Improving Emotion Regulation at the End of Breast Cancer Treatment

Breast Cancer Clinical Trial

Official title: Improving Emotion Regulation at the End of Breast Cancer Treatment: A Randomized Controlled Study Assessing the Impact of a Multi-Component Psychological Group Intervention

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

1. 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 Patients who have been treated for a non-metastatic breast cancer will be approached at the end of active cancer treatment (i.e., surgery, chemotherapy, and radiotherapy) in order to be screened for emotion dysregulation. Patients 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) will be offered the intervention. 4. Intervention 4.1. Theoretical framework This is a multi-component group intervention integrating an emotion regulation and an exposure to fear component. 4.1.1. The emotion regulation component builds upon the Adaptive Coping with Emotions Model which was developed to provide a conceptualization of adaptive emotion regulation. It aims to help patients to better identify their physical, emotional and behavioral responses to their positive and negative emotions in order to be able to better regulate or acknowledge those emotions. This component integrates a self-regulation component. The self-regulation component relies on a phone app-based coaching intervention aiming at promoting changes in patients' ability to regulate their emotions in their everyday life. It aims at promoting patients' self-awareness of their internal states, orientating their attention consciously toward positive stimuli and at developing physical activity. Hypnosis is used as hetero-hypnosis in each session and aims at deepening the development of patients' emotion regulation skills. Recordings of the exercises done in session are transmitted to the patients in order to promote use of the technique at home. Helping patients develop autohypnosis skills is important as it may allow them to better regulate their emotions in everyday life. 4.1.2. The exposure to fear component aims at helping patients deal with their fear of death. Just as anxiety is a normal emotion, anxiety concerning death is also a normal experience. The modest level of death anxiety that most people experience in everyday life may increase dramatically when one experiences a period of health problems, illness, or death of someone close (Kastenbaum, 2000). This part of the intervention will be based on worry exposure. This part of the intervention targets cancer-related worry and is based on Borkovec's avoidance theory of worry (Borkovec et al., 1998). Worry is a predominantly cognitive-verbal activity that inhibits full emotional processing. As a result, disturbing emotional meanings of potentially dangerous and anxiously anticipated events cannot be fully tested or altered, making the repetitive processing of the feared stimuli probable (Foa & Kozak, 1986). Given that cancer-recurrence related-worry is typically characterized by the focus on one hypothetical future event, it follows that exposure with imagined stimuli could be a crucial component of the treatment of fear of recurrence. The intervention will be based on two exercises. In the first, patients will be accompanied through a hypnosis based exposure to a major trigger of fear of recurrence that is the anticipation of the cancer check-up. This exercise is designed to help patients experience the emotions which may arise in this context while being guided through their resolution and regulation. The second exercise aims at helping them overcome their fear of recurrence through discussing their worst-case scenario in the group. The scenario are then discussed in order to highlight which part of them could be modified because it is unrealistic or because patients have more resources than they anticipate. 4.2. Study design and assessment schedule This is a two-armed, randomized, waiting-list controlled trial. Patients who agree to participate will be randomly assigned to two groups: 1) the experimental group (EG) where six patients will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis; and 2) the waiting-list control group (CG) where six patients will receive the same intervention 4 months later. Patients will be assessed at three time points: 1) at baseline (T1), 2) 4 months later (T2), that means just after the intervention for the experimental group (EG) and just before the intervention for the control group (CG), and 3) 4 months later (T3), that means 4 months after the T2 for the experimental group and just after the intervention for the control group (CG). 4.2.1. Pre-assessment screening Before inclusion in the study, during the last weeks of treatment (T0), approached patients will complete a socio-demographic questionnaire, a screening of life habits and difficulties questionnaire, an adapted Edmonton symptom evaluation scale (Chang, Hwang & Feuerman, 2000) (assessing pain, fatigue, sleep disturbances, fatigue, difficulty concentrating, memory loss, feeling of malaise, hot flashes, depression, anxiety, fear of recurrence, and worry), the Hospital anxiety and depression scale (HADS) (Zigmond & Snaith, 1983), and the Fear of Cancer Recurrence Inventory Severity sub-scale (Simard & Savard, 2009). Patients will report medical information about their disease, previous and current treatment and prognosis. This screening allows checking for inclusion and exclusion criteria and comparing patients who accept and refuse the intervention. 4.2.2. Assessment procedure Each assessment procedure (i.e., T1, T2, T3) includes three parts: an emotion regulation task, an ecological momentary assessment and an attentional bias task. Two months after T1 and T2, the experimental (EG) and control (CG) groups will be contacted once by phone to complete a phone-based questionnaire to assess their usual care use. 4.2.2.1. Emotion regulation task This assessment procedure has been used in a previous project and provides a dynamic picture of patients' emotion regulation. Each assessment session will first involve completion of questionnaires and two emotion regulation exercises: (1) 4 min exposure to anxiety triggers through completion of the Mental Adjustment to Cancer Scale (Watson et al., 1988), followed by a 12-min self-relaxation exercise in which patients will be asked to relax by using their own strategies; and (2) 4 min exposure to anxiety triggers through completion of the Impact of Cancer Questionnaire (Zebrack et al., 2006), followed by a 12-min guided hypnosis exercise in which patients will be asked to listen to an audio recording of a hypnotic induction script. The subtasks will be separated by a period of questionnaires completion. Patients' emotion regulation will be measured physiologically (heart rate measurement) and psychologically (anxiety, sadness, fear of recurrence and energy state-levels). 4.2.2.2. Ecological momentary assessment (EMA) Patients' emotion regulation in their everyday life will be assessed during 9 days through an ecological momentary assessment (EMA) procedure. Firstly, patients will be asked 5 times a day to select on a list of 20 emotions the 2 or 3 that they were experiencing during the minutes before they saw the notification. For each emotion experienced, they will have to report its intensity on a 10-point Likert scale ranging from 1 to 10. They will have to report to what extent they have felt able to control those emotions and have felt submerged by those emotions. They will report whether during those minutes they had been thinking about something other than what they were currently doing. They will have to answer with one of four options: no; yes, something pleasant; yes, something neutral; or yes, something unpleasant (Killingsworth & Gilbert, 2010). Finally, they will be asked their level of fatigue and energy. Prompts will be sent randomly from 9 AM to 7,5 PM through the use of the software from http://www.lifedatacorp.com/. Secondly, each evening for 9 consecutive days, patients will have to indicate on the same list of 20 emotions (10 positive and 10 negative emotions), the extent to which they have felt each of the 20 emotions in the past 24 hours and their level of fatigue, from 0 (not at all) to 4 (extremely) (Fredrickson et al., 2003). In order to insure confidentiality, subjects will be provided with an iPod Touch. The two first days of data collection will be used as a training for participants and only their responses on the 7 following days will be taken into consideration. Thirdly, patients will be provided with an armband to continuously record during those 9 days, their heart rate levels, physical activity levels (pedometer and accelerometer) and sleep patterns (Garmin vívoactive HR). 4.2.2.3. Attentional bias task Patients will complete an attentional bias computer task assessing attentional orientation toward emotional information. An adaptive function of biased attentional orientation toward negative information is to facilitate detection of danger in the environment and to help the organism respond effectively to threatening situations (Bar-Haim et al., 2007). When anxiety symptoms become excessive, biased attentional orientation toward negative information may have detrimental effects on patients' cognitive (e.g., intrusive thoughts, misinterpretation), behavioral (e.g., body screening, future planning difficulties), emotional (e.g., negative affects, panic attacks), and physiological status (e.g., physiological stress activation), and may play a prominent role in the etiology and maintenance of anxiety disorders (Bar-Haim et al., 2007). Computer tasks have been used to study the threat-related attentional bias in anxiety. ;

Related Conditions & MeSH terms

• Affective Symptoms
• Anxiety Depression
• Breast Cancer
• Breast Neoplasms
• Emotional Disturbances
• Emotional Dysfunction
• Fear of Cancer

• NCT number: NCT03336827
• Study type: Interventional
• Source: Université Libre de Bruxelles
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Completion date: February 28, 2020