| Objectives:1.To explore the dynamic characteristics,mutual relationship and core symptoms of perioperative symptoms in patients with gastrointestinal cancer,and to probe the influencing factors and related outcomes of symptom;2.To construct a self-help mindfulness intervention program for perioperative symptom management of gastrointestinal cancer patients;3.To verify the effect of self-help mindfulness intervention on perioperative symptoms.Methods:Part Ⅰ:Dynamic characteristics of perioperative symptoms and its influencing factors and outcomes in patients with gastrointestinal cancerA longitudinal study was conducted in 241 surgical gastrointestinal cancer patients at hospital in China.The measurement points included T0(2 days before surgery),T1(2 days after surgery),T2(6 days after surgery),T3(10 days after surgery)and T4(14 days after surgery).Measurement tools included M.D.Anderson Symptoms Inventory-Gastrointestinal cancer Module(MDASI-GI),Perceived Social Support Scale(PSSS),Brief Illness Perception Questionnaire(BIPQ),Neuroticism Subscale of the Big Five Inventory(BFI-N),Quality of Recovery-15(QoR-15)and Stress Response Questionnaire(SRQ).The main statistical analysis included Latent Growth Curve Model(LGCM),Gaussian network Model,Multilevel Vector Autoregressive Model(mlVAR),regression analysis and Generalized estimation equation(GEE).Part Ⅱ:Construction of a self-help mindfulness intervention program for perioperative symptoms management in patients with gastrointestinal cancerFirst,we constructed a draft intervention program based on mindfulness Monitor and Acceptance Theory(MAT),results of meta-analysis and longitudinal observational study.Second,the intervention program was revised by expert consultation and pre-experiment.The theme of Meta-analysis is to clarify the effect of mindfulness intervention on perioperative symptoms.RevMan 5.3 software was used to perform statistical analysis.The preliminary trial was a Randomized Controlled Trial(RCT)in 24 patients with gastrointestinal cancer who were undergoing surgery.The outcome indicators included the feasibility,acceptability and effectiveness of the intervention.Part Ⅲ:Test of the self-help mindfulness intervention program for perioperative symptoms management in patients with gastrointestinal cancerA RCT was conducted to examine the effects of self-help mindfulness intervention.The implementation process follows the principles of randomization,allocation hiding and blinding.A total of 328 pariticipants were recruited and randomly assigned to the intervention or control group,with 164 people in each group.The control group received routine health education,and the intervention group received the self-help mindfulness training program on the basis of routine education.The time points of measurement included baseline(T0,2 days before surgery),intervention period(T1,2 days after surgery and T2,6 days after surgery),immediately after intervention(T3,10 days after surgery),and follow-up after intervention(T4,14 days after surgery).The measurement tools included MDASI-GI,BIPQ,BFI-N,SRQ,and QOR-15.The main statistical analysis included GEE,NIA,NCT,and ml VAR.Results:1.Part Ⅰ:Dynamic characteristics of perioperative symptoms and its influencing factors and outcomes in patients with gastrointestinal cancer(1)Core symptoms in symptom network of patients with gastrointestinal cancer during perioperative periodA total of 241 participants were included at T0.The average age of the subjects was 61.15± 11.38 years old;68.9%of the patients were male.The loss rate at T1 was 8.3%,T2 was 14.1%,T3 was 29.5%,and T4 was 12.0%.The LGCM found that the total symptom scores in perioperative period showed a nonlinear trend,and the mean values of quadratic slope factor was-1.623(Ps<0.05).The mlVAR was used to construct temporal network and contemporaneous network of perioperative symptoms based on time series data of five time points.The results of temporal network showed:dry mouth had the strongest out-strength centrality and its vaule was 2.594.The results of contemporaneous network showed:depression was a core symptom with highest strength centrality and its vaule was 1.554.Furthermore,gaussian network model found that the most core symptoms of the perioperative symptom network at five time points were appetite loss,distress,distress,distress,depression,and the intensity centrality was 0.943,1.225,1.057,0.858,1.238,respectively.(3)Influencing factors and related outcomes of perioperative symptoms in patients with gastrointestinal cancerMultivariate analysis based on GEE showed that exercise habit(Waldχ~2=4.341,P=0.037),surgical method(Waldχ~2=6.397,P=0.011)and illness perception(Waldχ~2=286.788,P<0.001)were the main influencing factors for perioperative symptom.LGCM-based regression analysis indicated that the intercept factor of symptom trajectory had an effect on length of stay(β=-0.471,P=0.004),adaptation status(β=1.171,P<0.001),and quality of recovery(β=-1.010,P<0.001).The slope factor of symptom trajectory predicted adaptation status(β=3.611-11.832,Ps≤0.005)and recovery quality(β=-12.569-2.918,Ps≤0.014),but had no effect on length of stay(β=0.024-0.130,Ps=0.893-0.994).2.Part Ⅱ:Construction of a self-help mindfulness intervention program for perioperative symptoms management in patients with gastrointestinal cancer(1)Formulation of the draft intervention programA total of 909 literatures were retrieved through domestic and foreign databases,and finally 8 literatures remained after screening.Meta-analysis showed that mindfulness intervention had improvement effect on perioperative symptoms[SMD=-1.01～-0.33,95%CI=(-1.80～-0.61,-0.51～-0.04)].Then,based on MAT,results of meta-analysis and longitudinal observational study were combined to construct a draft intervention program.Two rounds of expert consultation were conducted on the draft intervention program.The response rate of the first round and the second round was 100%and 77%,respectively.The intervention program was formed after modification according to experts’ suggestions.The results of the preliminary test showed that the questionnaire completion rate of the intervention group was 100%,the compliance was 92%,and the satisfaction of the intervention was 8.08±1.24 points(0-10 points),and intervention had an effect on perioperative symptoms(t=2.294,P=0.032),indicating that the program was feasible and acceptableThe final intervention program included four themes:"Understanding mindfulness","Manageing symptom","Promoting recovery" and "Accepting disease".The first face-to-face pilot course was conducted at 2 days before surgery,and the second to seventh self-help formal courses were conducted at 1 day before surgery to 9 days after surgery.3.Part Ⅲ:Test of the self-help mindfulness intervention program for perioperative symptoms management in patients with gastrointestinal cancer(1)Comparison of baseline data between the intervention group and control groupA total of 328 participants met the study requirements at baseline and 164 in each group after randomization.The average age of the intervention group was 58.80±10.63 years old,and that of the control group was 60.19±11.73 years old.The proportion of males in the intervention group and the control group was similar,67.1%and 68.3%,respectively.There was no significant difference in the general information and main variables between the two groups(Ps>0.05).The attrition rates of intervention group and control group at T1 were 4.9%and 9.1%,respectively.The attrition rates of intervention group and control group at T2 were 7.9%and 16.5%,respectively.The attrition rates of intervention group and control group at T3 were 18.9%and 34.1%,respectively.The attrition rates of intervention group and control group at T4 were 9.1%and 15.2%,respectively.(2)The effect of self-help mindfulness intervention on perioperative symptomsThe GEE showed that the interaction effect of group and time of total symptom scores was statistically significant(Waldχ~2=12.768;Ps=0.012),and the effect size of intervention was moderate(Cohen’s d=0.453).Moreover,the interaction effects of group and time of drowsiness,dry mouth,distress,appetite loss,depression,dysphagia and appetite change were statistically significant(Waldχ~2=10.806-26.040;P≤0.029).Comparing the two groups of temporal network found that intervention could lower the out-strength centrality of dry mouth(Vaulecontrol=3.085,Vauleintervention=1.263).Then,comparing the two groups of contemporaneous network found that the intervention could reduce the strength centrality of dry mouth(Vaulecontrol=1.266,Vauleintervention=1.168)and depression(Vaulecontol=1.213,Vauleintervention=0.944).The NCT showed that there were differences between the two groups in the network structure(M=0.578,P<0.001)and edge strength(C=0.269,P=0.038)at T1.There was no difference in symptom network between the two groups at T2.There was a difference in network structure between the two groups at T3(M=0.405,P=0.013).There was a difference in the network strength between the two groups at T4(S=2.352,P=0.045).The NIA found that there were 12 target symptoms at T1,such as dry mouth(EW=0.231,P<0.05).There were 6 target symptoms at T2,such as dry mouth(EW=0.128,P<0.05).There were 9 target symptoms at T3,such as restless sleep(EW=0.202,P<0.05).There were 6 target symptoms at T4,such as pain(EW=0.180,P<0.05).2)The effects of self-help mindfulness intervention on short-term outcomes and illness perceptionThe results showed that there were significant differences in the length of stay(t=2.634,P=0.009),quality of recovery(t=-3.231,P=0.001)and adaptation status(t=4.922,P<0.001)between the two groups.The GEE found that the interaction effect of group and time of illness perception was statistically significant(Waldχ~2=29.928;P<0.001).Conclusion:1.The perioperative symptoms of patients with gastrointestinal cancer show a non-linear trend.There are positive correlations and predictive effects between most symptoms,among which depression have the strongest correlation with other symptoms,and dry mouth have the strongest predictive effect on other symptoms.2.The influencing factors of perioperative symptom includes exercise habit,surgical method and illness perception;related outcomes of symptom includes quality of recovery and adaptation status,and length of stay.3.The self-help mindfulness intervention program constructed in this study includes four themes:"Understanding mindfulness","Manageing symptom ","Promoting recovery" and"Accepting disease".It is an effective clinical treatment for perioperative symptoms of gastrointestinal cancer patients and has certain feasibility and acceptability.4.Self-help mindfulness intervention can effectively alleviate the severity of perioperative symptoms experience,weaken the correlations among symptoms,improve the quality of recovery,promote good adaptation and shorten the length of stay. |
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