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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive-behavioral therapy and hypnosis group

Intervention Type BEHAVIORAL

Support group

Patients will receive (in groups of 6) fifteen 120-min support group session.

Group Type ACTIVE_COMPARATOR

Support group

Intervention Type BEHAVIORAL

Interventions

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Cognitive-behavioral therapy and hypnosis group

Intervention Type BEHAVIORAL

Support group

Intervention Type BEHAVIORAL

Eligibility Criteria

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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