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

September 3, 2015 updated by: Prof. Isabelle Merckaert, Université Libre de Bruxelles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Cognitive-behavioral therapy and hypnosis group
ACTIVE_COMPARATOR: Support group
Patients will receive (in groups of 6) fifteen 120-min support group session.
Behavioral: Support group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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,...
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
Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Libre de Bruxelles

Collaborators

Jules Bordet Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

December 28, 2011

First Submitted That Met QC Criteria

February 20, 2013

First Posted (ESTIMATE)

February 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Groupe support 22-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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