Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Université Libre de Bruxelles
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Prof. Isabelle Merckaert
PhD, professor
Université Libre de Bruxelles
Eligibility Criteria
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
Outcomes
Primary Outcomes
Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...
Time Frame: 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-hypnosis
Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)
Time Frame: 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