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

Université Libre de Bruxelles

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Behavioral: Cognitive-behavioral therapy and hypnosis group; Behavioral: Support group

Study type: Interventional

Funder types: Other

Identifiers

NCT01797354

Groupe support 22-007

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Cognitive-behavioral therapy and hypnosis group

Experimental group

Description:

Patients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis.

Treatment:

Behavioral: Cognitive-behavioral therapy and hypnosis group

Support group

Active Comparator group

Description:

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

Treatment:

Behavioral: Support group