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    【ChiCTR2100047819】The Effects of Multi-modal Intervention in Managing Symptom Cluster of Cancer-Related Fatigue-Sleeping Problem-Depressed Mood in Breast Cancer Patients undergoing Chemotherapy: A Randomized Controlled Trial

    基本信息
    登记号

    ChiCTR2100047819

    试验状态

    尚未开始

    药物名称

    /

    药物类型

    /

    规范名称

    /

    首次公示信息日的期

    2021-06-27

    临床申请受理号

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    靶点

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    适应症

    乳腺癌

    试验通俗题目

    The Effects of Multi-modal Intervention in Managing Symptom Cluster of Cancer-Related Fatigue-Sleeping Problem-Depressed Mood in Breast Cancer Patients undergoing Chemotherapy: A Randomized Controlled Trial

    试验专业题目

    The Effects of Multi-modal Intervention in Managing Symptom Cluster of Cancer-Related Fatigue-Sleeping Problem-Depressed Mood in Breast Cancer Patients undergoing Chemotherapy: A Randomized Controlled Trial

    申办单位信息
    申请人联系人
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    临床试验信息
    试验目的

    The aim of this study is to examine the effect of multi-modal intervention in managing F-S-D cluster in BC patients undergoing chemotherapy in Hong Kong. The objectives are to investigate the effect of multimodal intervention on 1. CRF 2. sleeping quality 3. depressed mood 4. QOL in BC patients undergoing chemotherapy in Hong Kong

    试验分类
    试验类型

    随机平行对照

    试验分期

    其它

    随机化

    All eligible participants are randomized into experimental or controls group through permuted block randomization with a block size of 4 and 6. The randomization sequence will be performed by a research assistant.

    盲法

    Control group will receive one education session (around 10 minutes) on the side effect of chemotherapy and their management. A paper material will be given to them. Two phones follow-up sessions (approximately 15-20 minutes in each session) will be provided to them to reinforce their knowledge on the side effects of chemotherapy and their management at week four and week seven. After completion of follow-up timepoint measurement, participants will receive the education booklet used in intervention group. All participants in control and experimental group are advised not to disclose the intervention to others.

    试验项目经费来源

    No funding

    试验范围

    /

    目标入组人数

    59

    实际入组人数

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    第一例入组时间

    2021-07-01

    试验终止时间

    2022-10-31

    是否属于一致性

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    入选标准

    The inclusion criteria for this study are patients with histologically proven BC; stage 1-3; aged >=18 years old; scheduled for adjuvant or neoadjuvant chemotherapy; Eastern Cooperative Oncology Group Performance Status from 0 to 1; able to communicate in Cantonese and read Chinese; available to be contacted by telephone.；

    排除标准

    The exclusion criteria are patients who are receiving treatment for mental disorders; diagnosis of cognitive impairment e.g., dementia; pregnancy; refused to participate; unable to communicate in Cantonese or read Chinese; illiterates; mentally incapacitated person.；

    研究者信息
    研究负责人姓名
    试验机构

    香港中文大學醫學院那打素護理學院

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

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