Breast Cancer
Conditions
Keywords
patients at the end of treatment
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.
Interventions
BEHAVIORALCognitive-behavioral therapy and hypnosis group
BEHAVIORALSupport group
Sponsors
Jules Bordet Institute
Université Libre de Bruxelles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical 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 |
| 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-hypnosis |
Countries
Belgium
Outcome results
None listed