| Patients with Non-Small Cell Lung Cancer(NSCLC)often experience a series of co-occurring symptoms in the perioperative period,which exist in the form of symptom clusters,seriously affecting the quality of life and functional status of patients.Studies have shown that non-pharmacological interventions can effectively reduce patients’ symptom clusters and improve quality of life and functional status.The limited studies on the intervention of perioperative symptom clusters in patients with lung cancer only focus on a certain symptom cluster,and have not yet combined the pathogenesis of symptom clusters with the construction and evaluation of intervention programs.The development and implementation of a scientific and effective symptom cluster intervention program throughout the perioperative period has become an urgent issue in the study of perioperative supportive care for patients with NSCLC.Objectives Based on the dynamic symptom model and the individual and family selfmanagement theory model,combined with the manifestations of perioperative symptom clusters of NSCLC patients explored by the previous research group,the best evidence of symptom cluster intervention was summarized through evidencebased literature,and effective intervention strategies were extracted by combining the biological psychosocial mechanism of the biological correlation of symptom clusters.The perioperative symptom clusters intervention program for NSCLC patients was constructed and implemented clinically,and the effect and mechanism of the program on the effect indicators including symptom cluster severity,function status and quality of life,as well as related biological and psychosocial indicators were explored.Ultimately,it aims to provide clinical practice programs to promote perioperative psychosocial rehabilitation of patients with NSCLC.Methods1.First of all,based on the longitudinal development track of perioperative symptom clusters of patients with NSCLC verified by our research group,the content of symptom clusters requiring intervention was determined.Secondly,guidelines and related literature on symptom management of patients with cancer were systematically searched.Based on the analysis of the existing symptom cluster intervention studies and symptom intervention guidelines for patients with cancer,effective intervention strategies were extracted,the best evidence for symptom cluster intervention was summarized,and the methods and reasons for intervention were established by combining the biopsychosocial mechanism and perioperative characteristics associated with symptom cluster.Evaluation indexes were selected based on the causative mechanism of symptom cluster and dynamic symptom model,and the draft of perioperative symptom cluster intervention program for patients with NSCLC was sorted out.By conducting qualitative interviews with perioperative patients with NSCLC and their caregivers and holding expert consultation meetings,the intervention draft was revised and improved based on the preferences of patients and caregivers as well as expert opinions.Finally,the clinical version of the perioperative symptom cluster intervention program for patients with NSCLC was formed.2.A non-synchronous controlled quasi-experimental study design was used,and114 patients with NSCLC treated in a tertiary hospital in Anhui Province from April2022 to January 2023 were selected as research objects by convenience sampling method.Patients in the control group received routine department nursing,and patients in the intervention group received symptom cluster intervention program based on routine nursing.On the day of pre-hospitalization before surgery(baseline T0),2 days after surgery(T1),and 1 month after surgery(T2),The general data questionnaire,Chinese Version of M.D.Anderson Symptom Inventory,Lung Cancer Quality of Life Scale,functional status rating scale,the Hospital Anxiety and Depression Scale,perceived Social Support Scale,Self-Efficacy for Managing Chronic Conditions 6-Item Scale,Simplified Coping Style Questionnaire were used to evaluate the subjective outcome indicators of the two groups of patients.Meanwhile,blood samples were collected and the levels of objective outcome indicators IL-1β,IL-2,IL-6,IL-10 and TNF-alpha were determined by ELISA.The overall changes of each outcome index in the two groups were compared at different time points,and the generalized estimation equation was used for analysis.Results1.Results of constructing an intervention program for perioperative symptom clusters in patients with NSCLC1.1 Intervention contents: The intervention contents of preoperative symptom clusters include: fatigue related symptom cluster(fatigue,disturbed sleep),respiratory symptom cluster(cough,phlegm,chest tightness,shortness of breath)and psychological and emotional symptom cluster(distress,sadness).It is necessary to focus on the intervention of fatigue symptoms and psychological and emotional symptoms clusters.The intervention contents of symptom clusters on the second to fourth day after surgery were as follows: Fatigue related symptoms(pain,fatigue,disturbed sleep,drowsiness),respiratory symptoms(cough,phlegm,hemoptysis,chest tightness,shortness of breath),psychological and emotional symptoms(distress,sadness)and digestive symptoms(nausea,vomiting,loss of appetite),need to focus on intervention of fatigue related symptom cluster and respiratory symptom cluster,especially pain and fatigue symptoms.And continued intervention in psychological and emotional symptom cluster;From 2 to 4 days to 1 month after surgery,the intervention contents of symptom clusters were: Fatigue related symptom cluster(pain,fatigue,drowsy),respiratory symptom cluster(cough,phlegm,chest tightness,shortness of breath),psychological and emotional symptom cluster(distress,sadness)and digestive symptom cluster(loss of appetite and weight),need to focus on respiratory symptom cluster,especially chest tightness,shortness of breath,and continue to intervene in psychological and emotional symptom cluster.In the process of actual intervention,individualized assessment based on symptom clusters was carried out to implement targeted intervention.1.2 Intervention methods and reasons: Based on the best evidence of symptom cluster intervention for patients with cancer,effective intervention strategies were extracted according to the biological psychosocial mechanism associated with symptom cluster,combined with key management items in perioperative period,and universal intervention methods were determined,including psychological education intervention,airway management and lung function exercise,dietary nutrition and exercise guidance.Secondly,according to the established intervention contents of symptom clusters,specific intervention methods for fatigue related symptom clusters,respiratory symptom clusters,psychological and emotional symptom clusters and digestive symptom clusters were extracted.On this basis,the content contained in the intervention method was made into 7 manuals for patients,1 manual for interveners,2exercise videos and 10 relaxation audio recordings.During the implementation of intervention,according to the assessment results of symptom clusters and on the basis of universal intervention,personalized intervention was carried out for specific symptom clusters,and intervention auxiliary tool were provided to patients according to the evaluation results.1.3 Intervention personnel,time and place: Clinical nurses,doctors and master’s students were the leading participants.Intervention was conducted on the day of prehospitalization,1 day before surgery,every day after surgery to before discharge,7~10 days after discharge,and 1 month after discharge.Face-to-face guidance was used for in-hospital intervention,and intervention auxiliary tools such as intervention manuals,exercise videos,relaxation audio and respiratory function exercisers were used.The intervention site was selected in the department teaching room or the ward.Outside the hospital,contact was made by telephone or wechat,intervention manual,exercise video,relaxation audio,respiratory function exerciser and other intervention auxiliary tools.1.4 Evaluation indicators: The main outcome indicators were the severity of fatigue related symptom cluster,respiratory symptom cluster,psychological and emotional symptom cluster and digestive symptom cluster,biological indicators(IL-1β,IL-2,IL-6,IL-10 and TNF-α),and psychosocial indicators(psychological distress,social support,self-efficacy and coping style).Secondary outcome measures were quality of life and functional status.2 Results of clinical empirical studies2.1 Patient retention rateA total of 114 NSCLC patients who met the study criteria were recruited,including 58 in the control group and 56 in the intervention group.82 patients were finally completed the whole study,including 42 in the control group and 40 in the intervention group,with a patient retention rate of 71.9%.2.2 Effects of the intervention on the symptom clusters of patients(i)The effect of intervention on fatigue-related symptom clusters.There were group effects,time effects and interaction effects on changes in fatigue-related symptom clusters in the two groups(P<0.001;P<0.001;P<0.01).The results of simple effects analysis showed that after controlling for group,the differences were statistically significant(P<0.001)at all three time points in the control group,with T1 having the highest score,T2 the second highest and T0 the lowest;the differences between T0 and T1,T1 and T2(T1>T0,T1>T2;P<0.001)in the intervention group were statistically significant,while the differences between T0 and T2 were not statistically significant.After the control time point,the control group scored higher than the intervention group in both T1 and T2 periods(P<0.01).(ii)The effect of the intervention on respiratory symptom clusters.There was a group effect and a time effect on respiratory symptom clusters in both groups(P<0.05;P<0.001),and the interaction effect was not statistically significant(P>0.05).Comparison between groups showed that the control group scored higher than the intervention group;two-by-two comparison of different measurement times showed statistically significant differences between T0 and T1(T1>T0),T0 and T2(T2>T0),and no statistically significant differences between T1 and T2.(iii)Effect of intervention on psychological symptom clusters.There was an interaction effect(P<0.001)on psycho-affective symptom clusters in both groups,and the group effect and time effect were not statistically significant.The results of the simple effects analysis showed that after controlling for group,the differences in the control group were not statistically significant at all three time points;the differences between this symptom cluster at T0 and T2(T0>T2,P<0.001)and T1 and T2(T1>T2,P<0.01)in the intervention group were statistically significant,while the differences between T0 and T1 were not statistically significant;after controlling for time point,the control group scored higher in the T2 period was higher than that of the intervention group(P<0.001).(iv)The effect of intervention on digestive symptom clusters.There was a group effect and a time effect(P<0.05;P<0.001)on digestive symptom clusters in both groups,but the interaction effect was not statistically significant(P>0.05),and the comparison between groups showed that the control group scored higher than the intervention group,and the comparison between different measurement times showed that the symptom clusters scored higher in the T1 period than in the T2 period.(v)The results of the Mann-Whitney U test showed that at postoperative day 2,the scores of fatigue,sleep disturbance,drowsiness,chest tightness,nausea,and vomiting were lower in the intervention group than in the control group,with statistically significant differences;at 1 month postoperatively,the scores of fatigue,drowsiness,chest tightness,shortness of breath,distress and sadness were lower in the intervention group than in the control group,and the differences were statistically significant.2.3 Effects of intervention on inflammatory factors of patients(i)The effect of intervention on IL-1β level.There were group effects and time effects on IL-1β levels in both groups(P<0.001;P<0.05),and the interaction effects were not statistically significant(P>0.05).Comparison between groups showed that the control group scored higher than the intervention group;a two-by-two comparison of different measurement times showed a statistically significant difference only between T0 and T1.(ii)The effect of the intervention on IL-2 levels.There were group effects,time effects and interaction effects on IL-2 levels in both groups(P<0.05;P<0.001;P<0.05).The results of simple effect analysis showed that after controlling for group,the differences between T0 and T2(P<0.001)and T1 and T2(P<0.01)were statistically significant in the control group,and the scores were greater in T0 and T1 periods than in T2;the differences between the three time points in the intervention group were not statistically significant;after controlling for time points,the scores were higher in the control group than in the intervention group only in the T1 period between the two groups(P<0.01).(iii)Effect of the intervention on IL-6 levels.There was a time effect and an interaction effect on IL-6 levels in both groups(P<0.001;P<0.01).The results of simple effects analysis showed that after controlling for group,the differences between the three time points in the control group were not statistically significant;the differences between T0 and T1(P<0.001)and T1 and T2(P<0.01)in the intervention group were statistically significant,and the scores in the T0 and T2 periods were greater than T1;after controlling for time points,there was no statistical difference between the two groups at any time point.It can be concluded that IL-6 levels decreased more significantly in the intervention group in the postoperative period.(iv)The effect of the intervention on IL-10 levels.There was a time effect and an interaction effect on IL-10 levels in both groups(P<0.001;P<0.01).The results of simple effects analysis showed that after controlling for group,the differences between all three time points in the control group were not statistically significant;the differences between T0 and T1(P<0.001)and T0 and T2(P<0.05)in the intervention group were statistically significant,with the highest score in the T0 period;after controlling for time point,the IL-10 level in the control group was higher than that in the intervention group at the T1 time point,and the differences were statistically significant(P<0.05).(v)The effect of intervention on TNF-α levels.There was only a time effect on TNF-α levels in both groups(P<0.01).A two-by-two comparison of different measurement times showed statistically significant differences in TNF-α levels between T0 and T1(P<0.01)and T0 and T2(P<0.05),with the highest level in the T0 period.2.4 Effects of the intervention on patients’ quality of life,functional status,psychological distress,social support,self-efficacy and coping styles.(i)The effect of the intervention on quality of life.There were group effects,time effects and interaction effects on quality of life in both groups(P<0.01;P<0.001;P<0.001).The results of the simple effects analysis showed that after controlling for group,the differences in quality of life scores between T0 and T1 and T0 and T2 periods were statistically significant in the control group(P<0.001),with the highest score in T0;the differences between T0 and T1,T1 and T2(T0>T1,T2>T1;P<0.001)were statistically significant in the intervention group,with the lowest quality of life score in T1 period,while T0 and There was no statistically significant difference between T2;after the control time points,the scores of the intervention group were higher than the control group in both T1 and T2 periods(P<0.01).(ii)The effect of intervention on functional status.There was a group effect and a time effect on the level of functional status in both groups(both P<0.001),and the interaction effect was not statistically significant(P>0.05).Comparison between groups showed that the intervention group scored higher than the control group;twoby-two comparison of different measurement times showed statistically significant differences at all three time points(P<0.001),with T0 scoring the highest,T2 the second highest,and T1 the lowest.It can be concluded that the intervention reduced the patients’ improved level of functional status,and there was no statistical difference in the trend of change over time between the two groups.(iii)The effect of the intervention on psychological distress.There was a time effect and an interaction effect on the level of psychological distress in both groups(P<0.001;P<0.01).The results of simple effect analysis showed that after controlling for group,there were statistically significant differences in the level of psychological distress between T0 and T1 and T1 and T2 in the control group(all P<0.05),with the highest score in the T1 period and no statistically significant difference between T0 and T2(P>0.05);there were statistically significant differences between T0 and T2 and T1 and T2 in the intervention group(all P<0.001),with the T2 time period had the lowest score,and the difference between T0 and T1 was not statistically significant(P>0.05).After controlling for time points,the level of psychological distress was higher in the control group than in the intervention group during the T2 period in both groups,with a statistically significant difference(P<0.01).(iv)The effect of the intervention on social support.There was a time effect and an interaction effect on the level of social support in the two groups(P<0.01;P<0.001).The results of simple effects analysis showed that after controlling for group,the differences in social support levels between T0 and T2 and T1 and T2 in the control group were statistically significant(all P<0.001),with the lowest score in the T2 period and no statistically significant difference between T0 and T1(P>0.05);the differences between T0 and T1(P<0.001)and T0 and T2(P<0.01)in the intervention group were statistically significant,with the lowest score in the T0 period and no statistically significant differences between T1 and T2(P>0.05).After controlling for time points,the level of social support was lower in the control group than in the intervention group during the T2 period in both groups,and the difference was statistically significant(P<0.01).(v)The effect of intervention on self-efficacy.There were group effects,time effects and interaction effects on quality of life in both groups(P<0.05;P<0.001;P<0.001).The results of simple effects analysis showed that after controlling for group,the differences in self-efficacy at all three time points in the control group were not statistically significant(P>0.05);the differences between the three time points in the intervention group were statistically significant,with the highest score at T2,followed by T1 and the lowest at T0;after controlling for time points,the scores in the intervention group were higher than those in the control group at both T1 and T2periods(P<0.01).(vi)Effect of intervention on coping style.There was only an interaction effect for positive coping in both groups(P<0.001).The results of the simple effects analysis showed that after controlling for group,the differences in positive coping at all three time points in the control group were not statistically significant(P>0.05);the differences in positive coping between T0 and T1,T0 and T2 in the intervention group were statistically significant(all P<0.001),with the lowest scores in the T0 period;after controlling for time point,the scores in the intervention group were higher than those in the control group in the T2 period(P<0.01).There was no effect of negative coping.ConclusionBased on the perioperative symptom cluster performance of patients with NSCLC explored by the previous study,the current study was based on the best evidence summary,and combined with the biopsychosocial mechanisms associated with symptom clusters,guided by the dynamic symptom model and the individual and family self-management theory,to construct a multimodal symptom cluster intervention program,which was revised and improved by patient and caregiver preferences and expert consultation,and the program was effective in reducing patients’ perioperative fatigue-related,respiratory,psycho-affective,and digestive symptom clusters,reducing IL-1β,IL-2 and IL-10 levels,improving quality of life and functional status,reducing psychological distress,increasing social support,selfefficacy,and promoting positive coping. |
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