual differences. MethyleneTHF has recently been developed into the stable, distributable drug, Modufolin®. The aim was to compare the concentration of folate metabolites in tumor, mucosa, and plasma of patients with colon cancer after administration of Modufolin® or Isovorin® (levo-leucovorin). METHODS: Thirty-two patients scheduled for colon resection were randomized to receive Modufolin® or Isovorin® at dosage of 60 or 200 mg/m². The study drug was given as one i.v. bolus injection after anesthesia. Plasma was collected for pharmacokinetic (PK) analysis before, during, and after surgery. Tissue biopsies were collected at surgery. Folate metabolites were analyzed by LC-MS/MS. RESULTS: MethyleneTHF and THF concentrations were significantly higher in mucosa (p < 0.01, both dosages) and tumors (p < 0.01, 200 mg/m²) after Modufolin® as compared to Isovorin® administration. The results correlated with PK observations. The Modufolin® to Isovorin® C(max) ratio for methyleneTHF was 113 at 200 mg/m² and 52 at 60 mg/m²; the AUC(last) ratios were 17 and 9, respectively. The THF plasma concentrations were also higher after Modufolin® administration (C(max) ratio 23, AUC(last) ratio 13 at 200 mg/m²; C(max) ratio 15, AUC(last) ratio 11 at 60 mg/m²). CONCLUSION: Modufolin® administration resulted in significantly higher methyleneTHF levels than Isovorin® and may potentially increase the efficacy of 5-fluorouracil-based chemotherapy. The results encourage further evaluation of Modufolin® as a substitute to Isovorin® including the potential clinical benefits.

A population-based cohort study on adherence to practice guidelines for adjuvant chemotherapy in colorectal cancer.

BACKGROUND: The value of adjuvant chemotherapy in colorectal cancer is well studied, and guidelines have been established. Little is known about how treatment guidelines are implemented in the everyday clinical setting. METHODS: This national population-based study on nearly 34,000 patients with colorectal cancer evaluates the adherence to present clinical guidelines for adjuvant chemotherapy. Virtually all patients with colorectal cancer in Sweden during the years 2007-2012 and data from the Swedish Colorectal Cancer Registry were included. RESULTS: In colon cancer stage III, adherence to national guidelines was associated with lower age, presence of multidisciplinary team (MDT) conference, low co-morbidity, and worse N stage. The MDT forum also affected whether or not high-risk stage II colon cancer patients were considered for adjuvant chemotherapy. Rectal cancer patients both in stage II and III were considered for adjuvant chemotherapy less often than colon cancer patients, but the same factors influenced the decision. Adjuvant chemotherapy was started later than eight weeks after surgery in 30% of colon cancer patients and in 38% of rectal cancer patients. CONCLUSIONS: In Sweden, the adherence to national guidelines for adjuvant chemotherapy in colon cancer stage III is acceptable in younger and healthier patients. MDT conferences are of major importance and affect whether patients are recommended for adjuvant chemotherapy. Special consideration needs to be given to certain subgroups of patients, particularly older patients and patients with poorly differentiated tumors. There is a need to shorten the waiting time until start of chemotherapy.

A survey of surgeons' perception and awareness of intraoperative time utilization.

BACKGROUND: Surgical teams' awareness of the time needed to perform specific phases of a surgical procedure is likely to improve communication in the operating theatre and benefit patient safety. The aim of this study was to assess surgeons' awareness of time utilization and the actual time needed to perform specific phases of an operation. METHODS: A survey was conducted to examine the method and design for a larger study. Interviews were conducted with 18 surgeons, and surgical time was measured during 21 colon cancer resections. Correlation analyses were performed to explore the factors that might affect operating time. RESULTS: The surgical phase with the greatest variation in time was dissection/resection (43-308 minutes). On a group level, no statistically significant differences were found between estimated and measured surgical procedural times for partial or full resections (160.4 versus 173.0 minutes, p = 0.539). However, interindividual variation was substantial. There was a positive significant correlation between long duration of dissection/resection and longer time to close the abdomen (r = 0.464, p = 0.039), as well as between long duration of a hand-sewn anastomosis and time needed to close the abdomen (r = 0.536, p = 0.018). CONCLUSIONS: It can be difficult for a single surgeon to estimate the time required for a partial or full surgical procedure. A larger study might provide additional time estimates and identify variables that affect surgical time. The data could be of interest in the planning and scheduling of surgical resources, thus improving theatre team communication and patient safety.

Readability, suitability and comprehensibility in patient education materials for Swedish patients with colorectal cancer undergoing elective surgery: a mixed method design.

OBJECTIVE: To characterize education materials provided to patients undergoing colorectal cancer surgery to gain a better understanding of how to design readable, suitable, comprehensible materials. METHOD: Mixed method design. Deductive quantitative analysis using a validated suitability and comprehensibility assessment instrument (SAM+CAM) was applied to patient education materials from 27 Swedish hospitals, supplemented by language technology analysis and deductive and inductive analysis of data from focus groups involving 15 former patients. RESULTS: Of 125 patient education materials used during the colorectal cancer surgery process, 13.6% were rated 'not suitable', 76.8% 'adequate' and 9.6% 'superior'. Professionally developed stoma care brochures were rated 'superior' and 44% of discharge brochures were 'not suitable'. Language technology analysis showed that up to 29% of materials were difficult to comprehend. Focus group analysis revealed additional areas that needed to be included in patient education materials: general and personal care, personal implications, internet, significant others, accessibility to healthcare, usability, trustworthiness and patient support groups. CONCLUSION: Most of the patient education materials were rated 'adequate' but did not meet the information needs of patients entirely. Discharge brochures particularly require improvement. PRACTICE IMPLICATIONS: Using patients' knowledge and integrating manual and automated methods could result in more appropriate patient education materials.

Long-term follow-up after preoperative chemotherapy using pemetrexed (Alimta) in rectal cancer.

AIM: To assess the long-term outcome in a cohort of patients treated with preoperative chemotherapy using pemetrexed (Alimta) for rectal cancer. PATIENTS AND METHODS: A prospective phase I/II study on preoperative chemotherapy using Alimta was conducted during 2006-2008. The long-term outcome was assessed here for both the study group (n=37) and the reference group (n=87). The focus was on cancer recurrence and survival with consideration of initial tumour stage and treatment response. RESULTS: There was one recurrence, each in stages I and II and three (23.1%) in stage III in the Alimta-treated group. One patient remains disease, free after surgery for metastasis. Patients with more symptoms remaining after treatment had a higher risk of recurrence. CONCLUSION: The initial Alimta study concluded that treatment was feasible in rectal cancer with significant reductions in tumour symptoms and size. The long-term outcome is acceptable and does not provide evidence against the concept of preoperative chemotherapy using Alimta.

Age aspects of demography, pathology and survival assessment in colorectal cancer.

AIM: The aim of this study was to assess how age is related to differences in stage, tumour differentiation and treatment in colorectal cancer. PATIENTS AND METHODS: A retrospective study in a consecutive series of colorectal cancer patients (n = 2220) where age was related to demography, stage, tumour characteristics, treatment and outcome (OS/CSS) both as a continuous variable and grouped by high/low 10th percentiles, as young/old groups, with a third median reference group. RESULTS: Young patients had more advanced cancer stages (p = 0.012), higher N-status (p = 0.011) and more frequent T4/G4 tumours. Old patients had higher postoperative mortality and were less likely to receive chemotherapy. The proportion of cancer-related deaths was stage-dependent and decreased with age. CONCLUSION: Cancer stage, tumour characteristics, treatment and outcome can vary with age in colorectal cancer. The increasing proportion of non-cancer deaths at a higher age can affect the use of overall survival as an outcome parameter, which may be of importance in evaluating clinical and translational research.

Tumour differentiation grade is associated with TNM staging and the risk of node metastasis in colorectal cancer.

AIM: The tumour differentiation grade has been shown by numerous multivariate analyses to be a stage-independent prognostic factor in colorectal cancer. The aim of this study was to explore the importance of differentiation grading for the staging of colorectal cancer and how it relates to the components of the TNM system. MATERIAL AND METHODS: The study was a retrospective single-centre analysis of all patients undergoing surgical resection for colorectal cancer during the period 2002-2007 (n = 1239). The clinical parameters and pathology data of overall stage, differentiation grade, local tumour (T)-stage and metastasis status (M-stage) were included as well as the lymph node count of both assessed and metastatic nodes. The differentiation grade was correlated with demography, overall stage and each component of the TNM staging system. The correlation between differentiation grade and N-stage was also explored for the separate T-stages. RESULTS: The tumour differentiation grade correlated significantly with the overall TNM stage (p < 0.0001). The grade significantly correlated with the T-stage and the risk of having lymph node metastasis (p < 0.0001). A high grade was associated with a higher positive lymph node count in stage III disease (p < 0.0002). For the T-stages, the risk of node metastasis was significantly linked to the tumour grade. A low grade (G1) T2 had a 17% risk of lymph node metastasis compared to a 44% risk for a high grade (G4) T2. CONCLUSION: Tumour differentiation is an important prognostic factor. It correlates significantly with the overall stage of the TNM system and also to each of its components. The risk of having lymph node metastasis for each T-stage also correlates with the tumour grade. The findings can be of importance in postoperative risk assessment or when considering local resection procedures like TEM.