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临床试验/NCT05327153
NCT05327153招募中不适用

The Efficacy of Acceptance and Commitment Therapy (ACT) on Disease Acceptance and Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients

研究概览

简要总结

The psychological rehabilitation of breast cancer patients plays an important role in the whole process of disease rehabilitation. In this paper, patients with breast cancer were treated with ACT group intervention for a period of four weeks to improve their disease acceptance and psychological flexibility, so as to improve their quality of life. Finally, its effect and mechanism are explored by covariance analysis and mediation analysis. The significant findings of this study will provide the quality of life changes in breast cancer patients and how did these changes happen and the moderating role of social support in the process of intervention.

详细描述

This is a randomized controlled trial that examines the efficacy of brief acceptance and commitment therapy by comparing the differences between ACT intervention (cases) and waitlist (control). The inclusion criteria are breast cancer patients must be 18 years old and above, early stage of breast cancer (stages 1 to 3), newly diagnosed breast cancer patients in the treatment phase and know about the illness (before and after surgery), have basic writing, reading, and verbal communication skills and volunteer to participate in this study. The exclusion criteria including patients with metastatic or recurrent breast cancer or other malignant tumors, patients had participated ACT intervention before, patients who were diagnosed with psychoses, substances abuser and people who previously exposed to chemotherapy. Respondents will be randomly recruited based on odd and even sequences. Those who are in odd sequence will be assigned into group A, and those who are in even sequence will be assigned into group B. It is stipulated that group A is the intervention group and group B is the control group. The respondents will not know in which group that they belong to ensure the single blinding process. Breast cancer patients from Breast Clinic, IPPT who met the inclusion criteria will be approached andinformed about the study and procedure will be given. Once the respondent agrees to participate, informed consent will be obtained.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •breast cancer patients must be 18 years old and above
  • •early stage of breast cancer (stages 1 to 3)
  • •newly diagnosed breast cancer patients in the treatment phase
  • •know about the illness (before and after surgery)
  • •have basic writing, reading, and verbal communication skills
  • •volunteer to participate in this study

排除标准

  • •breast cancer patients with more than 65 years old
  • •patients with metastatic or recurrent breast cancer or other malignant tumors
  • •patients had participated ACT intervention before
  • •patients who were diagnosed with psychoses, substances abuser
  • •people who previously exposed to chemotherapy.

研究组 & 干预措施

intervention group

Experimental

Breast cancer patients from the IPPT Breast Clinic who meet the inclusion criteria will be contacted and informed about the study and procedure. Informed consent will be obtained once the respondent agrees to participate. In the case of group psychological intervention, 8 breast cancer patients form one group, and group psychological intervention is given once a week for four weeks as part of the treatment process. The batteries of assessment were carried out at 3-time points; pre-intervention, post-intervention, and 3 months after the intervention.

干预措施: Acceptance and Commitment Therapy (Behavioral)

waitlist group

Other

After the intervention of the intervention group, the waitlist group was interfered again. The batteries of assessment was same as the intervention group.

干预措施: Acceptance and Commitment Therapy (Behavioral)

结局指标

主要结局

To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients

时间窗: 10 months

The hypothesis is that Acceptance and Commitment Therapy helps improve disease acceptance and quality of life in breast cancer patients. The study collected data through questionnaires. ANCOVA will be employed to examine the significant differences of measured variables between waitlist and intervention groups whilst controlling the covariates.

次要结局

  • The mechanism between acceptance and commitment therapy with disease acceptance and quality of life in breast cancer patients(1 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Song Wenjun

doctor

Universiti Sains Malaysia

研究点 (1)

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