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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797354
• Other study ID #: Groupe support 22-007
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2011
• Last updated: September 3, 2015
• Start date: July 2011
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Jules Bordet Institute
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Cognitive-behavioral therapy and hypnosis group

• Support group

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Université Libre de Bruxelles	Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)	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)	No
Primary	Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...	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.	No