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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Cognitive-behavioral therapy and hypnosis group; Behavioral: Support group

• 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

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-12-28
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-behavioral therapy and hypnosis group	Cognitive-behavioral therapy and hypnosis group	Patients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis.
Support group	Support group	Patients will receive (in groups of 6) fifteen 120-min support group session.

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-hypnosis
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

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium