【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

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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

靶点

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

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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

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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

实际入组人数

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

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

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试验机构

香港中文大學醫學院那打素護理學院

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