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| Name | Class |
|---|---|
| Jules Bordet Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-behavioral therapy and hypnosis group | Experimental | Patients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis. |
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| Support group | Active Comparator | Patients will receive (in groups of 6) fifteen 120-min support group session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy and hypnosis group | Behavioral |
| ||
| Support group |
| Measure | Description | Time Frame |
|---|---|---|
| Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...) | Questionnaires:
| 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:
| Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darius Razavi, Prof | Université Libre de Bruxelles, Institut Jules Bordet | Principal Investigator |
| Isabelle Merckaert, Prof | Université Libre de Bruxelles, Institut Jules Bordet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27718533 | Derived | Merckaert I, Lewis F, Delevallez F, Herman S, Caillier M, Delvaux N, Libert Y, Lienard A, Nogaret JM, Ogez D, Scalliet P, Slachmuylder JL, Van Houtte P, Razavi D. Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: a randomized clinical trial comparing the benefits of single-component and multiple-component group interventions. Psychooncology. 2017 Aug;26(8):1147-1154. doi: 10.1002/pon.4294. Epub 2016 Nov 7. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009938 | Organizations |
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| Behavioral |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D004472 |
| Health Care Economics and Organizations |