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临床试验/NCT01797354
NCT01797354已完成2 期

Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment

Université Libre de Bruxelles2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
260
试验地点
2
主要终点
Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...

研究概览

简要总结

Background: The end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. Specific interventions adapted to this post-treatment period need thus to be designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. However, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. This study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation.

Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. Patients will be assessed at three time points during the first year following the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment. Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks.

Discussion: It is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. Results of this study will contribute to improving post-treatment care for breast cancer patients.

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
None

入排标准

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

入选标准

  • Non-metastatic breast cancer (in situ or invesive)
  • End of active treatments (surgery, chemotherapy and radiotherapy)
  • No recurrence nor palliative care
  • Min. 18 years
  • Able to speak French
  • Willing to be randomized to study intervention group
  • Accept to give their written informed consent

排除标准

  • No cognitive dysfunction
  • No severe or uncontrolled psychiatric illness

结局指标

主要结局

Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...

时间窗: Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.

Questionnaires: * the Hospital Anxiety and Depression Scale * the Rosenberg's Self-Esteem * the Mental Adjustment to Cancer Scale * the Fear of Cancer Recurrence Inventory * the Perceived Social Support Questionnaire * the Courtauld Emotional Control scale * the Ways of Coping Checklist * the Toronto Alexithymia Scale * a questionnaire about usual emotional state * a questionnaire about the use of relaxation techniques and self-hypnosis

Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)

时间窗: Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3)

Questionnaires: * Quality of life questionnaires: "EORTC QLQ-C30" and "EORTC-BR23" * Edmonton symptom evaluation scale * Way of life questionnaire

次要结局

未报告次要终点

研究者

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

Prof. Isabelle Merckaert

PhD, professor

Université Libre de Bruxelles

研究点 (2)

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