Improving Emotion Regulation at the End of Breast Cancer Treatment

NCT03336827 | Completed

• 1 other identifier: Emotion Regulation
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 (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

Breast Cancer; Emotional Disturbances; Emotional Dysfunction; Anxiety Depression; Fear of Cancer

Keywords

Emotion Regulation; Post-Treatment Breast Cancer Care; Cognitive-Behavioral Therapy; CBT; Hypnosis

Outcome Measures

Primary Outcomes (6)

• 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

  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 from T1 (baseline) Patients' Subjective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Patients' Subjective Emotion Regulation at T3 (4 months after T2) for the CG

• Change in Patients' Objective Emotion Regulation through an ambulatory digital Holter recording heart rate (beats per minute)

  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 from T1 (baseline) Patients' Objective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 monts after T2) for the EG; Change from T2 Patients' Objective Emotion Regulation at T3 (4 monts after T2) for the CG

• Change in Patients' Emotion Regulation in their Everyday Life through an ecological momentary assessment

  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 from T1 (baseline) Emotion Regulation in their Everyday Life at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Emotion Regulation in their Everyday Life at T3 (4 months after T2) for the CG

• Change in Patients' Anxiety State through the Hospital Anxiety Depression Scale (HADS) - anxiety subscale and the Penn State Worry Questionnaire (PSWQ)

  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 from T1 (baseline) Anxiety State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Anxiety State at T3 (4 months after T2) for the CG

• Change in Patients' Depression State through the Hospital Anxiety Depression Scale (HADS)

  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 from T1 (baseline) Depression State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Depression State at T3 (4 months after T2) for the CG

• Change in Patients' Fear of Cancer Recurrence State through the Fear of Cancer Recurrence Inventory (FCRI)

  Change in patients' emotional state will be assessed in terms of fear of cancer recurrence: Fear of cancer recurrence is assessed by the Fear of Cancer Recurrence Inventory (FCRI). It is a 42-item 5-point ordinal self-report scale including seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance (Simard \& Savard, 2009). A higher score indicates higher levels of fear of cancer recurrence.

  Change 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

Secondary Outcomes (15)

• Change in an adapted Emotion Symptom Assessment Scale (ESAS)

  Change from T1 (baseline) ESAS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ESAS at T3 (4 months after T2) for the CG

• Change in the Hospital Anxiety and Depression Scale (HADS) Questionnaire

  Change from T1 (baseline) HADS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 HADS at T3 (4 months after T2) for the CG

• Change in the Fear of Cancer Recurrence Inventory (FCRI) Questionnaire

  Change from T1 (baseline) FCRI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FCRI at T3 (4 months after T2) for the CG

• Change in the White Bear Suppression Inventory (WBSI)

  Change from T1 (baseline) WBSI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 WBSI at T3 (4 months after T2) for the CG

• Change in the Mental Adjustment to Cancer Scale (MAC)

  Change from T1 (baseline) MAC at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MAC at T3 (4 months after T2) for the CG

Study Arms (2)

Experimental Group

OTHER

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)).

Behavioral: Cognitive-Behavioral Group Therapy and Hypnosis

Waiting-List Control Group

OTHER

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)).

Behavioral: Cognitive-Behavioral Group Therapy and Hypnosis

Interventions

Cognitive-Behavioral Group Therapy and Hypnosis BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Male
• Non-fluency in French
• Severe cognitive impairment
• Severe and/or acute psychiatric disorder.

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• Jules Bordet Institute: collaborator
• Centre de Psycho-Oncologie (CPO): collaborator

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

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MeSH Terms

Conditions

Breast Neoplasms; Affective Symptoms; Pathophobia; Emotional Regulation

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Darius Razavi, Prof

  Université Libre de Bruxelles, Institut Jules Bordet

  PRINCIPAL INVESTIGATOR

• Isabelle Merckaert, Prof

  Université Libre de Bruxelles, Institut Jules Bordet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: November 8, 2017
• Study Start: January 1, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)