NCT03336827 — Improving Emotion Regulation at the End of Breast Cancer Treatment · CancerIndex
Clinical trial · Interventional
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
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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)).
interventionNames
Behavioral: Cognitive-Behavioral Group Therapy and Hypnosis
type
OTHER
label
Waiting-List Control Group
description
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)).
interventionNames
Eligibility
Eligibility (as posted)
Sex
Female
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* Experiencing moderate to high emotion dysregulation (one to four scores = or \> 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts)
* Non-metastatic breast cancer
* Post chimiotherapy, radiotherapy, surgery treatment
* Age \> 18 years
* Completing a written informed consent
Exclusion Criteria:
* Male
* Non-fluency in French
* Severe cognitive impairment
* Severe and/or acute psychiatric disorder.
References
Publications (76)
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Behavioral: Cognitive-Behavioral Group Therapy and Hypnosis
Primary outcomes (6)
measure
Change in Patients' Subjective Emotion Regulation through six 10-cm visual analog scales assessing anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels
timeFrame
Change from T1 (baseline) Patients' Subjective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Patients' Subjective Emotion Regulation at T3 (4 months after T2) for the CG
description
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).
measure
Change in Patients' Objective Emotion Regulation through an ambulatory digital Holter recording heart rate (beats per minute)
timeFrame
Change from T1 (baseline) Patients' Objective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 monts after T2) for the EG; Change from T2 Patients' Objective Emotion Regulation at T3 (4 monts after T2) for the CG
description
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.
measure
Change in Patients' Emotion Regulation in their Everyday Life through an ecological momentary assessment
timeFrame
Change from T1 (baseline) Emotion Regulation in their Everyday Life at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Emotion Regulation in their Everyday Life at T3 (4 months after T2) for the CG
description
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).
measure
Change in Patients' Anxiety State through the Hospital Anxiety Depression Scale (HADS) - anxiety subscale and the Penn State Worry Questionnaire (PSWQ)
timeFrame
Change from T1 (baseline) Anxiety State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Anxiety State at T3 (4 months after T2) for the CG
description
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.
measure
Change in Patients' Depression State through the Hospital Anxiety Depression Scale (HADS)
timeFrame
Change from T1 (baseline) Depression State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Depression State at T3 (4 months after T2) for the CG
description
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.
measure
Change in Patients' Fear of Cancer Recurrence State through the Fear of Cancer Recurrence Inventory (FCRI)
timeFrame
Change from T1 (baseline) Fear of Cancer Recurrence State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Fear of Cancer Recurrence State at T3 (4 months after T2) for the CG
description
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.
Secondary outcomes (15)
measure
Change in an adapted Emotion Symptom Assessment Scale (ESAS)
timeFrame
Change from T1 (baseline) ESAS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ESAS at T3 (4 months after T2) for the CG
description
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).
measure
Change in the Hospital Anxiety and Depression Scale (HADS) Questionnaire
timeFrame
Change from T1 (baseline) HADS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 HADS at T3 (4 months after T2) for the CG
description
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.
measure
Change in the Fear of Cancer Recurrence Inventory (FCRI) Questionnaire
timeFrame
Change from T1 (baseline) FCRI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FCRI at T3 (4 months after T2) for the CG
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BACKGROUNDMorin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601. PMID 21532953
BACKGROUNDJermann, F., et al. (2006). Cognitive Emotion Regulation Questionnaire (CERQ): Confirmatory Factor Analysis and Psychometric Properties of the French Translation. European Journal of Psychological Assessment, 22, 126-131.
BACKGROUNDSmets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o. PMID 7636775
BACKGROUNDKillip S, Mahfoud Z, Pearce K. What is an intracluster correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004 May-Jun;2(3):204-8. doi: 10.1370/afm.141. PMID 15209195
DERIVEDMerckaert I, Waroquier P, Caillier M, Verkaeren O, Righes S, Lienard A, Libert Y, Kristanto P, Razavi D. Improving emotion regulation in breast cancer patients in the early survivorship period: Efficacy of a brief ecologically boosted group intervention. Psychooncology. 2023 Apr;32(4):597-609. doi: 10.1002/pon.6105. Epub 2023 Mar 8. PMID 36703250
description
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.
measure
Change in the White Bear Suppression Inventory (WBSI)
timeFrame
Change from T1 (baseline) WBSI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 WBSI at T3 (4 months after T2) for the CG
description
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.
measure
Change in the Mental Adjustment to Cancer Scale (MAC)
timeFrame
Change from T1 (baseline) MAC at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MAC at T3 (4 months after T2) for the CG
description
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).
measure
Change in Penn State Worry Questionnaire (PSWQ)
timeFrame
Change from T1 (baseline) PSWQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 PSWQ at T3 (4 months after T2) for the CG
description
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.
measure
Change in the Five Facet of Mindfulness Questionnaire (FFMQ)
timeFrame
Change from T1 (baseline) FFMQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FFMQ at T3 (4 months after T2) for the CG
description
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.
measure
Change in the Metacognitions About Health Anxiety Questionnaire (MCQ-30)
timeFrame
Change from T1 (baseline) MCQ-30 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MCQ-30 at T3 (4 months after T2) for the CG
description
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.
measure
Change in the Insomnia Severity Index (ISI)
timeFrame
Change from T1 (baseline) ISI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ISI at T3 (4 months after T2) for the CG
description
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.
measure
Change in the Impact of Cancer Scale (IOCv2)
timeFrame
Change from T1 (baseline) IOCv2 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 IOCv2 at T3 (4 months after T2) for the CG
description
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.
measure
Change in the Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame
Change from T1 (baseline) CERQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 CERQ at T3 (4 months after T2) for the CG
description
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.
measure
Change in the Multidimensional Fatigue Inventory (MFI-20)
timeFrame
Change from T1 (baseline) MFI-20 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MFI-20 at T3 (4 months after T2) for the CG
description
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.
measure
Change in a Life Event Questionnaire
timeFrame
Change from T1 (baseline) Life Event Questionnaire at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Life Event Questionnaire at T3 (4 months after T2) for the CG
description
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.
measure
Change in Ecological Momentary Assessment through the use of a pedometer and a measure of cardio frequency (Garmin vívoactive® HR)
timeFrame
Change from T1 (baseline) Heart Rate, Physical Activiy and Sleep Patterns at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Ecological Momentary Assessment at T3 (4 months after T2) for the CG
description
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.
measure
Change in Attentional Bias through a dot probe task
timeFrame
Change from T1 (baseline) Attentional Bias at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Attentional Bias at T3 (4 months after T2) for the CG
description
The attentional dot probe computer task will provide a dynamic picture of patients' attentional orientation.