Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
- Conditions
- Breast Cancer
- Registration Number
- NCT01797354
- Lead Sponsor
- Université Libre de Bruxelles
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 260
- 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
- No cognitive dysfunction
- No severe or uncontrolled psychiatric illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,... Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months. 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-hypnosisPhysical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...) Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3) Questionnaires:
* Quality of life questionnaires: "EORTC QLQ-C30" and "EORTC-BR23"
* Edmonton symptom evaluation scale
* Way of life questionnaire
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut Jules Bordet
🇧🇪Brussels, Belgium
Institut Jules Bordet🇧🇪Brussels, Belgium