Clinical trial NCT01797354: Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
Official title: Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: patients at the end of treatment
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
Collaborators: name: Jules Bordet Institute
First posted: 2013-02-22
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)
timeFrame: Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3)
measure: Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...
timeFrame: Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
affiliation: Université Libre de Bruxelles, Institut Jules Bordet
name: Darius Razavi, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Libre de Bruxelles, Institut Jules Bordet
name: Isabelle Merckaert, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.