A Prospective Multi-Centered Registry-Based Observational Study for Patients With Cancer: Design and Rationale for Korean Medicine Cancer Registry (KMCARE).

IF 2.9 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Integrative Cancer Therapies Pub Date : 2024-01-01 DOI:10.1177/15347354231223496
Jee Young Lee, Hayun Jin, Su Bin Park, Eun Hye Kim, Jee-Hyun Yoon, Seong Woo Yoon
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Abstract

Background: Cancer is one of the leading causes of death in most countries with an expected increased burden on healthcare systems. Since integrative medical treatments are not collected within the scope of existing cancer registries, the establishment of the Korean Medicine Cancer Registry (KMCARE), gathering integrative therapies, including conservative care and Korean medicine, is warranted.

Methods: A prospective observational study based on the registry will be conducted in 5 Korean medical hospitals. A total of 650 eligible participants undergoing Korean medicine treatments within 1 month of a diagnosis of lung, colorectal, stomach, or breast cancer are anticipated to be enrolled in the registry. Data collected in the KMCARE can be classified into patient information, received treatments, and outcomes. The primary outcome is the Functional Assessment of Cancer Therapy-General Questionnaire score at 3 months. Secondary outcomes include the MD Anderson Symptom Inventory-Core and the Body Constitution Questionnaire at 3 and 6 months. After 6 months of follow-up periods, survival surveillance will be continued for additional 18 months. Descriptive and statistical analysis of primary and secondary outcomes, baseline data, safety, survival, and prognostic factors will be performed.

Discussion: This is the first prospective, multi-centered, registry-based observational study of cancer patients in Korean medicine hospitals, which could reveal the current status of cancer patients receiving integrative cancer therapies, and provide better insight into the role of Korean medicine in palliative care for patients with cancer.

Trial registration: Clinical Research Information Service (CRIS), KCT0007447.

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以癌症患者为对象的多中心登记为基础的前瞻性观察研究:韩国医学癌症登记处(KMCARE)的设计与原理。
背景:癌症是大多数国家的主要死因之一,预计会增加医疗系统的负担。由于现有的癌症登记处并未收集综合疗法,因此有必要建立韩国医学癌症登记处(KMCARE),收集包括保守治疗和韩国医学在内的综合疗法:方法:将在 5 家韩国医疗医院开展基于登记处的前瞻性观察研究。预计共有 650 名符合条件的参与者将在确诊肺癌、结直肠癌、胃癌或乳腺癌后 1 个月内接受韩医治疗。KMCARE 收集的数据可分为患者信息、接受的治疗和结果。主要结果是 3 个月时的癌症治疗功能评估-一般问卷得分。次要结果包括 3 个月和 6 个月时的 MD 安德森症状量表(MD Anderson Symptom Inventory-Core)和体质问卷(Body Constitution Questionnaire)。随访 6 个月后,将继续进行 18 个月的生存监测。将对主要和次要结果、基线数据、安全性、存活率和预后因素进行描述性分析和统计分析:讨论:这是首个针对韩医医院癌症患者的前瞻性、多中心、基于登记的观察性研究,可以揭示癌症患者接受癌症综合疗法的现状,更好地了解韩医在癌症患者姑息治疗中的作用:试验注册:临床研究信息服务(CRIS),KCT0007447。
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来源期刊
Integrative Cancer Therapies
Integrative Cancer Therapies 医学-全科医学与补充医学
CiteScore
4.80
自引率
3.40%
发文量
78
审稿时长
>12 weeks
期刊介绍: ICT is the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. Contributors are leading oncologists, researchers, nurses, and health-care professionals.
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