Assessment of peri-operative quality of life in patients undergoing surgery for gastrointestinal cancer

The purpose of this study was to assess the pre- and postoperative quality of life (QOL) of patients with gastrointestinal cancer and to investigate the relationship between QOL and various psychological and clinical factors. Eighty-five patients who underwent surgery for gastrointestinal cancer and 26 control patients undergoing surgery for digestive diseases other than cancer were interviewed. Two tests were administered to assess QOL and psychological status respectively: the Japanese-language version of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the Japanese-language version of the Hospital Anxiety and Depression Scale (HADS). Each test was administered before surgery, before discharge, and 6 months after discharge. Gastrointestinal tumors were localized to the stomach, colon, or rectum in 88% of cases and classified as advanced stage or early stage according to staging protocols. Changes in EORTC QLQ-C30 subscale scores over time were compared among advanced stage, early stage, and control patients. All groups showed significant changes in subscale scores of QOL; the scores of the advanced-stage group indicated worse QOL than the early-stage and control groups in a lot of areas. The physical function (PF2) QOL subscore was influenced by diagnosis, postoperative complications, medical equipment at discharge, and the length of admission and negatively correlated with depression and anxiety. These results suggest that QOL in gastrointestinal cancer patients is variable over time and is influenced by various clinical factors. Therefore, consideration of these clinical factors is paramount to the optimal care of gastrointestinal cancer patients.     

Minimal Clinically Important Difference for the Rasch Neuropsychiatric Inventory Irritability and Aggression Scale for Traumatic Brain Injury

Objective

To determine the minimal clinically important difference (MCID) for a Rasch measure derived from the Irritability/Lability and Agitation/Aggression subscales of the Neuropsychiatric Inventory (NPI)—the Rasch NPI Irritability and Aggression Scale for Traumatic Brain Injury (NPI-TBI-IA).

Quality of life during clinical trials: conceptual model for the Lung Cancer Symptom Scale (LCSS)

To appreciate the full benefits of treatment for lung cancer, especially in trials that fail to show improvements in survival, data recording the quality of life must be captured and refined to produce meaningful information. A conceptual model for quality of life for lung cancer patients was tested to obtain information about the dimensions of the quality-of-life construct for ongoing development and testing of a subjective measure for clinical trials. Using a longitudinal study design, the stability of predictive factors of the physical and functional dimensions of quality of life were examined using regression analysis. A patient-rated quality-of-life measure, the Lung Cancer Symptom Scale (LCSS), was administered to 144 non-smallcell lung cancer patients at baseline, day 29, and day 71 of a chemotherapy trial. The range of explained variance for all three components of the lung cancer model over three assessment points was as follows: symptomatic distress 41%–53%, activity status 48%–52%, and overall quality of life 35%–53%. The three dimensions fluctuated slightly during intervention, but were relatively stable factors across all three times of evaluation. The LCSS model explained nearly half of the variance for quality of life experienced by lung cancer patients during therapy with a new chemotherapeutic agent. These findings provide support that the physical and functional dimensions are important predictors of quality of life for individuals with lung cancer. Meaningful subjective quality-of-life data can be obtained to evaluate an intervention by using a disease-and sitespecific quality-of-life measure for individuals with lung cancer, based on a reproducible conceptual model such as the LCSS, which is suitable for serial measurement for the progressive disease of lung cancer.     

Efficacy of Exercise Interventions in Patients With Advanced Cancer: A Systematic Review

Objective

To critically analyze the literature surrounding the efficacy of exercise interventions in patients with advanced cancer.

Responsiveness and Minimal Clinically Important Difference of the Motor Function Measure in Collagen VI-Related Dystrophies and Laminin Alpha2-Related Muscular Dystrophy

ObjectivesTo investigate the responsiveness of the motor function measure (MFM) and determine the minimal clinically important difference (MCID) in individuals with 2 common types of congenital muscular dystrophy (CMD).DesignObservational, prospective, single center, cohort study.SettingNational Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH).ParticipantsIndividuals (N=44) with collagen VI-related dystrophies (COL6-RD, n=23) and 21 individuals laminin alpha2-related muscular dystrophy (LAMA2-RD, n=21) enrolled in a 4-year longitudinal natural history study.InterventionsNot applicable.Main Outcome MeasuresResponsiveness of the MFM-32 and the Rasch-scaled MFM-25 and the MCID of the MFM-32 determined from a patient-reported anchor with 2 different methods, within-patient and between-patient.ResultsThe original MFM-32 and Rasch-scaled MFM-25 performed similarly overall in both the COL6-RD and LAMA2-RD populations, with all subscores (D1, standing and transfers; D2, axial and proximal; D3, distal) showing a significant decrease over time, except MFM D1 and D3 for LAMA2-RD. The MFM D1 subscore was the most sensitive to change for ambulant individuals, whereas the MFM D2 subscore was the most sensitive to change for nonambulant individuals. The MCID for the MFM-32 total score was calculated as 2.5 and 3.9 percentage points according to 2 different methods.ConclusionsThe MFM showed strong responsiveness in individuals with LAMA2-RD and COL6-RD. Because a floor effect was identified more prominently with the Rasch-Scaled MFM-25, the use of the original MFM-32 as a quantitative variable with the assumption of scale linearity appears to be a good compromise. When designing clinical trials in congenital muscular dystrophies, the use of MCID for MFM should be considered to determine if a given intervention effects show not only a statistically significant change but also a clinically meaningful change.     

N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2): A Double-Blind Randomized Clinical Trial

ObjectiveTo determine whether N-acetylcysteine rinse was safe and could improve thickened secretions and dry mouth during and after radiotherapy.Patients and MethodsWe designed a prospective pilot double-blind, placebo-controlled randomized clinical trial (Alliance MC13C2). Adult patients (age ≥18 years) were enrolled if they underwent chemoradiotherapy (≥60 Gy). Patients initiated testing rinse within 3 days of starting radiotherapy. With swish-and-spit, they received 10% N-acetylcysteine (2500 mg daily) or placebo rinse solution 5 times daily during radiotherapy and 2 weeks postradiotherapy. The primary aim was to evaluate N-acetylcysteine in improvement of saliva viscosity with the Groningen Radiotherapy-Induced Xerostomia questionnaire. Secondary aims included evaluating xerostomia improvement by the same questionnaire and with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Head and Neck-35 Questions survey and adverse-event profiles. The type I error rate was 20%.ResultsThirty-two patients undergoing chemoradiotherapy were enrolled. Baseline characteristics were balanced for placebo (n=17) and N-acetylcysteine (n=15). N-acetylcysteine was better for improving sticky saliva (area under curve, P=.12). Scores of multiple secondary end points favored N-acetylcysteine, including sticky saliva daytime (P=.04), daytime and total xerostomia (both P=.02), pain (P=.18), and trouble with social eating (P=.15). Repeated measures models confirmed the findings. Taste was a major dissatisifer for N-acetylcysteine rinse; however, both testing rinses were safe and well tolerated overall.ConclusionOur pilot data showed that N-acetylcysteine rinse was safe and provided strong evidence of potential efficacy for improving thickened saliva and xerostomia by patient-reported outcome. A confirmatory phase 3 trial is required.Trial Registrationclinicaltrials.gov Identifier: NCT02123511