Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment

Study Overview
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Brief Summary
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Background: The end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. Specific interventions adapted to this post-treatment period need thus to be designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. However, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. This study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation. Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. Patients will be assessed at three time points during the first year following the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment. Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks. Discussion: It is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. Results of this study will contribute to improving post-treatment care for breast cancer patients.

Official Title
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Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy and hypnosis group
* Behavioral: Support group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-metastatic breast cancer (in situ or invesive) End of active treatments (surgery, chemotherapy and radiotherapy) No recurrence nor palliative care Min. 18 years Able to speak French Willing to be randomized to study intervention group Accept to give their written informed consent Exclusion Criteria: No cognitive dysfunction No severe or uncontrolled psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioral therapy and hypnosis group<br>Patients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis. | Behavioral: Cognitive-behavioral therapy and hypnosis group<br> <br> |
| Active Comparator: Support group<br>Patients will receive (in groups of 6) fifteen 120-min support group session. | Behavioral: Support group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...) | Questionnaires: Quality of life questionnaires: EORTC QLQ-C30 and EORTC-BR23 Edmonton symptom evaluation scale Way of life questionnaire | Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3) | 
| Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,... | Questionnaires: the Hospital Anxiety and Depression Scale the Rosenberg's Self-Esteem the Mental Adjustment to Cancer Scale the Fear of Cancer Recurrence Inventory the Perceived Social Support Questionnaire the Courtauld Emotional Control scale the Ways of Coping Checklist the Toronto Alexithymia Scale a questionnaire about usual emotional state a questionnaire about the use of relaxation techniques and self-hypnosis | Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients at the end of treatment