中医综合治疗提高结直肠癌术后根治率的队列研究监查与定性研究
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摘要
本课题来源于国家“十一五”科技支撑计划国际合作项目课题——中医综合治疗方案提高结直肠癌术后根治率的国际多中心示范研究,国内8家中心共入组病例319例,形成中西医结合与西医2个对列,国外为挪威西医队列共160例,监查中发现,除中西医结合队列为西医常规治疗(根据NCCN临床指引,根治术后,加或不加化疗、放疗)加中医综合治疗(辨证论治汤药加或不加中成药)外,西医队列里的部分患者在西医常规治疗的同时,也会到中医院进行中医药治疗。这些患者寻求中医治疗的目的为何,单纯的定量研究很难回答。本课题中之所以设计了定性研究,旨在了解结直肠癌术后患者寻求中医综合治疗的目的,对中医药治疗的态度和期望,以及中医治疗的体验、信念和可能存在的问题与障碍,了解上述因素可能与治疗结局之间的关系。
本文主要由三大部分组成,第一部分是国家“十一五”科技支撑计划国际合作项目课题——“中医综合治疗方案提高结直肠癌术后根治率的国际多中心示范研究”国内部分的监查具体实施过程和结果,由监查发现的问题引出定性研究。第二部分为定性研究,包括2个研究课题,前者为定量问卷调查,后者是个人深入访谈,2个研究目的一致,具有一定的连贯性且逐渐深入,前者是后者的基础,后者是前者的补充。第三部分为2篇综述,综述一介绍了定性研究的概念、特点、理论基础、主要方法,在循证中医药学中的作用地位,以及在中医药临床研究中的应用概况和启示等。综述二主要介绍了国内外定性研究在肿瘤研究领域应用概况和进展。下面分别介绍3个研究课题。第一部分、中医综合治疗方案提高结直肠癌术后根治率的前瞻性队列研究监查
背景：“中医综合治疗方案提高结直肠癌术后根治率的前瞻性队列研究”是国家“十一五”科技支撑计划国际合作项目课题——中医综合治疗方案提高结直肠癌术后根治率的国际多中心示范研究的重要内容,目的是为印证在西医常规治疗基础上加用中医综合治疗方案减少Ⅱ、Ⅲ期结直肠癌复发、转移,提高根治率这一疗效,形成临床可行的Ⅱ、Ⅲ期结直肠癌根治术后综合治疗方案并加以推广。本研究采用前瞻队列研究方法,国内分中西医结合与西医2个对列,共8家中心参与,随访时间长,对象易发生队列迁移,也容易失访,所以临床监查是质量控制的重点和难点。
目的：对中医综合治疗方案提高结直肠癌术后根治率的前瞻性队列研究国内多中心进行监查,及时发现课题进程中存在的问题并加以纠正,从而促进课题进度并提高研究质量。
方法：对国内各研究中心进行定期访视,重点监查病例入组和病例报告表的填写情况,每次访视后均要撰写监查报告,每3个月起草一份研究进度与质量监查报告,向课题负责人汇报。
结果：国内病例已完成入组,随访最长已36个月,最短为13个月,研究者协助课题负责人召开了四次中期会。监查发现,课题入组进行得过于缓慢,影响入组进度的主要原因是患者的依从性不高,中医医院的患者中有的没按推荐的中医治疗方案坚持中医治疗达到要求时间,而西医医院中有少数病人也在进行中医治疗,除西苑医院外,其它中心的病人日记多未填写,由于研究人员工作繁忙,部分患者未严格按照课题的要求进行复查,CRF表不能及时填写。
结论：队列研究的监查与RCT临床试验的监查不尽相同,目前在中医药前瞻性队列研究监查方面,尚没有成熟的经验可以借鉴,研究者在国家十一五课题中进行了尝试和探索。患者的依从性是影响入组进度的主要原因之一,患者对自己信任的专家的依从性高于下级普通大夫,按时随访、减少失访是入组完成后的重要工作,有效的协调和沟通有利于多中心研究的各组间资料的平衡,及时地详细记录患者的诊疗过程是提高研究质量的主要措施。定期监查保证了课题的进度和质量,形成了有效的协调和沟通机制。由于每次患者入组、随访和填表都要耗费较长的时间,研究者要在规定的时间内完成研究任务,需要投入大量的时间和精力。监查中还发现西医队列里的部分患者在西医常规治疗的同时,也会到中医院进行中医药治疗,这些患者寻求中医治疗的目的为何,单纯的定量研究很难回答,需要引入定性研究。第二部分、结直肠癌患者术后寻求中医治疗的定性研究
背景：目前,结直肠癌患者中寻求中医治疗者越来越多,就连西医医院的患者也在或多或少地进行中医药治疗,不仅是晚期的患者,许多早中期的患者在接受西医常规治疗的同时也进行中医综合治疗,特别是在西医常规治疗均完成后,部分患者仍坚持长期的中医综合治疗,但目前尚没有系统的研究资料显示结直肠癌患者手术后寻求中医综合治疗的具体动机和态度如何。
研究一、结直肠癌患者术后寻求中医治疗的问卷调查
目的：了解结直肠癌术后患者寻求中医综合治疗的目的,对中医药治疗的态度和认识,总结患者较为关心的问题,为下一步进行个人深入访谈做准备。
方法：选取2009年3月1日至2009年6月30日期间来西苑医院肿瘤科门诊就诊的结直肠癌根治术后病理分期为Ⅱ、Ⅲ期的患者,在复诊时口头征得患者的同意后发给自拟的结构式调查问卷,使用SPSS软件进行统计分析。
结果：在128符合条件的Ⅱ、Ⅲ期结直肠癌患者中,男67例,女61例,口头同意接受调查者共120人,参与率为93.75%。发放调查表120份,收回115份,问卷回收率为95.83%,有8份问卷被判定为不合格问卷而被剔除,最终107份有效问卷纳入统计。在107位患者中,有49位患者既往看过中医,仅3位患者认为效果不好。在手术以后,有70%的患者选择了在术后一年内开始中医药治疗；对于选择中医治疗的目的,有51.40%(55/107)的患者选择了抗复发转移,有27.10%(29/107)的患者选择了减轻放、化疗副作用;经等级相关分析,寻求中医治疗的目的与开始中医治疗距手术的时间具有一定的相关性(P<0.05)。经过一段时间的中医治疗后,约90%的受访者对治疗表示满意；在影响中医治疗的因素方面,有59.81%(64/107)的受访者认为是疗效,只有17.76%(19/107)和14.95%(16/107)的患者分别选择了中药不好喝和挂号难,经Logistic回归多因素分析,性别、年龄、职业、教育程度均未显示与中医药治疗满意度呈一定的相关性(P>0.05)。
结论：患者寻求中医药治疗的原因除了受既往中医治疗有效的影响外,还有其它的原因存在。患者看中医的目的随术后时间不同而变化,术后一年内多是为了减轻放、化疗副作用,术后一年以后开始中医综合治疗的较多的目的是防复发转移。绝大多数患者对中医的评价都比较客观,对近期中医药治疗的疗效都表示满意,对远期的抗复发转移充满信心。
研究二、结直肠癌患者术后寻求中医综合治疗的定性访谈
目的：在问卷调查的基础上,采用个人深入访谈的方法,深入了解结直肠癌术后患者寻求中医综合治疗的目的,对中医药治疗的认识、态度和期望,以及中医治疗的体验、信念和可能存在的问题与障碍,了解上述因素可能与治疗结局之间的关系。
方法：采取目的抽样的办法,选取18位结直肠癌术后患者,根据事先拟定的访谈提纲进行个人深入访谈,将录音资料转录为文字稿,反复阅读文字稿,进行标引和编码,经归纳产生主题和副主题,并使用ATLAS. ti定性分析软件进行辅助分析。
结果：大部分患者术后接受了西医常规治疗,有的是在西医治疗的同时就开始中医治疗,有的是在完成了西医常规治疗之后才开始来看中医。在患者眼中,中医和西医并不是互相排斥的,而是各有所长,互相补充的,也有一部分患者开始对中医药持有异议,但是中医的疗效让他们改变了对中医药的认识和看法,从而变成了中医药的拥护者和宣传者。对于结直肠癌术后的患者,选择中医药治疗的目的主要有以下几个方面：减轻放、化疗的毒副作用(不良反应),使身体尽快恢复,提高生活质量,防止复发转移,有的患者是因为吃中药使生活彻底改变了,从此中药也变成了生活的一部分,并从中感悟出了一定的道理。
结论：患者选择中医的途径虽有不同,但都目标明确,对中医治疗充满期望,同时对中医的认识也在随着治疗的延续而逐渐改变,患者寻求中医治疗的最终目的是防复发转移,就医过程中的困难和障碍并未影响患者坚持中医治疗的信心。中医的疗效不仅体现在症状的改善上,还体现在客观指标的改善上,近期良好的治疗体验使患者对实现远期目标更具信心。
本研究是国家十一五科技支撑计划国际合作项目课题的一部分,整个课题仍在进行当中,后续研究者将继续对入组患者进行随访,观察中医综合治疗对结直肠癌术后复发转移率的影响。该课题的最终目的是客观评价中医综合治疗的疗效,确立中医综合治疗方案,评价此方案减低Ⅱ、Ⅲ期结直肠癌复发、转移及提高根治率的干预作用,并将定性研究与前瞻性队列研究相结合,使定量与定性研究互相补充,为中医药医疗实践提供更广泛、深入的知识和证据,从而能让更多的结直肠癌患者能从中医药治疗中获益。但是,中医药治疗需要坚持多长时间为宜,尚没有定论,有待于进一步研究。
This study comes from the national "11th Five-Year plan international cooperation projects supporting science and technology issues-an international multi-center study model of integrated traditional Chinese medicine treatment to improve the cure rate of colorectal cancer, including the international multi-center prospective cohort study and qualitative research. It is to be understood that why the colorectal cancer patients seek for traditional Chinese medicine (TCM) after operation, and their experiences, beliefs, and possible problems and obstacles, in order to find the relationship between these factors and the treatment outcome. An important part of the subject is an international multi-center prospective cohort study,310 patients from eight national centers and 160 cases from Norway are enrolled. I served as a monitor of the domestic part of this study.
This paper is combined with three parts. The first part is the audit process and the specific implementation results of the domestic part of the cohort research. The second part consists of two research topics, which have the same purpose, and the latter complement the former. The third part includes two reviews. A review of qualitative studies described the concept, characteristics, theoretical foundation, the main method of Chinese medicine in the role of evidence-based status, as well as in clinical research in the application profiles and enlightenment. The other one introduces the qualitative research applications in domestic and international cancer research. Part I Monitoring in Multicenter Prospective Cohort Study on TCM Therapy to Improve Cure Rates of Colorectal after Operation
Objective:Monitor to multicenter prospective cohort study to discover the problems in the process and corrected them, so as to promote progress and improve the quality of the research.
Methods:Visited the research centers on the domestic regular, Audit focused on the enrolled case and the case report forms. Prepare a study schedule and quality reports to the project leader every 3 months.
Conclusions:Patients compliance was the main reason affecting the enroll progress. The next important work was follow-up in time, in order not to lose. Periodic monitor could ensure the progress and quality of the study.
Part II Qualitative Research of Colorectal Cancer Patients Seeking For TCM after Operation
Background:Currently, more and more colorectal cancer patients seek for treatment with TCM even those in early and middle stage while they are treated whit western medicine. Especially after the radical surgery and adjuvant chemotherapy and radiotherapy, these western medicine treatments are completed, some patients still insist on long-term treatment with TCM. But no systematic research data is about their specific motive and attitude.
StudyⅠA Questionnaire Survey of Colorectal Cancer Patients Seeking For TCM after Operation
Objective:To understand purpose of patients with colorectal cancer seeking for TCM after operation, and their attitude and understanding about TCM, prepare for the personal in-depth interviews.
Methods:Select the colorectal cancer patients in stageⅡorⅢfrom March 1,2009 to June 30,2009 in Xiyuan Hospital, referral consent to be issued from the structured questionnaire, statistic analysis with the SPSS software.
Results:In the 128 colorectal cancer patients in stageⅡorⅢ, male 67, female 61,120 patients were surveyed, the participation rate was 93.75%.115 were recovered, the rate was 95.83%,8 questionnaires were deemed to be excluded,107 valid questionnaires were included in the final statistics. In 107 patients,49 ones had taken TCM, only three patients apply that it is not effective. After surgery,70% of patients began the TCM treatment within one year, About 51.40% of patients whose purpose were anti-recurrence and metastasis, and 27.10% of patients wanted to reduce the side effects of radiotherapy or chemotherapy. After a period of the treatment, about 90% of the respondents expressed satisfaction with TCM. 59.81% of respondents considered the effect as the main factor which affected them insisting in TCM.
Conclusions:There were some reasons for the patients seeking for TCM, except for the past effective treatment. The purpose of the patients varied with time. Most of them wanted to reduce the side effects of radiotherapy and chemotherapy within lyear after operation. But the others who took TCM a year later wanted to prevent recurrence and metastasis. Most patients evaluated objectively on TCM, they expressed satisfaction with term effect and confidenced on anti-recurrence and metastasis.
StudyⅡA Qualitative Interview about Colorectal Cancer Patients Seeking For TCM after Radical Resection
Objective:Based on the questionnaire survey, this study was designed in individual in-depth interview, to understood that why the colorectal cancer patients seek for TCM after operation, and their experiences, beliefs, and possible problems and obstacles, in order to find the relationship between these factors and the treatment outcome.
Methods:Using purposeful sampling,18 colorectal cancer patients were interviewed. Transcribed the recording information to the scripts, and analyzed with software named ATLAS, ti.
Results:Most patients received standard treatment in the general hospital or specialty hospital, some of them began the treatment of TCM and the western medicine at the same time, and others began the treatment of TCM after the western medicine. In the eyes of patients, Chinese medicine and Western medicine were not mutually exclusive, but complementary. The main purposes for TCM were as following aspects:to reduce the side effects of chemotherapy, improve the quality of life and reduce the recurrence and metastasis.
Conclusions:Although the patients choose TCM in different ways, but they were full of expectations. At the same time their understanding were changing with continuation of the treatment. The ultimate goal of the Patients seeking for TCM was to prevent recurrence and metastasis. The difficulties and obstacles during the treatment did not affect their confidence of TCM. The efficacies of TCM were embodied not only in the improvement of symptomatic, but also in the improvement of objective indicators. Recent experience gave the patients more confidence to the long-term goal.
本文主要由三大部分组成,第一部分是国家“十一五”科技支撑计划国际合作项目课题——“中医综合治疗方案提高结直肠癌术后根治率的国际多中心示范研究”国内部分的监查具体实施过程和结果,由监查发现的问题引出定性研究。第二部分为定性研究,包括2个研究课题,前者为定量问卷调查,后者是个人深入访谈,2个研究目的一致,具有一定的连贯性且逐渐深入,前者是后者的基础,后者是前者的补充。第三部分为2篇综述,综述一介绍了定性研究的概念、特点、理论基础、主要方法,在循证中医药学中的作用地位,以及在中医药临床研究中的应用概况和启示等。综述二主要介绍了国内外定性研究在肿瘤研究领域应用概况和进展。下面分别介绍3个研究课题。第一部分、中医综合治疗方案提高结直肠癌术后根治率的前瞻性队列研究监查
背景：“中医综合治疗方案提高结直肠癌术后根治率的前瞻性队列研究”是国家“十一五”科技支撑计划国际合作项目课题——中医综合治疗方案提高结直肠癌术后根治率的国际多中心示范研究的重要内容,目的是为印证在西医常规治疗基础上加用中医综合治疗方案减少Ⅱ、Ⅲ期结直肠癌复发、转移,提高根治率这一疗效,形成临床可行的Ⅱ、Ⅲ期结直肠癌根治术后综合治疗方案并加以推广。本研究采用前瞻队列研究方法,国内分中西医结合与西医2个对列,共8家中心参与,随访时间长,对象易发生队列迁移,也容易失访,所以临床监查是质量控制的重点和难点。
目的：对中医综合治疗方案提高结直肠癌术后根治率的前瞻性队列研究国内多中心进行监查,及时发现课题进程中存在的问题并加以纠正,从而促进课题进度并提高研究质量。
方法：对国内各研究中心进行定期访视,重点监查病例入组和病例报告表的填写情况,每次访视后均要撰写监查报告,每3个月起草一份研究进度与质量监查报告,向课题负责人汇报。
结果：国内病例已完成入组,随访最长已36个月,最短为13个月,研究者协助课题负责人召开了四次中期会。监查发现,课题入组进行得过于缓慢,影响入组进度的主要原因是患者的依从性不高,中医医院的患者中有的没按推荐的中医治疗方案坚持中医治疗达到要求时间,而西医医院中有少数病人也在进行中医治疗,除西苑医院外,其它中心的病人日记多未填写,由于研究人员工作繁忙,部分患者未严格按照课题的要求进行复查,CRF表不能及时填写。
结论：队列研究的监查与RCT临床试验的监查不尽相同,目前在中医药前瞻性队列研究监查方面,尚没有成熟的经验可以借鉴,研究者在国家十一五课题中进行了尝试和探索。患者的依从性是影响入组进度的主要原因之一,患者对自己信任的专家的依从性高于下级普通大夫,按时随访、减少失访是入组完成后的重要工作,有效的协调和沟通有利于多中心研究的各组间资料的平衡,及时地详细记录患者的诊疗过程是提高研究质量的主要措施。定期监查保证了课题的进度和质量,形成了有效的协调和沟通机制。由于每次患者入组、随访和填表都要耗费较长的时间,研究者要在规定的时间内完成研究任务,需要投入大量的时间和精力。监查中还发现西医队列里的部分患者在西医常规治疗的同时,也会到中医院进行中医药治疗,这些患者寻求中医治疗的目的为何,单纯的定量研究很难回答,需要引入定性研究。第二部分、结直肠癌患者术后寻求中医治疗的定性研究
背景：目前,结直肠癌患者中寻求中医治疗者越来越多,就连西医医院的患者也在或多或少地进行中医药治疗,不仅是晚期的患者,许多早中期的患者在接受西医常规治疗的同时也进行中医综合治疗,特别是在西医常规治疗均完成后,部分患者仍坚持长期的中医综合治疗,但目前尚没有系统的研究资料显示结直肠癌患者手术后寻求中医综合治疗的具体动机和态度如何。
研究一、结直肠癌患者术后寻求中医治疗的问卷调查
目的：了解结直肠癌术后患者寻求中医综合治疗的目的,对中医药治疗的态度和认识,总结患者较为关心的问题,为下一步进行个人深入访谈做准备。
方法：选取2009年3月1日至2009年6月30日期间来西苑医院肿瘤科门诊就诊的结直肠癌根治术后病理分期为Ⅱ、Ⅲ期的患者,在复诊时口头征得患者的同意后发给自拟的结构式调查问卷,使用SPSS软件进行统计分析。
结果：在128符合条件的Ⅱ、Ⅲ期结直肠癌患者中,男67例,女61例,口头同意接受调查者共120人,参与率为93.75%。发放调查表120份,收回115份,问卷回收率为95.83%,有8份问卷被判定为不合格问卷而被剔除,最终107份有效问卷纳入统计。在107位患者中,有49位患者既往看过中医,仅3位患者认为效果不好。在手术以后,有70%的患者选择了在术后一年内开始中医药治疗；对于选择中医治疗的目的,有51.40%(55/107)的患者选择了抗复发转移,有27.10%(29/107)的患者选择了减轻放、化疗副作用;经等级相关分析,寻求中医治疗的目的与开始中医治疗距手术的时间具有一定的相关性(P<0.05)。经过一段时间的中医治疗后,约90%的受访者对治疗表示满意；在影响中医治疗的因素方面,有59.81%(64/107)的受访者认为是疗效,只有17.76%(19/107)和14.95%(16/107)的患者分别选择了中药不好喝和挂号难,经Logistic回归多因素分析,性别、年龄、职业、教育程度均未显示与中医药治疗满意度呈一定的相关性(P>0.05)。
结论：患者寻求中医药治疗的原因除了受既往中医治疗有效的影响外,还有其它的原因存在。患者看中医的目的随术后时间不同而变化,术后一年内多是为了减轻放、化疗副作用,术后一年以后开始中医综合治疗的较多的目的是防复发转移。绝大多数患者对中医的评价都比较客观,对近期中医药治疗的疗效都表示满意,对远期的抗复发转移充满信心。
研究二、结直肠癌患者术后寻求中医综合治疗的定性访谈
目的：在问卷调查的基础上,采用个人深入访谈的方法,深入了解结直肠癌术后患者寻求中医综合治疗的目的,对中医药治疗的认识、态度和期望,以及中医治疗的体验、信念和可能存在的问题与障碍,了解上述因素可能与治疗结局之间的关系。
方法：采取目的抽样的办法,选取18位结直肠癌术后患者,根据事先拟定的访谈提纲进行个人深入访谈,将录音资料转录为文字稿,反复阅读文字稿,进行标引和编码,经归纳产生主题和副主题,并使用ATLAS. ti定性分析软件进行辅助分析。
结果：大部分患者术后接受了西医常规治疗,有的是在西医治疗的同时就开始中医治疗,有的是在完成了西医常规治疗之后才开始来看中医。在患者眼中,中医和西医并不是互相排斥的,而是各有所长,互相补充的,也有一部分患者开始对中医药持有异议,但是中医的疗效让他们改变了对中医药的认识和看法,从而变成了中医药的拥护者和宣传者。对于结直肠癌术后的患者,选择中医药治疗的目的主要有以下几个方面：减轻放、化疗的毒副作用(不良反应),使身体尽快恢复,提高生活质量,防止复发转移,有的患者是因为吃中药使生活彻底改变了,从此中药也变成了生活的一部分,并从中感悟出了一定的道理。
结论：患者选择中医的途径虽有不同,但都目标明确,对中医治疗充满期望,同时对中医的认识也在随着治疗的延续而逐渐改变,患者寻求中医治疗的最终目的是防复发转移,就医过程中的困难和障碍并未影响患者坚持中医治疗的信心。中医的疗效不仅体现在症状的改善上,还体现在客观指标的改善上,近期良好的治疗体验使患者对实现远期目标更具信心。
本研究是国家十一五科技支撑计划国际合作项目课题的一部分,整个课题仍在进行当中,后续研究者将继续对入组患者进行随访,观察中医综合治疗对结直肠癌术后复发转移率的影响。该课题的最终目的是客观评价中医综合治疗的疗效,确立中医综合治疗方案,评价此方案减低Ⅱ、Ⅲ期结直肠癌复发、转移及提高根治率的干预作用,并将定性研究与前瞻性队列研究相结合,使定量与定性研究互相补充,为中医药医疗实践提供更广泛、深入的知识和证据,从而能让更多的结直肠癌患者能从中医药治疗中获益。但是,中医药治疗需要坚持多长时间为宜,尚没有定论,有待于进一步研究。
This study comes from the national "11th Five-Year plan international cooperation projects supporting science and technology issues-an international multi-center study model of integrated traditional Chinese medicine treatment to improve the cure rate of colorectal cancer, including the international multi-center prospective cohort study and qualitative research. It is to be understood that why the colorectal cancer patients seek for traditional Chinese medicine (TCM) after operation, and their experiences, beliefs, and possible problems and obstacles, in order to find the relationship between these factors and the treatment outcome. An important part of the subject is an international multi-center prospective cohort study,310 patients from eight national centers and 160 cases from Norway are enrolled. I served as a monitor of the domestic part of this study.
This paper is combined with three parts. The first part is the audit process and the specific implementation results of the domestic part of the cohort research. The second part consists of two research topics, which have the same purpose, and the latter complement the former. The third part includes two reviews. A review of qualitative studies described the concept, characteristics, theoretical foundation, the main method of Chinese medicine in the role of evidence-based status, as well as in clinical research in the application profiles and enlightenment. The other one introduces the qualitative research applications in domestic and international cancer research. Part I Monitoring in Multicenter Prospective Cohort Study on TCM Therapy to Improve Cure Rates of Colorectal after Operation
Objective:Monitor to multicenter prospective cohort study to discover the problems in the process and corrected them, so as to promote progress and improve the quality of the research.
Methods:Visited the research centers on the domestic regular, Audit focused on the enrolled case and the case report forms. Prepare a study schedule and quality reports to the project leader every 3 months.
Conclusions:Patients compliance was the main reason affecting the enroll progress. The next important work was follow-up in time, in order not to lose. Periodic monitor could ensure the progress and quality of the study.
Part II Qualitative Research of Colorectal Cancer Patients Seeking For TCM after Operation
Background:Currently, more and more colorectal cancer patients seek for treatment with TCM even those in early and middle stage while they are treated whit western medicine. Especially after the radical surgery and adjuvant chemotherapy and radiotherapy, these western medicine treatments are completed, some patients still insist on long-term treatment with TCM. But no systematic research data is about their specific motive and attitude.
StudyⅠA Questionnaire Survey of Colorectal Cancer Patients Seeking For TCM after Operation
Objective:To understand purpose of patients with colorectal cancer seeking for TCM after operation, and their attitude and understanding about TCM, prepare for the personal in-depth interviews.
Methods:Select the colorectal cancer patients in stageⅡorⅢfrom March 1,2009 to June 30,2009 in Xiyuan Hospital, referral consent to be issued from the structured questionnaire, statistic analysis with the SPSS software.
Results:In the 128 colorectal cancer patients in stageⅡorⅢ, male 67, female 61,120 patients were surveyed, the participation rate was 93.75%.115 were recovered, the rate was 95.83%,8 questionnaires were deemed to be excluded,107 valid questionnaires were included in the final statistics. In 107 patients,49 ones had taken TCM, only three patients apply that it is not effective. After surgery,70% of patients began the TCM treatment within one year, About 51.40% of patients whose purpose were anti-recurrence and metastasis, and 27.10% of patients wanted to reduce the side effects of radiotherapy or chemotherapy. After a period of the treatment, about 90% of the respondents expressed satisfaction with TCM. 59.81% of respondents considered the effect as the main factor which affected them insisting in TCM.
Conclusions:There were some reasons for the patients seeking for TCM, except for the past effective treatment. The purpose of the patients varied with time. Most of them wanted to reduce the side effects of radiotherapy and chemotherapy within lyear after operation. But the others who took TCM a year later wanted to prevent recurrence and metastasis. Most patients evaluated objectively on TCM, they expressed satisfaction with term effect and confidenced on anti-recurrence and metastasis.
StudyⅡA Qualitative Interview about Colorectal Cancer Patients Seeking For TCM after Radical Resection
Objective:Based on the questionnaire survey, this study was designed in individual in-depth interview, to understood that why the colorectal cancer patients seek for TCM after operation, and their experiences, beliefs, and possible problems and obstacles, in order to find the relationship between these factors and the treatment outcome.
Methods:Using purposeful sampling,18 colorectal cancer patients were interviewed. Transcribed the recording information to the scripts, and analyzed with software named ATLAS, ti.
Results:Most patients received standard treatment in the general hospital or specialty hospital, some of them began the treatment of TCM and the western medicine at the same time, and others began the treatment of TCM after the western medicine. In the eyes of patients, Chinese medicine and Western medicine were not mutually exclusive, but complementary. The main purposes for TCM were as following aspects:to reduce the side effects of chemotherapy, improve the quality of life and reduce the recurrence and metastasis.
Conclusions:Although the patients choose TCM in different ways, but they were full of expectations. At the same time their understanding were changing with continuation of the treatment. The ultimate goal of the Patients seeking for TCM was to prevent recurrence and metastasis. The difficulties and obstacles during the treatment did not affect their confidence of TCM. The efficacies of TCM were embodied not only in the improvement of symptomatic, but also in the improvement of objective indicators. Recent experience gave the patients more confidence to the long-term goal.
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[5]Goel V, Gray R, Chart P, et al. Perspectives on colorectal cancer screening:a focus group study. Health Expect,2004,7(1):51-60
[6]Carney L, Jones L, Braddon F, et al.A colorectal cancer patient focus group develops an information package. Ann R Coll Surg Engl, 2006,88 (5):447-449
[7]Agincourt-Canning L. The effect of experiential knowledge on construction of risk perception in hereditary breast/ovarian cancer. J Genet Couns,2005,14(1):55-69
[8]Friedman DB, Hoffman-Goetz L. Sources of cancer information for seniors:a focus group pilot study report. J Cancer Educ,2003,8(4):15-22
[9]Wallace M, Storms S. The needs of men with prostate cancer:results of a focus group study. Appl Nurs Res,2007,20(4):181-187
[10]Reynolds MA. Hope in adults, ages 20-59, with advanced stage cancer. Palliat Support Care,2008,6(3):259-64
[11]Chapple A, Ziebland S, McPherson A. Stigma, shame, and blame experienced by patients with lung cancer:qualitative study. BMJ, 2004,328 (7454):1470
[12]Villafuerte BE, Gomez LL, Betancourt AM, et al. Cervical cancer:a qualitative study on subjectivity, family, gender and health services. Reprod Health,2007,4(5):2
[13]Anvik T, Holtedahl KA, Mikalsen H. "When patients have cancer, they stop seeing me"-the role of the general practitioner in early follow-up of patients with cancer-a qualitative study. BMC Fam Pract,2006,21(7):19
[14]Chapple A, Ziebland S, McPherson A, et al. Lung cancer patients' perceptions of access to financial benefits:a qualitative study. Br J Gen Pract,2004,54(5):589-594
[15]Liu JE, Mok E, Wong T. Caring in nursing:investigating the meaning of caring from the perspective of cancer patients in Beijing, China. J Clin Nurs,2006,15(2):188-196
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[20]Watanabe Y, Takahashi M, Kai I. Japanese cancer patient participation in and satisfaction with treatment-related decision-making:A qualitative study. BMC Public Health,2008,27(8):77
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[22]Odedina FT, Scrivens J, Emanuel A, et al. A focus group study of factors influencing African-American men's prostate cancer screening behavior. J Natl Med Assoc,2004,96(6):780-788
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[1]刘建平.循证中医药定性研究方法学.北京：人民卫生出版社,2009：1-2
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[17]杨闵,刘建平.Campbell协作网——的社会、心理和教育决策与实践.医学与哲学,2002,23(2)：43-44
[18]刘建平.循证中医药临床研究方法学.北京：人民卫生出版社,2006：173-176
[19]韩亚男,傅东波.试论中医临床科研中引入定性研究的必要性.中西医结合学报,2004,2(5)：330-332
[20]谢雁鸣,廖星.定性研究的主要方法及其在中医临床研究中切入点的探讨.中医杂志,2008,49(6)：550-553
[21]刘建平.定性研究与循证医学.中国中西医结合杂志,2008,28(2)：165-167
[22]刘建平.中医药临床试验的方法学问题与挑战：循证医学观点.中西医结合学报,2006,4(1)：1-6
[23]于河,刘建平.定性研究方法及其在医学领域内的应用.循证医学,2008,8(5)：292-295
[24]谢雁鸣,廖星.定性研究现状分析.北京中医药大学学报,2008,31(4)：232-234
[25]费宇彤.定性研究在针灸临床研究中的应用.中国中西医结合杂志,2008,28(2)：171-173
[26]Britten N, Green J. Qualitative research and evidence based medicine. BMJ,1998,316(7193):1230-1232
[27]于河.定性研究与肿瘤临床研究.中国中西医结合杂志,2008,28(2)：169-171
[28]Xu W, Towers AD, Li P, et al. Traditional Chinese medicine in cancer care:perspectives and experiences of patients and professionals in China. Euro J Cancer Care,2006,15(4):397-403
[29]刘建平.循证中医药定性研究方法学.北京：人民卫生出版社,2009：240-261
[30]于河.定性研究与肿瘤临床研究.中国中西医结合杂志,2008,28(2)：169-171
[1]Dicicco-Bloom B, Crabtree BF. The qualitative research interview. Med Educ,2006,40 (4):314-321
[2]Britten N,Green J. Qualitative research and evidence based medicine. BMJ,1998,316(7193):1230-1232
[3]Pieterse AH, Baas-Thijssen MC, Marijnen CA, et al. Clinician and cancer patient views on patient participation in treatment decision-making:a quantitative and qualitative exploration. Br J Cancer, 2008,99 (6):875-82
[4]Madjar I, Denham J, Rashid P. Do women have a role in early detection of prostate cancer?-Lessons from a qualitative study. Aust Fam Physician, 2007,36 (5):375-7
[5]Goel V, Gray R, Chart P, et al. Perspectives on colorectal cancer screening:a focus group study. Health Expect,2004,7(1):51-60
[6]Carney L, Jones L, Braddon F, et al.A colorectal cancer patient focus group develops an information package. Ann R Coll Surg Engl, 2006,88 (5):447-449
[7]Agincourt-Canning L. The effect of experiential knowledge on construction of risk perception in hereditary breast/ovarian cancer. J Genet Couns,2005,14(1):55-69
[8]Friedman DB, Hoffman-Goetz L. Sources of cancer information for seniors:a focus group pilot study report. J Cancer Educ,2003,8(4):15-22
[9]Wallace M, Storms S. The needs of men with prostate cancer:results of a focus group study. Appl Nurs Res,2007,20(4):181-187
[10]Reynolds MA. Hope in adults, ages 20-59, with advanced stage cancer. Palliat Support Care,2008,6(3):259-64
[11]Chapple A, Ziebland S, McPherson A. Stigma, shame, and blame experienced by patients with lung cancer:qualitative study. BMJ, 2004,328 (7454):1470
[12]Villafuerte BE, Gomez LL, Betancourt AM, et al. Cervical cancer:a qualitative study on subjectivity, family, gender and health services. Reprod Health,2007,4(5):2
[13]Anvik T, Holtedahl KA, Mikalsen H. "When patients have cancer, they stop seeing me"-the role of the general practitioner in early follow-up of patients with cancer-a qualitative study. BMC Fam Pract,2006,21(7):19
[14]Chapple A, Ziebland S, McPherson A, et al. Lung cancer patients' perceptions of access to financial benefits:a qualitative study. Br J Gen Pract,2004,54(5):589-594
[15]Liu JE, Mok E, Wong T. Caring in nursing:investigating the meaning of caring from the perspective of cancer patients in Beijing, China. J Clin Nurs,2006,15(2):188-196
[16]Worth A, Boyd K, Kendall M, et al.Out-of-hours palliative care:a qualitative study of cancer patients, carers and professionals. Br J Gen Pract,2006,56(522):6-13
[17]Hewitt ME, Bamundo A, Day R, et al. Perspectives on post-treatment cancer care:qualitative research with survivors, nurses, and physicians. J Clin Oncol,2007,25(16):2270-2273
[18]Rocco G, Lauro C, Lauro N, et al. Partial least squares path modelling for the evaluation of patients'satisfaction after thoracic surgical procedures. Eur J Cardiothorac Surg,2009,35(2):353-357
[19]Engelman KK, Cizik AM, Ellerbeck EF. Women's satisfaction with their mammography experience:results of a qualitative study. Women Health, 2005,42 (4):17-35
[20]Watanabe Y, Takahashi M, Kai I. Japanese cancer patient participation in and satisfaction with treatment-related decision-making:A qualitative study. BMC Public Health,2008,27(8):77
[21]Palmer RC, Midgette LA, Dankwa I. Colorectal cancer screening and African Americans:findings from a qualitative study. Cancer Control, 2008,15(1):72-79
[22]Odedina FT, Scrivens J, Emanuel A, et al. A focus group study of factors influencing African-American men's prostate cancer screening behavior. J Natl Med Assoc,2004,96(6):780-788
[23]Lasser KE, Ayanian JZ, Fletcher RH, et al. Barriers to colorectal cancer screening in community health centers:a qualitative study. BMC Fam Pract,2008,27 (2)9-15
[24]Lewis CL, Griffith J, Pignone MP, et al. Physicians'decisions about continuing or stopping colon cancer screening in the elderly:a qualitative study. J Gen Intern Med,2009,24(7):816-821
[25]de Salis I, Tomlin Z, Toerien M, et al. Qualitative research to improve RCT recruitment:issues arising in establishing research collaborations. Contemp Clin Trials,2008,29(5):663-670
[26]Donovan JL, Lane JA, Peters TJ, et al. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol,2009,62(1):29-36
[27]de Salis I, Tomlin Z, Toerien M, et al. Using qualitative research methods to improve recruitment to randomized controlled trials:the Quartet study. J Health Serv Res Policy,2008,13(Suppl3):92-96
[28]Zanchetta MS, Perreault M, Kaszap M, et al. Patterns in information strategies used by older men to understand and deal with prostate cancer: an application of the modelisation qualitative research design. Int J Nurs Stud,2007,44 (6):961-972
[29]Wright FC, Crooks D, Fitch M, et al. Qualitative assessment of patient experiences related to extended pelvic resection for rectal cancer. J Surg Oncol,2006,93 (2):92-99
[30]Nissim R, Regehr M, Rozmovits L, et al. Transforming the experience of cancer care:a qualitative study of a hospital-based volunteer psychosocial support service. Support Care Cancer,2009,17(7):801-809
[31]Xu W, Towers AD, Li P, et al. Traditional Chinese medicine in cancer care:perspectives and experiences of patients and professionals in China. Euro J Cancer Care,2006,15(4):397-403
[32]刘建平.循证中医药定性研究方法学.北京：人民卫生出版社,2009：240-261
[33]王建彬,杨宇飞.定性研究在中医药防治肿瘤研究中的应用.北京中医药大学学报,2009,32(5)：296-298