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Clinical Trials/NCT01797354
NCT01797354
Completed
Phase 2

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

Université Libre de Bruxelles1 site in 1 country260 target enrollmentJuly 2011
ConditionsBreast Cancer

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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