| BackgroundBreast cancer is one of the most common malignant tumors in women and a common cause that seriously threatens women’s health.Its diagnosis and treatment have brought a series of negative emotions such as anxiety and depression to patients.With the development of positive psychology,it has been found that while breast cancer patients have negative feelings,some individuals can still adapt well.Resilience plays a crucial role in patients’ adaptation to the disease.In recent decades,researches on resilience mainly focus on exploring its influencing factors and mechanism,etc.On this basis,researchers have begun to pay attention to the interventional research.Well-designed intervention study can be used as the best evidence-based nursing research.And the current intervention studies about resilience in breast cancer patients is still in its infancy,intervention methods are lack of rigorous scientific design,intervention plan formation process is not clear,so it is necessary to follow the steps of nursing intervention plan and develop a study protocol.ObjectiveAn evidence-based intervention program for resilience of breast cancer patients based on protective factors suitable for China’s cultural background is preliminarily developed to provide scientific methods for guiding patients to actively cope with diseases and further improving their psychological and social rehabilitation.Methods1.Literature analysis: The literatures on resilience intervention in cancer patients were reviewed systematically and literature analyzed.On the basis of literature review,the study protocol was developed by combining with the results of our previous work.2.Structured interview: Breast cancer patients and nurses from four tertiary class A hospitals in Anhui province were selected to interview.According to the opinions of patients and nurses,the study protocol was preliminarily revised.3.Expert meeting: A panel meeting including breast cancer clinical treatment experts,breast cancer clinical nursing experts,nursing experts,psychological experts,behavioral experts was organized.According to experts’ opinions,the study protocol was further revised.4.Pilot study: A randomized controlled trial was carried out.Breast cancer patients from the department of breast surgery in anhui province were recruited and randomly divided into the intervention group and the control group.The control group was given routine nursing care,and the intervention group was given resilience intervention on the basis of routine nursing care.A survey concerning patients of two groups were conducted by 14 items Resilience Scale,General self-efficacy Scale,Multidimensional Scale of Perceived Social Support,Revised Life Orientation Test and Self-Mastery Scale for Chinese version in the pre-intervention,mid-intervention and post-intervention.Two independent sample t-test and Repeated Measurement ANOVA were used to evaluate intervention effects.Recruitment rate,completion rate,patients satisfaction and intervention compliance were used to evaluate the feasibility of the protocol.According to the results of pilot study,the study protocol was revised and preliminary constructed.Results1.Literature analysis: Most of the intervention subjects in the 20 interventional studies were breast cancer patients,and the intervention was carried out by nurses,researchers,intervention groups or professionals.The frequency of intervention ranged from 1 to 3 times per week or 1 time per chemotherapy course for 3 weeks to 1 year,ranging from 4 to 11 times in total,with each intervention lasting from 30 to 180 minutes.Intervention methods included individual intervention and group intervention.A preliminary intervention draft framework was formed: one-to-one and face-to-face individualized intervention was adopted;The intervention targets were breast cancer patients who were about to undergo surgery after the first diagnosis.The frequency of intervention was 4 times,and the duration of each intervention was 20~30min.The time points of intervention were 1 day before surgery,3 days after surgery,the first postoperative chemotherapy period,and the second postoperative chemotherapy period.Class Ⅱ experimental design was adopted,and the patients were grouped according to the time of hospitalization.The control group received routine nursing,and the intervention group received resilience intervention on this basis.The subjects of the 4interventions were perceived social support,optimism,mastery and self-efficacy.The outcomes were evaluated before,after and follow-up the intervention(during the third postoperative chemotherapy hospitalization).2.Structured interview: 30 breast cancer patients and 27 nurses were interviewed.They all affirmed the individualized forms of one-to-one and face-to-face intervention.According to their opinions,the protocol was revised as follows: the duration of intervention was revised as "each time duration depends on the individual situation of different patients and the completion of the expected goal".The time of the second intervention was revised as "the second to fourth day after surgery,depending on the postoperative recovery status of different patients",the time of the fourth interventionwas revised as "the third postoperative chemotherapy period",and the follow-up time was changed to "the fourth postoperative chemotherapy period".In terms of intervention contents,patients and nurses did not put forward specific revision opinions due to the lack of professional knowledge of psychology and behavior.3.Expert meeting: A total of 10 experts participated in this expert meeting,with the expert authority coefficient of 0.8125.According to experts’ opinions,the study design of the study protocol was revised to a randomized controlled trial.The intervention time points were revised as "2 days after diagnosis","1 day before postoperative discharge","before the first postoperative chemotherapy","before the second postoperative chemotherapy","before the third postoperative chemotherapy","before the fourth postoperative chemotherapy" and "after the last postoperative chemotherapy".The duration of each intervention was revised as "depending on the individual condition of the patient and the completion of the expected goal,about 30 to40 minutes each time".The intervention content was revised to focus on self-efficacy.According to Self-Efficacy Theory,the content was designed from four information sources including performance accomplishments,vicarious learning,verbal encouragement,and others(combined with perceived social support,optimism and mastery).4.Pilot study: 20 breast cancer patients were recruited in the intervention group and the control group respectively.There was no statistically significant difference in the general information and the scores of the scales before intervention between the two groups(P>0.05).Results of both PP analysis and ITT analysis showed that the total scores of resilience in the two groups were statistically significant(P<0.05).Repeated Measurement ANOVA was used to evaluate intervention effect,Only PP analysis results show that the main effect of intervention on resilience statistically significant(P<0.05).The feasibility evaluation results showed that the recruitment rate,completion rate,patients satisfaction and high,medium and low intervention compliance were 90.9%,70.0%,100%,35.7%,28.6% and 35.7%.According to the process of piolt study,the study protocol was revised as follows: the time of the first intervention was revised as "after diagnosis";The intervention frequency was revised as 6 interventions.The homework was revised as by WeChat.ConclusionBased on evidence,theory and methodology,the study protocol of resilience in breast cancer patients was preliminarily developed.The process of study protocol development is systematic and scientific,and the study protocol is targeted,practical and feasibility,which provides a scientific and effective method for clinical nursing staff to carry out clinical psychological intervention. |
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