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NCT Number: NCT01797354

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Institut Jules Bordet

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral therapy and hypnosis group

Behavioral

Support group

Behavioral

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Collaborators

  • Jules Bordet Institute

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 22, 2013
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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