Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03336827
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2017-08-04
Brief Title:
Improving Emotion Regulation at the End of Breast Cancer Treatment
Sponsor:
Université Libre de Bruxelles
Organization:
Université Libre de Bruxelles
Study Overview
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
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg hypnosis treatment of intrusive thoughts learning to cope with uncertainty attention reorientation toward positive thoughts to promote emotion management and well-being
Detailed Description:
1 Introduction
At the end of treatment breast cancer patients are confronted with the short- and long-term physical eg fatigue pain hot flashes and psychological eg anxiety fear of recurrence depressive symptoms consequences of cancer diagnosis and treatment Costanzo et al 2007 Stanton et al 2005 Emotion dysregulation eg anxiety fear of recurrence Devine Westlake1995 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 eg 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 hypnosisrelaxation 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 ie 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
41 Theoretical framework
This is a multi-component group intervention integrating an emotion regulation and an exposure to fear component
411 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
412 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 Borkovecs 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
42 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
421 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
422 Assessment procedure
Each assessment procedure ie 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
4221 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
4222 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 75 PM through the use of the software from httpwwwlifedatacorpcom 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
4223 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 eg intrusive thoughts misinterpretation behavioral eg body screening future planning difficulties emotional eg negative affects panic attacks and physiological status eg 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
At the end of treatment breast cancer patients are confronted with the short- and long-term physical eg fatigue pain hot flashes and psychological eg anxiety fear of recurrence depressive symptoms consequences of cancer diagnosis and treatment Costanzo et al 2007 Stanton et al 2005 Emotion dysregulation eg anxiety fear of recurrence Devine Westlake1995 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 eg 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 hypnosisrelaxation 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 ie 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
41 Theoretical framework
This is a multi-component group intervention integrating an emotion regulation and an exposure to fear component
411 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
412 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 Borkovecs 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
42 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
421 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
422 Assessment procedure
Each assessment procedure ie 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
4221 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
4222 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 75 PM through the use of the software from httpwwwlifedatacorpcom 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
4223 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 eg intrusive thoughts misinterpretation behavioral eg body screening future planning difficulties emotional eg negative affects panic attacks and physiological status eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None