Improving Emotion Regulation at the End of Breast Cancer Treatment: A Randomized Controlled Study Assessing the Impact of a Multi-Component Psychological Group Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Patients' Depression State through the Hospital Anxiety Depression Scale (HADS)
研究概览
简要总结
The end of treatment marks the beginning of a challenging period for breast cancer patients. While this period often provokes a sense of relief, it can also be a source of apprehension and vulnerability regarding the future. Patients may be brought to feel contradictory thoughts and emotions impacting their quality of life such as anxiety linked to uncertainty and fear of cancer recurrence. In order to accompany breast cancer patients during this transition period and to address these emotional difficulties, the Institut Jules Bordet has launched an 8-session psychological multi-component group intervention. Its objective is to bring patients tools and competencies (e.g., hypnosis, treatment of intrusive thoughts, learning to cope with uncertainty, attention reorientation toward positive thoughts) to promote emotion management and well-being.
详细描述
- Introduction
At the end of treatment, breast cancer patients are confronted with the short- and long-term physical (e.g., fatigue, pain, hot flashes) and psychological (e.g., anxiety, fear of recurrence, depressive symptoms) consequences of cancer diagnosis and treatment (Costanzo et al., 2007 ; Stanton et al., 2005). Emotion dysregulation (e.g., anxiety, fear of recurrence (Devine & Westlake,1995), depressive symptoms (Stanton, 2006)) is, with fatigue (Jacobsen & Jim, 2008) and cognitive dysfunctions (Duijts et al., 2011), one of the three most common complaints. Nevertheless, few psychological interventions have focused on this period (Jacobsen & Jim, 2008 ; Stanton et al., 2005 ; Stanton, 2006) and no intervention has specifically addressed emotion regulation of breast cancer survivors (Devine & Westlake, 1995 ; Duijts et al., 2011 ; Sheard & Maguire, 1999).
Little is known about the required components of psychological interventions designed to support patients facing these challenges. Meta-analyses (Naaman et al., 2009 ; Osborn, 2006 ; Sheard & Maguire, 1999) and one review (Traeger et al., 2012) have described various components of interventions used to address anxiety and depressive symptoms in cancer care, such as mindfulness (Lengacher et al., 2009 ; Würtzen et al., 2013), education (Björneklett et al., 2012 ; Dolbeault et al., 2009 ; Duijts et al., 2011 ; Fors et al., 2011 ; Osborn, 2006 ; Scheier et al., 2005), cognitive-behavioral therapy (Dolbeault et al., 2009 ; Duijts et al., 2012 ; Fors et al., 2011 ; Osborn, 2006 ; Savard et al., 2005 ; Savard et al., 2005), support groups (Björneklett et al., 2012 ; Fors et al., 2011 ; Montazeri et al., 2001), and relaxation training (Björneklett et al., 2012 ; Elsesser, Van Berkel & Sartory, 1994 ; Hidderley & Holt, 2004). These interventions taken individually presented moderate effect sizes (Naaman et al., 2009), suggesting the need to combine components.
During the last four years, our team conducted a study designed to compare the benefits in terms of emotion regulation of a 15-session single-component group intervention (SGI) based only on support with those of a 15-session multi-component group intervention (MGI) combining support with cognitive-behavioral and hypnosis components. The cognitive-behavioral therapy (CBT) components were chosen because interventions using such components have shown larger effect sizes than interventions using other components in previous studies on the treatment of anxiety-related conditions (Chambless & Ollendick, 2001 ; Deacon & Abramowitz, 2004 ; Norton & Price, 2007 ; Osborn, 2006 ; Stewart & Chambless, 2009). The hypnosis component was chosen because some reviews have suggested that self-hypnosis training is a rapid, cost-effective, and safe alternative to medication for the treatment of such conditions. Moreover, a meta-analysis showed that the addition of hypnosis to cognitive-behavioral component enhances effect sizes of interventions (Kirsch, Montgomery & Sapirstein, 1995) . Results of this study have shown the acceptability of such an intervention after active treatment (Merckaert et al., 2015). They have also indicated that an MGI combining support with CBT and hypnosis is clinically useful for patients with breast cancer after radiotherapy. Our results confirm the need to design specific interventions targeting anxiety regulation, fear of recurrence, and depressive symptoms. They also underline the necessity of intensifying interventions through including other components (e.g., emotion regulation, repetitive exposures to fear, treatment of intrusive thoughts, attention reorientation). 2. Objectives of the study
The primary aims of this study are to evaluate in a randomized controlled trial (RCT) the efficacy of an 8-session multi-component group intervention extended over 4 months in promoting emotion regulation (in an emotion regulation task and in everyday life) and patient emotional well-being compared with a waiting-list control group. The secondary aims are to evaluate patients' satisfaction with the program, hypnosis/relaxation practice in everyday life, mental adjustment, and changes in patients' level of attentional bias toward cancer threat and physical activity. 3. Participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Experiencing moderate to high emotion dysregulation (one to four scores = or > 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts)
- •Non-metastatic breast cancer
- •Post chimiotherapy, radiotherapy, surgery treatment
- •Age > 18 years
- •Completing a written informed consent
排除标准
- •Non-fluency in French
- •Severe cognitive impairment
- •Severe and/or acute psychiatric disorder.
结局指标
主要结局
Change in Patients' Depression State through the Hospital Anxiety Depression Scale (HADS)
时间窗: Change from T1 (baseline) Depression State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Depression State at T3 (4 months after T2) for the CG
Change in patients' emotional state will be assessed in terms of depression: Depression is assessed by the Hospital Anxiety Depression Scale - depression 7-item ordinal self-report subscale (Duijts et al., 2012 ; Naaman et al., 2009). Each item is scored from 0 to 3. The subscale score ranges from 0 to 21. A subscale score from 0 to 7 is considered as normal, from 8 to 10 as an adaptation disorder, and from 11 to 21 as a mood disorder.
Change in Patients' Fear of Cancer Recurrence State through the Fear of Cancer Recurrence Inventory (FCRI)
时间窗: Change from T1 (baseline) Fear of Cancer Recurrence State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Fear of Cancer Recurrence State at T3 (4 months after T2) for the CG
Change in patients' emotional state will be assessed in terms of fear of cancer recurrence: Fear of cancer recurrence is assessed by the Fear of Cancer Recurrence Inventory (FCRI). It is a 42-item 5-point ordinal self-report scale including seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance (Simard \& Savard, 2009). A higher score indicates higher levels of fear of cancer recurrence.
Change in Patients' Subjective Emotion Regulation through six 10-cm visual analog scales assessing anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels
时间窗: Change from T1 (baseline) Patients' Subjective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Patients' Subjective Emotion Regulation at T3 (4 months after T2) for the CG
Change in patients' subjective emotion regulation will be examined using the Emotion Regulation Task. Patients are asked to self-report their anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels just after both exposures to anxiety triggers (the Mental Adjustment to Cancer Scale (MAC)) and the Impact of Cancer questionnaire Version 2 (IOCv2)) and regulation exercises (self-relaxation and induced relaxation) using six 10-cm visual analog scales (VAS; with the extreme left defined as "not at all" and the extreme right defined as "extremely"). VAS are used because such scales have been shown to be appropriate and adequate for the assessment of emotional states (Davey et al., 2007; Wewers \& Lowe, 1990).
Change in Patients' Objective Emotion Regulation through an ambulatory digital Holter recording heart rate (beats per minute)
时间窗: Change from T1 (baseline) Patients' Objective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 monts after T2) for the EG; Change from T2 Patients' Objective Emotion Regulation at T3 (4 monts after T2) for the CG
Change in patients' objective emotion regulation will be examined using the Emotion Regulation Task. Heart rate (beats per minute) is measured throughout the Emotion Regulation Task using an ambulatory digital Holter recorder.
Change in Patients' Emotion Regulation in their Everyday Life through an ecological momentary assessment
时间窗: Change from T1 (baseline) Emotion Regulation in their Everyday Life at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Emotion Regulation in their Everyday Life at T3 (4 months after T2) for the CG
Change in patients' emotion regulation in their everyday life will be assessed through an ecological momentary assessment (EMA) procedure during 7 days. The EMA procedure will allow to observe the evolution of the ratio between positive and negative emotions in patients' everyday life (Fredrickson \& Losada, 2005).
Change in Patients' Anxiety State through the Hospital Anxiety Depression Scale (HADS) - anxiety subscale and the Penn State Worry Questionnaire (PSWQ)
时间窗: Change from T1 (baseline) Anxiety State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Anxiety State at T3 (4 months after T2) for the CG
Change in patients' emotional state will be assessed in terms of anxiety: Anxiety is assessed by the Hospital Anxiety Depression Scale (HADS) - anxiety 7-item ordinal self-report subscale (Duijts et al., 2012 ; Naaman et al., 2009). Each item is scored from 0 to 3. The subscale score ranges from 0 to 21. A subscale score from 0 to 7 is considered as normal, from 8 to 10 as an adaptation disorder, and from 11 to 21 as a mood disorder. Anxiety is also assessed by the 16-item ordinal self-report Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990). Each item is scored from 1 ("not at all typical of me") to 5 ("very typical of me"). The total scale score ranges from 16 to 80, with higher scores reflecting greater levels of pathological worry.
次要结局
- Change in the Multidimensional Fatigue Inventory (MFI-20)(Change from T1 (baseline) MFI-20 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MFI-20 at T3 (4 months after T2) for the CG)
- Change in a Life Event Questionnaire(Change from T1 (baseline) Life Event Questionnaire at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Life Event Questionnaire at T3 (4 months after T2) for the CG)
- Change in Attentional Bias through a dot probe task(Change from T1 (baseline) Attentional Bias at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Attentional Bias at T3 (4 months after T2) for the CG)
- Change in the Mental Adjustment to Cancer Scale (MAC)(Change from T1 (baseline) MAC at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MAC at T3 (4 months after T2) for the CG)
- Change in Penn State Worry Questionnaire (PSWQ)(Change from T1 (baseline) PSWQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 PSWQ at T3 (4 months after T2) for the CG)
- Change in the Five Facet of Mindfulness Questionnaire (FFMQ)(Change from T1 (baseline) FFMQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FFMQ at T3 (4 months after T2) for the CG)
- Change in the Metacognitions About Health Anxiety Questionnaire (MCQ-30)(Change from T1 (baseline) MCQ-30 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MCQ-30 at T3 (4 months after T2) for the CG)
- Change in the Insomnia Severity Index (ISI)(Change from T1 (baseline) ISI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ISI at T3 (4 months after T2) for the CG)
- Change in an adapted Emotion Symptom Assessment Scale (ESAS)(Change from T1 (baseline) ESAS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ESAS at T3 (4 months after T2) for the CG)
- Change in the Hospital Anxiety and Depression Scale (HADS) Questionnaire(Change from T1 (baseline) HADS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 HADS at T3 (4 months after T2) for the CG)
- Change in the Fear of Cancer Recurrence Inventory (FCRI) Questionnaire(Change from T1 (baseline) FCRI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FCRI at T3 (4 months after T2) for the CG)
- Change in the White Bear Suppression Inventory (WBSI)(Change from T1 (baseline) WBSI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 WBSI at T3 (4 months after T2) for the CG)
- Change in Ecological Momentary Assessment through the use of a pedometer and a measure of cardio frequency (Garmin vívoactive® HR)(Change from T1 (baseline) Heart Rate, Physical Activiy and Sleep Patterns at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Ecological Momentary Assessment at T3 (4 months after T2) for the CG)
- Change in the Impact of Cancer Scale (IOCv2)(Change from T1 (baseline) IOCv2 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 IOCv2 at T3 (4 months after T2) for the CG)
- Change in the Cognitive Emotion Regulation Questionnaire (CERQ)(Change from T1 (baseline) CERQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 CERQ at T3 (4 months after T2) for the CG)
研究者
Prof. Isabelle Merckaert
PhD, Professor
Université Libre de Bruxelles