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临床试验/NCT02569294
NCT02569294已完成不适用

Feasibility and Impact of Yoga, Self-hypnosis and Cognitive-behavioral Group Interventions in Improving Well-being of Breast Cancer Patients

University of Liege2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
Interest of patients in the three groups

研究概览

简要总结

This is a clinical non-randomized prospective study. This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer, at three times after the end of the interventions (just after the end, at a 3-month and at a 9-month follow-up).

详细描述

This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (cognitive-behavioral therapy, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer.

Eligible breast cancer patients were identified through an institutional database or by referring physicians and were approached by phone to inform them of the intervention. They were given a choice between the three group interventions: CBT, yoga and self-hypnosis. Patients who agreed not to participate in any of the interventions were included in the control group. After giving written informed consent, patients completed a baseline assessment including self-reported measures. Follow-up assessment was conducted one week after the group intervention, and at a 3-month and 9-month follow-up. Interventions were proposed according to previous results showing the patient's interest in CBT, yoga and self-hypnosis, and the expertise of the team. Each intervention included 6 sessions of 1.5 hours.

The primary outcome measure was the interest in the three interventions (participation rate in each group). Since the study was first designed to determine interest, no sample size calculation was performed. Secondary outcomes were responses concerning emotional distress, QoL, sleep quality and mental adjustment to cancer assessed with self-reported questionnaires before and after the group interventions.

Descriptive statistics (percentages, means and standard deviation (SD)) were used to describe the proportions of patients who were interested in the group interventions and to examine their demographic, medical and psychological data. Baseline time 0 demographic, medical and psychological data were compared between groups to test for initial group equivalency using inferential statistics: analysis of variance (ANOVA) and Chi-square test, as appropriate. To be considered for the data analysis, patients had to attend at least three sessions. Multivariate analyses were calculated regarding group interventions and time of medical treatments (during or after chemo/radiation therapy). The pre- and post-assessment comparison of each measure within each group was made using the Wilcoxon test for matched pairs. All statistical tests were two-tailed, and a P-value <0.05 was considered statistically significant. Investigators also calculated Cohen's d effect size for each group. The analyses were performed with SPSS Version 21.0 (IBM Corp., Armonk, N.Y).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • first breast cancer without metastases
  • between 18 and 75-year-old
  • ability to read, write and speak French.

排除标准

  • Patients with a diagnosed psychiatric disorder or dementia

研究组 & 干预措施

Choice 1: Yoga intervention

Experimental

See intervention description

干预措施: Yoga intervention (Behavioral)

Choice 2: Hypnosis intervention

Experimental

See intervention description

干预措施: Hypnosis intervention (Behavioral)

Choice 3: CBT intervention

Experimental

See intervention description

干预措施: CBT intervention (Behavioral)

Control group

No Intervention

Participants who agreed not to participate in any of the interventions proposed.

结局指标

主要结局

Interest of patients in the three groups

时间窗: 3 years

The first outcome is to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate in each group (N and %).

Reasons for choosing a particular group

时间窗: 3 years

The second outcome is to determine the reasons for choosing a particular group (open question).

Reasons for declining to participate

时间窗: 3 years

The third outcome is to determine the reasons for declining to participate to the groups (open question).

次要结局

  • Mental adjustment to cancer(4 years)
  • Emotional distress(4 years)
  • Quality of Life(4 years)
  • Quality of sleep(4 years)

研究者

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

Isabelle Bragard

Ph.D.

University of Liege

研究点 (2)

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