| Gastrointestinal reactions are the most common toxicity of chemotherapy, which usually manifest with anorexia, nausea, vomiting and other symptoms. These symptoms not only affect the patients'physical function and quality of life, but also influence patients'treatment tolerance, and are closely related with the survival period. The management of gastrointestinal symptoms has always been the focus of medical attention and study. There are still a few problems in the study:?The previous invetigations mostly focused on the phenomenon description and treatment interventions on single symptom, but did not discuss gastrointestinal symptoms as a whole; most concerned only one dimension about symptom occurrence, ignoring the impact on patients'lives in a certain period: not taking symptom burden as a whole concept into the assessment and management of symptoms.?Specific tools needed to be developed for assessing the burden of overall gastrointestinal symptoms during chemotherapy.?Although the prevalence and influence factors of single symptom, such as nausea and vomiting, which is normal in chemotherapy have been investigated, few systemic studies and reports on the occurrence and the distribution of the whole digestive tract symptoms burden, development trends over time and the related influence factors could be found.This study intends to take chemotherapy-related gastrointestinal symptoms burden as a whole, constructing a symptoms inventory including two dimensions-symptoms occurrence and impact, using this tool to analyze the cancer patient's chemotherapy-related gastrointestinal symptoms burden on cross section and investigate the prevalance and distribution of symptoms burden, and taking the further longitudinal study on the symptoms at different time points to explore the chemotherapy-related gastrointestinal symptoms burden's trend and the impact factors at different time for clinical management reference.Part?The Construction and Evaluation of the Tool for Assessing the Chemotherapy–Related Gastrointestinal Symptoms Burden ObjectiveTo construct an assessment tool for the chemotherapy-related gastrointestinal symptoms burden: Chemotherapy-Related Gastrointestinal Symptoms Inventory(CGISI), and evaluate the reliability and validity.MethodsStage one, the item pool was compiled through the literature review on chemotherapy- related gastrointestinal symptoms burden, then being selected, optimized and modified through a research on 79 professional staff who major in Oncology and Digestion, and 63 patients treated with chemotherapy, being developed into the first draft of CGISI-1, containing 21 items. Stage two, taking a cross-sectional study on the chemotherapy-related gastrointestinal symptoms burden of 1116 cases by CGISI-1, analyzing the inventory through the critical ratio, correlation analysis, internal consistent reliability, principal components factor methods, two items of mouth/throat pain and sleep were deleted. The inventory's validity was evaluated through exploratory factor analysis and the factors and total scale correlation matrix structure, diet being deleted as a result. Comparison between the difference of gastrointestinal symptoms burden before and after chemotherapy, and the correlation analysis of symptom inventory and the QLQ-C30 symptom scale were used to to evaluate the criterion validity. The scale reliability was tested by the index of internal consistency reliability coefficients Cronbach?and test-retest reliability. The results are all in line with the target requirements, so 18 items were retained to build the second draft of CGISI-2. The third stage, the third draft of CGISI-3 containing 14 items was formed on the basis of investigating 579 cases of patients by using the CGISI-2 and deleting 4 items including the swallowing discomfort, hiccups, belching, heartburn. The fourth stage, based on the factors of CGISI-3, the data of the second stage was cross-validated. Then the scale structure was proposed through the confirmatory factor analysis of each factor, and finish the construcion of the tool for the assessment of chemotherapy-related gastrointestinal symptoms burden: CGISI .ResultsCGISI consists of symptoms occurrence and symptoms impacts. Symptoms occurrence includes 10 items of gastrointestinal symptoms, to assess the most serious degree of gastrointestinal symptoms within the last 24 hours. Symptoms impact, including four items, was used to assess the influence of gastrointestinal symptoms on patients'lives within the last 24 hours. The 10 symptoms items are divided into two factors: dietary intake factor, which includes 5 items of losing appetite, nausea, vomiting, dysgeusia, acid reflux; and digestion excretion factor, including stomach/abdominal distension, stomach/abdominal pain, dry mouth/throat, constipation, diarrhea. The level of symptom severity is from 0 to 4, which represents none, mild, moderate, much severe, extremely severe. The total score of 10 items ranges from 0 to 40. 0 means no gastrointestinal symptoms. The higher the score was, the more serious the gastrointestinal symptoms indicate. Symptoms impact is divided into 0?4 level, namely "no impact, little impact, some impact, great impact, extreme impact ". The total score ranges 0?16; 0 means no effect on life, higher score indicates greater impact on life. The scale's overall Cronbach?coefficient was 0.887, and the two-dimension Cronbach?coefficients were 0.832 and 0.914, respectively. The two factors's Cronbach?coefficients of the symptoms occurrence dimension were 0.844 and 0.621.ConclusionsCGISI, which has good reliability and validity, can be used as an effective assessment tool for the chemotherapy -related gastrointestinal symptoms burden.Part?: The Prevalance and Distribution of Chemotherapy-Related Gastrointe- stinal Symptoms BurdenObjectiveStudy the overall prevalance and distribution of gastrointestinal symptoms burden in cancer patients after Chemotherapy.MethodsWe analyzed the data of 1116 hospitalized cancer patients under venous chemotherapy with CGISI, which collected by cross-sectional surveying on the gastrointestinal symptom burden to learn the prevalence, the influential rate, the distribution of different levels of sevirity, the relation between symptom occurrence and its effects, and the number of symptoms one patient have concurrently and the common symptoms combination. And we analyzed the features of the symptom occurrence and symptom distribution on genders, age, types of disease and physical status.ResultsThe prevalence of chemotherapy-related gastrointestinal symptoms fluctuates from 8% to 61.1%; the highest is in anorexia, and the lowest is diarrhea, and the mild severity is very common in symptoms distribution degrees. We find that 3.16±2.61 kinds of gastrointestinal symptoms often occur in a patient at the same time; patients with more than 2 kinds of symptoms account 66.5% (742 cases). And Loss of appetite, mouth/throat dry, nausea, dysgeusia, vomiting, constipation are the top six symptoms with the highest occurrence and count the most score. The influences of the symptoms on life were all more than 40%, among which the maximum rate is physical strenth (50.9%), with the highest degree scores (0.93±1.11).The severity score of the following six symptoms, that is, loss of appetite, unusual taste, constipation, diarrhea, mouth/throat dry, stomach/abdominal distension have significant predictive power on the degree of symptoms impact. In the symptom scoring of different genders, females score significantly higher than males. In the group at different ages, the group whose members are in their 30s score the highest, followed by the 40s, and the group whose members are younger than 30 years old group is the lowest; and in the group whose members are aged 30 years old to 70, the score of dietary intake of each factor is apt to decrease with the age increases. Between the different diseases groups, the female reproductive system tumor group score the highest, followed by breast tumor, gastrointestinal tumor, head and neck tumor. Patients in different physical conditions, the poorer physical status have heavier gastrointestinal symptoms burden was; and it is apt to increase with the ECOG score increasing.ConclusionsChemotherapy–related gastrointestinal symptoms are very common, and often with coexistence of multiple symptoms and affect many aspects of patients'life. Hence, clinical attention should be payed to the overall management of chemotherapy-related gastrointestinal symptoms burden. The symptom burden occurrence and distribution are significantly different among gender, age, different tumor type, and physical status of patients. Combining these characteristics, we can do it better to discern high risk group and select key observation patients in clinical symptoms management. Part?Longitudinal Survey on the Gastrointestinal Symptom Burden of Cancer ChemotherapyObjectiveTo explore the entire variation tendency and impact factors of gastrointestinal symptom burden at different time points during chemotherapy.MethodsLongitudinal survey on the gastrointestinal symptom burdens during chemotherapy was performed on 631 hospitalized patients with CGISI to know the overall tendency of symptom burden at different time. The 1st day and 5th day were the repeated measurement time points, while the types of diseases and chemotherapy programs were addressed to be treatment factors. Repeated measure of variance analysis was conducted on the symptom occurring dimensionality and symptom impact dimensionality in 356 cases to explore the time effect of symptom burden. Symptom burden at different time point was measured as response variable, while 16 impact factors as independent variables. Multivariate analysis was conducted to understand the impact factors of symptom burden.ResultsSymptom burden entirely changed wavily with the time. The lowest is on day 1, while symptom increased on day 2 to day 5, and it began to fall on the day 6 and day 7. In various symptoms, abnormal taste, mouth/throat dry, stomach/abdominal pain, stomach/abdominal distension, diarrhea, physical impact continued to increase on day 7. Repeated measures of variance analysis showed that time variation trends existed significantly in symptom occurring and impact dimensions. Time and types of diseases had significant interaction effect, while time and chemotherapy programs types of diseases and chemotherapy had no interaction effects. Finally, multivariate analysis of variance showed that six significant factors on gastrointestinal symptoms burden at different time points are types of diseases, physical performance, degree of gastrointestinal symptoms during pregnancy, tension degree about chemotherapy, gastrointestinal symptoms in former drug usage, whether having other gastrointestinal tract diseases. In types of diseases, the malignant melanoma, colorectal cancer, gastric cancer patients had the highest scores of the symptom occurring dimensions, while female reproductive system symptoms had the highest scores in symptom impact dimensions. Patients, with poor physical performance, high gastrointestinal reactions during pregnancy, high degree of intense about chemotherapy, heavy gastrointestinal reaction in previous drug usage, having other gastrointestinal diseases, have significantly higher symptom burden than patients in other groups.ConclusionsGastrointestinal symptom burden at different time points during chemotherapy changed significantly, with the wavy trend entirely. But the development pathway of different symptoms was not exactly same. The significant factors on gastrointestinal symptoms burden at different time points are types of diseases, physical performance score, degree of gastrointestinal symptoms during pregnancy, tension degree about chemotherapy, gastrointestinal symptoms in former drug usage, whether having other gastrointestinal tract diseases. Management of clinical symptoms should be combined with the time trends and impact factors to formulate pertinence management programs according with time. |
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