Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
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
- 否
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
Prof. Isabelle Merckaert
PhD, professor
Université Libre de Bruxelles
