Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

16 weekly sessions, 90 min of Supportive-expressive group therapy

The supportive-expressive group therapy (SEGT) is an intervention for women with BC that is designed to build bonds and to facilitate changes in emotional expression and regulation taking into account the role that emotions play in physiologic function, intimately related to the progression of the disease. It is based on seven main themes: building bonds, expressing feelings, detoxifying dying, reordering life priorities, improve support from and communication with family and friends, fortifying families, dealing with doctors, and control pain and anxiety. Although originally developed according to an existential perspective, recently the supportive-expressive group therapy has been used according to an attachment framework.

Supportive-expressive group therapy

Tânia Brandão, PhD Student

To test the feasibility of supportive-expressive group intervention (SEGT) for women with primary breast cancer and to provide a preliminary test of its efficacy.

This study aims to compare the efficacy of a 16-sessions group intervention (Supportive-Expressive group therapy) versus control group (no intervention) in women with primary breast cancer.

This study tries to evaluate the efficacy of SEGT on breast cancer patients' emotion regulation, social support, caregiving, and marital satisfaction, and its improvement on breast cancer patients' life quality. This study also intents to explore the moderating role of attachment on these associations.

Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer

Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention (SEGT) for Women With Breast Cancer

The World Health Organization Quality of Life - BREF

The Stanford Emotional Self-Efficacy Scale-Cancer

The Cognitive Emotion Regulation Questionnaire

The Multidimensional Scale of Perceived Social Support

Fundação para a Ciência e a Tecnologia

Centro Hospitalar de Vila Nova de Gaia/Espinho

Centro Hospitalar De São João, E.P.E.

Mama Help - Support Centre for Breast Cancer Patients

Universidade do Porto

Ph.D. Student

Anxiety Disorders

Depression

Depressive Disorder

Affective Symptoms

Behavioral Symptoms

Patients include in the experimental group (EG) will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis after the first assessment (T1) (i.e., before the second assessment taking place 4 months later (T2)). They will resort to usual care only after the second assessment (T2) (i.e., before the third assessment taking place 4 months later (T3)).

Patients include in the waiting-list control group (CG) will resort to usual care only after the first assessment (T1) (i.e., before the second assessment taking place 4 months later (T2)). They will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis after the second assessment (T2) (i.e., before the third assessment taking place 4 months later (T3)).

The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.

Cognitive-Behavioral Group Therapy and Hypnosis

Darius Razavi, Prof

Isabelle Merckaert, Prof

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.

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.

This is a two-armed, randomized, waiting-list controlled trial. Patients who agree to participate in the study 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).

Improving Emotion Regulation at the End of Breast Cancer Treatment

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

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 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 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' 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.

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' 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.

Patients will complete a self-report adapted Emotion Symptom Assessment Scale (ESAS) assessing from 0 to 10 their usual emotional and symptomatic states (i.e., pain, physical fatigue, psychological fatigue, sleeping difficulties, memory disorder, concentration disorder, feeling of discomfort, hot flushes, depression, anxiety, fear of cancer recurrence, and ruminations).

Patients will complete the Hospital Anxiety and Depression Scale (HADS) - anxiety and depression 14-item ordinal self-report subscales (Zigmond \& Snaith, 1983). Each item is scored from 0 to 3. The total score ranges from 0 to 42. A total score from 0 to 12 is considered as normal, from 13 to 18 as an adaptation disorder, and from 19 to 42 as a mood disorder.

Patients will complete the Fear of Cancer Recurrence Inventory (FCRI) (Simard \& Savard, 2009). 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.

Patients will complete the White Bear Suppression Inventory (WBSI) (Schmidt et al., 2009 ; Wegner \& Zanakos, 1994). The WBSI is a 15-item ordinal self-report measure of thought suppression. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater tendencies to suppress thoughts.

Patients will complete the Mental Adjustment to Cancer Scale (MAC) (Watson et al., 1988). The MAC is a 40-item ordinal self-report ordinal measure of five psychological dimensions of mental adjustment in cancer patients (fighting spirit, anxious preoccupation, helpless-hopelessness, fatalism, and avoidance). Each item is scored from 1 (definitely does not apply to me) to 4 (definitely applies to me).

Patients will complete 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.

Patients will complete the Five Facet of Mindfulness Questionnaire (FFMQ) (Baer et al., 2008). The FFMQ is 39-item ordinal self-report measure of five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Each item is scored from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating more mindfulness.

Patients will complete the Metacognitions About Health Anxiety Questionnaire (MCQ-30) (Wells \& Cartwright-Hatton, 2004). The MCQ-30 is a 30-item self-report measure of metacognitive beliefs (beliefs about thinking). The MCQ-30 have five subscales: cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability of thoughts and danger, and beliefs about the need to control thoughts. Each item is scored from 1 (do not agree) to 4 (agree very much). Subscale scores range from 6 to 24, and total scores range from 30 to 120, with higher scores indicating higher levels of unhelpful metacognitions.

Patients will complete the Insomnia Severity Index (ISI) (Morin et al., 2011). The ISI is a brief 7-item self-report measure of insomnia. A total score from 0 to 7 is considered as no clinically significant insomnia, from 8 to 14 as a subthreshold insomnia, from 15 to 21 as a moderate clinical insomnia, and from 22 to 28 as a severe clinical insomnia.

Patients will complete the Impact of Cancer Scale (IOCv2) (Zebrack et al., 2006). The IOCv2 is a 37-item self-report measure of the quality of life of long-term cancer survivorship. The IOCv2 consists of two higher-order scales, a Positive Impact Scale and a Negative Impact Scale, each with four subscales: Altruism and empathy, health awareness, meaning of cancer, and positive self-evaluation subscales for the Positive Impact Scale, and appearance concerns, body change concerns, life interferences, and worry subscales for the Negative Impact Scale. The IOCv2 also have three additional subscales measuring employment and relationship impacts. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). A higher score on a subscale/scale implies stronger endorsement of that content area.

Patients will complete the Cognitive Emotion Regulation Questionnaire (CERQ) (Jermann et al., 2006). The CERQ is a 36-item self-report measure of cognitive emotion regulation strategies someone uses after having experienced negative events or situations. The CERQ distinguishes 9 cognitive coping strategie: Self-blame, acceptance, rumination, positive refocusing, refocus on planning, positive reappraisal, putting into perspective, catastrophizing, and other-blame. Each item is scored from 1 ((almost) never) to 5 (always). The higher the score on a subscale, the more the patient uses this cognitive coping strategy.

Patients will complete the Multidimensional Fatigue Inventory (MFI-20) (Smets et al., 1995). The MFI-20 is a 20-item self-report measure of fatigue which covers the five following dimensions: General fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating greater fatigue.

Patients will complete a life event questionnaire assessing hours of physical activity practice, hours of sleep, drugs use, cafeine, theine and alcohol intake, psychogical background, and health care use.

Patients are provided with an armband (Garmin vívoactive® HR) to continuously record during nine days (two days of test and seven days of assessment), their heart rate levels, physical activity levels (pedometer and accelerometer) and sleep patterns.

The attentional dot probe computer task will provide a dynamic picture of patients' attentional orientation.

Jules Bordet Institute

Centre de Psycho-Oncologie (CPO)

Université Libre de Bruxelles

PhD, Professor

Symptoms and General Pathology

Inflammation

Caregiver Burden

Stress, Psychological

8 sessions of Emotion Regulation Therapy.

Emotion Regulation Therapy

Mia S O'Toole, MSc

Informal caregivers of cancer patients report high levels of psychological distress as evidenced in markedly increased levels of anxiety and depression. High levels of psychological distress in caregivers have also been found to be associated with poorer health and increased levels of pro-inflammatory cytokines that are well-established risk factors for physical illness and stress-related mortality. Previous psychological interventions using cognitive methods have only produced small effect sizes and more research on how to effectively alleviate caregiver burden is needed. The proposed project will investigate the effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel approach specifically targeting emotion regulation with the aim of improving mental and physical health. The effect of ERT will be examined in a randomized controlled trial comparing ERT to usual medical care (UMC).

PURPOSE:

The primary purpose of the study is to test the efficacy of Emotion Regulation Therapy (ERT) for informal caregivers (ICs) of cancer patients. ERT is a manualized treatment for ICs and consists of 8 weekly sessions.

AIMS AND HYPOTHESES:

Intervention and mediation effects. In an RCT, the investigators will investigate the efficacy of an 8 session ERT for ICs on psychological and physical distress and a number of other health outcomes in both ICs and cancer patients. Outcomes in the ERT group will be compared to outcomes in a group of ICs and patients receiving usual medical care (UMC) (see Figure 1). ICs receiving ERT compared to ICs receiving UMC are expected to exhibit 1a) significant reductions in psychological distress and perceived caregiving burden, 1b) improvements in quality of life; and 1c) improvements in pro-inflammatory markers of stress/immune functioning. Likewise, patients whose ICs receive ERT are expected to report 2a) reduced anxiety and depression, 2b) improved quality of life and 2c) less chronic inflammation. Due to the design, these effects will be considered following the acute treatment period (pre, mid and post therapy). In addition to this, gains are expected to be maintained over the follow-up-period. In addition, 3) improvements are exptected to be maintained over the follow-up period. Finally, 4) improvements in adaptive emotion regulation (mindfulness, acceptance, and cognitive reappraisal) are expected to mediate the effect of ERT.

PARTICIPANTS AND PROCEDURES:

ICs of cancer patients with various cancer types will be consecutively recruited from Aarhus University Hospital, Denmark. Staff at the Outpatient Clinic at the Department of Oncology, Aarhus University Hospital, Denmark, will screen ICs at the department. Initially the investigators wanted to include caregivers of patients with lung and colorectal cancer only. However, in order to be able to include caregivers at a faster pace, it was decided - after one month during which only two caregivers were included - to broaden the patient group. Furthermore, it was decided that more than one IC per patient could participate.

After giving informed consent, participants will be randomized to Emotion Regulation Therapy (ERT) or usual medical care (UMC) in a ratio of 1:1 by means of computer-generated randomization lists. Outcome measures will be obtained pre-, mid-, and post-therapy as well as at 3 and 6-month follow-up. At every ERT session, ICs and clinicians will fill out a number of self-report the process measures. Cancer patients will be assessed pre- and post ERT, and at 3 and 6-months follow-up. Every IC and patient will provide blood samples before and after the intervention as well as at follow-ups.

Based on a power calculation (alpha=0.0125, beta=0.90), a dropout rate of 35%, and an intraclass correlation between ICs of the same patient of 0.20, the inclusion of 80 ICs will allow for an interaction effect between group (ERT vs. UMC) and time (acute treatment, thats is, pre, mid and post) of a medium effect size (d=0.5) to be significant.

Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial

Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial

Questionnaire measuring burden in ICs and quality of life cancer patients, respectively

Questionnaire measuring anxiety and depression

Questionnaire measuring emotion regulation

Questionnaire measuring psychological distancing

Serum-derived pro-inflammatory markers (only pre and post therapy)

2 items (actual and wanted emotional closeness) rated on a 0-10 scale

University of Aarhus

Recurrence

Disease Attributes

ConquerFear-Group is a psychological intervention developed specifically for fear of cancer recurrence

The Relaxation Training serves as a placebo comparator and is not developed specifically to target fear of cancer recurrence.

The intervention consist of one 1½-hour individual session in which a psychologist will conduct an oral psychological assessment, and five 2-hour group sessions. The key goals of the intervention are to: a) teach strategies for controlling worry and excessive threat monitoring; b) modify underlying unhelpful beliefs about worry; c) develop appropriate monitoring and screening behaviors; d) educate about follow-up care and empirically-supported behavioral change (e.g., weight loss, exercise, etc.) to improve overall survival; e) address existential changes brought about by a cancer diagnosis; f) promote goal-setting. Each session is accompanied by home-based practice of skills learned in session and home reading to consolidate skill acquisition. Four trained psychologists (MSc) will perform the therapy. The intervention will be delivered on Zoom, a secure online platform.

ConquerFear-Group

The control group will receive one 1½-hour individual session and participate in five 2-hour group sessions. Patients will receive guided progressive muscle relaxation training. The intervention will be delivered on Zoom, a secure online platform.

Relaxation Training

Robert Zachariae, DMSc

The primary aim of this randomized controlled trial is to evaluate the effect of ConquerFear-Group (CF-G), compared with a control condition (CC), on Fear of Cancer Recurrence (FCR). Secondary aims are to explore the effect of CF-G on emotion regulation and additional psychological outcomes, and to explore mediating effects of emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion. In addition, treatment expectancy, participation in other treatments after completion of the intervention of the study and demographic and clinical variables will be explored as moderators.

A randomized controlled trial testing the efficacy of ConquerFear-Group (CF-G) on breast cancer survivors with clinical levels of Fear of Cancer Recurrence (FCR), compared with a control condition (CC), will be conducted.

The aims are to:

1. Evaluate the efficacy of CF-G on FCR,
2. Explore the effects on the secondary outcomes of emotion regulation, general distress, health-related QoL, survivors' unmet needs, mindfulness, metacognitions, intervention satisfaction, negative effects of intervention, and sleep.
3. Explore emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion will be explored as possible mediators.
4. Explore treatment expectancy, participation in other treatments after completion of the CF-G or the CC and demographic and clinical variables as possible moderators.

Primary hypothesis:

CF-G will yield larger reductions in FCR than CC at post treatment, and the effect will be maintained through the follow-up period.

Secondary hypotheses:

CF-G will demonstrate a larger improvement in measures of emotion regulation than CC following the intervention period.

Changes in emotion regulation during treatment will mediate the effect of CF-G on FCR.

Changes in metacognitions during treatment will mediate the effect of CF-G on FCR.

CF-G will yield larger reductions in general distress, health-related QoL, survivors' unmet needs than CC, and CF-G will yield larger improvements in metacognitions, mindfulness, and sleep than CC following the intervention period.

Participants are randomized in blocks of 16. Participants in each block will be randomly assigned in a 1:1 ratio to either CF-G or CC, resulting 2 x 8 groups of approx. 8 participants (min 5 and max 10 participants in each group). A computer-generated randomization list will be created by a person not directly involved in the intervention. Allocation to condition will take place after completion of the baseline questionnaire package

The investigator and assessor is masked in terms of not knowing to which condition the participants will be randomized until after completion of the baseline assessment. The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.

ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence

A Randomized Controlled Trial of ConquerFear: A Group-Based Psychological Intervention for Fear of Cancer Recurrence in Cancer Survivors

All data underlying publication will be shared in accordance with current data sharing regulations at host institutions.

Background information about the participants will be assessed with a questionnaire regarding demongraphic information as possible moderators

Clinical data will be explored as possible moderators

Treatment expectancy will be measured with the Credibility/Expectancy questionnaire as a possible moderator

Two questions regarding participation in other psychological, medical or complementary and alternative treatments for FCR after completion of the interventions of the present study will be assessed as a possible moderator

Changes in emotion regulation will be measured with the Brooding - Rumination and Reflection Scale

Changes in emotion regulation will be measured with the Penn State Worry Questionnaire

Changes in emotion regulation will be measured with the Experience Questionnaire

Changes in metacognitions will be measured with the Metacognitions Questionnaire-30

Changes in working alliance will be measured with the Working Alliance Inventory Revised Short Form

Changes in patient adherence will be assessed with a diary of home exercise completion

Changes in group cohesion will be assessed with the Therapeutic Factors Inventory Cohesiveness Scale

Single question to asses level of physical relaxation before and after each session

Single question to asses level of mental calmness before and after each session

Changes in fear of cancer recurrence will be measured with the 42-item Fear of Cancer Recurrence Inventory at baseline, 1 week post intervention, 3- and 6-months follow-up, and session-by-session with the 9-item Fear of Cancer Recurrence Inventory-Short Form

Changes in emotion regulation will be assessed with the Difficulties in Emotion Regulation Questionnaire

Changes in general distress will be measured with the Impact of Event Scale-Revised Questionnaire

Changes in general distress will be measured with the Depression, Anxiety, Stress Scale-21 Questionnaire

Changes in health-related quality-of-life will be measured with the European Organization for Research and Treatment of Cancer QLQ-C30 Questionnaire

Changes in health-related quality-of-life will be measured with EuroQol-5 Domain Questionnaire

Changes in survivors' unmet needs will be measured with the Survivors' Unmet Need Survey - 8 item Information Sub-Scale Questionnaire

Changes in fear of cancer recurrence will be measured with the Concerns About Recurrence Questionnaire

Changes in mindfulness will be measured with the Five Facet Mindfulness Questionnaire

Changes in sleep will be measured with the Insomnia Severity Index

Negative effects of the intervention will be assessed with one question about negative effects of the intervention experienced by the participants (narrative response)

Negative effects of the intervention will be measured with the Negative effects Questionnaire - hopelessness and failure subscales

Intervention satisfaction will be measured with three questions regarding satisfaction with the treatment

Aarhus University Hospital

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture before the random assignment to HRVB+DS arm. This group will receive a standardized HeartMath© Inner balance device and HRV biofeedback training session at the start of the two-week intervention period. They will be asked to attend either a group or one-on-one 30-minute HRVB training session and asked to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period. Participants will also be asked to watch four digital stories of other HCT patients (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each).

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture (REDCap) before the random assignment to HRVB waitlist +DS control arm. After the baseline data collection, during two weeks, they will be provided four digital stories of other HCT patients sharing their experiences (challenges, feelings, strategies, coping, each 2-3 minutes long). At the end of the two-week period, participants will be scheduled for a final in-person session including T2 survey and HRV assessment. They will be also provided HRVB training session at T2.

Baseline surveys contained a series of scaled questions, including sociodemographic variables (age, sex, cancer type, and etc), profile of mood states, social well-being, emotional processing and acceptance.

Baseline Surveys

Participants randomized to the intervention arm will receive exactly the same four digital stories via REDCap, a standardized HRV sensor and accompanying smart phone app, and a 30-minute HRVB training to use the biofeedback signals to generate a resonant frequency pattern of HRV (coherence) after collecting data at baseline in person. Participants will be given a take-home manual and specifically asked to practice their HRVB skills at home for 5 minutes prior to viewing stories once each week and upload a log of their time practiced to the cloud. The main purpose of adding HRVB practice as a "priming" experience (i.e., to teach participants to practice HRV prior to viewing stories) is to optimize results by focusing patients' and caregivers' skills and experience on HRV as a mechanism of improved emotion regulation, and then combine this achieved coherent pattern with DS intervention.

Heart rate variability biofeedback

Four Digital Stories Intervention (4 patient stories about hematopoietic cell transplantation (HCT) over the course of 2 weeks (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each). The 4 digital stories patients produced contained the following content: (1) a leukemia patient expressed and controlled her depression and anxiety and described how she dealt with the intensive treatment and recovery through a positive attitude and active coping; (2) a mother of 3 children, who was experiencing severe pain due to MS, coped with HCT through family support and positive reframing; (3) a lymphoma patient coped with the HCT procedures by praying during the treatment; and (4) a father of young twins had a HCT twice, and his wife helped him cope with emotional distress through open communication and expressing emotions.Participants will receive a 30-minute HRVB training session at T2.

Heart rate variability waitlist and Digital storytelling Control intervention

Sunny Kim, PhD

Patients undergoing hematopoietic stem cell transplantation (HCT) often continue to experience anxiety, depression, isolation, and other psychosocial distress due to the severe nature of the transplant experience. Storytelling interventions that provide an opportunity for emotional disclosure have shown preliminary efficacy to alleviate psychosocial distress and improve emotion regulation during health challenges. Not only are these changes observed in response to such interventions, but they can also be directly strengthened with HRV biofeedback (HRVB) training, a device-driven breath pacing practice that uses colored light signals to provide feedback to increase vagal tone and improve emotional responses and sleep quality by regulating negative affect and stress. This randomized controlled trial will explore the effects of HRV biofeedback (HRVB) training combined with a digital storytelling intervention and changes in psychosocial distress with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients.

This randomized controlled trial will explore the effects of an HRV biofeedback (HRVB) training session with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients. We will secondarily explore effects of a brief storytelling intervention, with or without the prior HRVB training. Two group of 10 HCT patients over the age of 18 will be recruited and enrolled into the study. The time of participating in this study will be 2-week proposed activities from the time of enrollment to completion. Specific participation will include baseline data collection (about 30 minutes), HRVB training session (30 minutes), watching and discussing stories (15 min for each week= 30 minutes) and one final data collection (about 30 minutes) at the end. For HRVB group, participants will be instructed to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period (about 140 minutes). Lab visit is required only twice for baseline data collection and final data collection. Other works will be via internet.

The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients

Depression will be measured using the Center for Epidemiological Studies Depression Scale Revised (CESD-R-10) scale (10 items, 4-point Likert scale (0 = rarely or none of the time, 3= all of the times, Cronbach's a = .86). The higher values represent a worse depression.

The Emwave Pro Plus device from HeartMath will be used to collect HRV data and heart rate using a 3-minutes "neutral" protocol (we call "waiting at the bus stop" implying that no particular intent for breath or mindful state is to be evoked) to understand the benefits of DS+ HRVB. In addition, HRV measures will be obtained for the 1-minute paced breathing period to understand the effects of paced breathing on HRV. The following precautions will be provided as instructions to participants prior to data collection: no coffee, tea, or caffeinated drinks such as energizing drinks in the 2 hours before the data collection, and no alcohol consumption during 24 hours prior to the data collection.

Psychological distress will be measured using the Profile of Mood States (POMS) short version (15 items, 5-point Likert scale; 0=not at all, 4=extremely). The POMS is one of the most frequently used and validated scales in studies of psychosocial interventions for cancer patients. The POMS Total Mood Disturbance (TMD) score has been shown to be most sensitive to interventions designed to facilitate emotional expression. The POMS consists of the TMD dimensions (tension-anxiety; depression-dejection; anger-hostility; and confusion-bewilderment) (Cronbach's a = .93) to be used in the current study as the primary outcome measure; and two others (fatigue-inertia; vigor-activity) will be documented. Total of Mood Disturbance= (anxious+depression+anger+fatigue)- vigor (Range from 12 to 48). The higher values represent a worse emotional well-being.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer	NCT02934815	Breast Neoplasm... Breast Cancer	Supportive-expr...	30 Years - 65 Years	Universidade do Porto
Improving Emotion Regulation at the End of Breast Cancer Treatment	NCT03336827	Breast Cancer Emotional Distu... Emotional Dysfu... Anxiety Depress... Fear of Cancer	Cognitive-Behav... Cognitive-Behav...	18 Years -	Université Libre de Bruxelles
Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial	NCT02322905	Anxiety Depress...	Emotion Regulat...	18 Years - 69 Years	University of Aarhus
ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence	NCT04137575	Fear of Cancer ... Breast Cancer F...	ConquerFear-Gro... Relaxation Trai...	18 Years -	Aarhus University Hospital
The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients	NCT04275830	Hematopoietic S... Bone Marrow Tra... Heart Rate Vari... Autonomic Nervo... Stress Mood Psychological D... Emotion Regulat... Communication R... Narrative	Baseline Survey... Heart rate vari... Heart rate vari...	18 Years -	Arizona State University

Spots Global Cancer Trial Database for emotion regulation