{"title":"中医药联合在线团体心理治疗(TCM-eRhab)对提高结直肠癌幸存者生活质量和减轻心理负担的疗效:II期随机对照试验的研究方案。","authors":"Yunzi Yan, Jiaxi Liu, Ying Pang, Zixu Wang, Rongyan Peng, Demei Jiang, Yufei Yang, Lili Tang, Lingyun Sun","doi":"10.1186/s12906-024-04533-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>More than 50% of colorectal cancer(CRC) patients experience cancer-related psychological burden after radical surgery, which can seriously affect their physical wellness, quality of life and even survival outcomes. Our research team developed a six-week Traditional Chinese Medicine Combined Online Group Psychotherapy (TCM-eRhab) and proved its efficacy on relieving cancer-related anxiety, depression and fear of cancer recurrence though phase I single arm clinical trial (n = 40). Large sample size randomized controlled clinical trial(RCT) is necessary to further evaluate TCM-eRhab's role on improving quality of life and survival outcomes among this population.</p><p><strong>Methods: </strong>We design a phase II RCT study, in which 210 CRC patients who have received radical surgery (stage I-III) will be recruited. Eligible patients will be randomly assigned to TCM-eRhab group or usual care group by 2:1 ratio. Patients in the intervention group will receive the structured TCM-eRhab program for six weeks, while patients in control group will receive usual care only. The primary outcomes are quality of life, severity of anxiety, depression and fear of cancer recurrence. Cancer recurrence rate will also be calculated according to long term follow-up data.</p><p><strong>Discussion: </strong>As one of the first RCTs to evaluate the impacts of TCM combined psychological therapy to improve CRC patients' quality of life after surgery, the results from this study will provide innovative knowledge and evidence on integrating TCM into CRC survivorship care and mind-body intervention model.</p>","PeriodicalId":9128,"journal":{"name":"BMC Complementary Medicine and Therapies","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11290286/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy of Traditional Chinese Medicine Combined Online Group Psychotherapy (TCM-eRhab) on improving quality of life and relieving psychological burden for colorectal cancer survivors: a study protocol for a phase-II randomized controlled trial.\",\"authors\":\"Yunzi Yan, Jiaxi Liu, Ying Pang, Zixu Wang, Rongyan Peng, Demei Jiang, Yufei Yang, Lili Tang, Lingyun Sun\",\"doi\":\"10.1186/s12906-024-04533-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>More than 50% of colorectal cancer(CRC) patients experience cancer-related psychological burden after radical surgery, which can seriously affect their physical wellness, quality of life and even survival outcomes. Our research team developed a six-week Traditional Chinese Medicine Combined Online Group Psychotherapy (TCM-eRhab) and proved its efficacy on relieving cancer-related anxiety, depression and fear of cancer recurrence though phase I single arm clinical trial (n = 40). Large sample size randomized controlled clinical trial(RCT) is necessary to further evaluate TCM-eRhab's role on improving quality of life and survival outcomes among this population.</p><p><strong>Methods: </strong>We design a phase II RCT study, in which 210 CRC patients who have received radical surgery (stage I-III) will be recruited. Eligible patients will be randomly assigned to TCM-eRhab group or usual care group by 2:1 ratio. Patients in the intervention group will receive the structured TCM-eRhab program for six weeks, while patients in control group will receive usual care only. The primary outcomes are quality of life, severity of anxiety, depression and fear of cancer recurrence. Cancer recurrence rate will also be calculated according to long term follow-up data.</p><p><strong>Discussion: </strong>As one of the first RCTs to evaluate the impacts of TCM combined psychological therapy to improve CRC patients' quality of life after surgery, the results from this study will provide innovative knowledge and evidence on integrating TCM into CRC survivorship care and mind-body intervention model.</p>\",\"PeriodicalId\":9128,\"journal\":{\"name\":\"BMC Complementary Medicine and Therapies\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-07-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11290286/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Complementary Medicine and Therapies\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12906-024-04533-y\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Complementary Medicine and Therapies","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12906-024-04533-y","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
Efficacy of Traditional Chinese Medicine Combined Online Group Psychotherapy (TCM-eRhab) on improving quality of life and relieving psychological burden for colorectal cancer survivors: a study protocol for a phase-II randomized controlled trial.
Background: More than 50% of colorectal cancer(CRC) patients experience cancer-related psychological burden after radical surgery, which can seriously affect their physical wellness, quality of life and even survival outcomes. Our research team developed a six-week Traditional Chinese Medicine Combined Online Group Psychotherapy (TCM-eRhab) and proved its efficacy on relieving cancer-related anxiety, depression and fear of cancer recurrence though phase I single arm clinical trial (n = 40). Large sample size randomized controlled clinical trial(RCT) is necessary to further evaluate TCM-eRhab's role on improving quality of life and survival outcomes among this population.
Methods: We design a phase II RCT study, in which 210 CRC patients who have received radical surgery (stage I-III) will be recruited. Eligible patients will be randomly assigned to TCM-eRhab group or usual care group by 2:1 ratio. Patients in the intervention group will receive the structured TCM-eRhab program for six weeks, while patients in control group will receive usual care only. The primary outcomes are quality of life, severity of anxiety, depression and fear of cancer recurrence. Cancer recurrence rate will also be calculated according to long term follow-up data.
Discussion: As one of the first RCTs to evaluate the impacts of TCM combined psychological therapy to improve CRC patients' quality of life after surgery, the results from this study will provide innovative knowledge and evidence on integrating TCM into CRC survivorship care and mind-body intervention model.