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Sponsor study identifier
interventional
260
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 28, 2011
Actual (reported)February 22, 2013
Actual (reported)September 2015
Actual (reported)September 2015
Actual (reported)Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)
Questionnaires: * Quality of life questionnaires: "EORTC QLQ-C30" and "EORTC-BR23" * Edmonton symptom evaluation scale * Way of life questionnaire
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: * 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
Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.
Patients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis.
Patients will receive (in groups of 6) fifteen 120-min support group session.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institut Jules Bordet
Brussels, 1000, Belgium
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.
Darius Razavi, Prof
Université Libre de Bruxelles, Institut Jules Bordet
Isabelle Merckaert, Prof
Université Libre de Bruxelles, Institut Jules Bordet
First Submitted
December 28, 2011
First Posted
February 22, 2013
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Contact the study team to confirm eligibility.
Study Completion
September 2015
Actual (reported)Last Updated
September 4, 2015
Record last verified: 2015-09
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Source: ClinicalTrials.gov.
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