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

NCT01797354 | Completed Phase 2 DMC

• 1 other identifier: Groupe support 22-007
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

patients at the end of treatment

Outcome Measures

Primary Outcomes (2)

• 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)

• 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.

Study Arms (2)

Cognitive-behavioral therapy and hypnosis group

EXPERIMENTAL

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

Support group

ACTIVE COMPARATOR

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

Behavioral: Support group

Interventions

Cognitive-behavioral therapy and hypnosis group BEHAVIORAL

Cognitive-behavioral therapy and hypnosis group

Support group BEHAVIORAL

Support group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No cognitive dysfunction
• No severe or uncontrolled psychiatric illness

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• Jules Bordet Institute: collaborator

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Related Publications (1)

• Merckaert I, Lewis F, Delevallez F, Herman S, Caillier M, Delvaux N, Libert Y, Lienard A, Nogaret JM, Ogez D, Scalliet P, Slachmuylder JL, Van Houtte P, Razavi D. Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: a randomized clinical trial comparing the benefits of single-component and multiple-component group interventions. Psychooncology. 2017 Aug;26(8):1147-1154. doi: 10.1002/pon.4294. Epub 2016 Nov 7.

  PMID: 27718533 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cognitive Behavioral Therapy; Self-Help Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Organizations; Health Care Economics and Organizations

Study Officials

• Darius Razavi, Prof

  Université Libre de Bruxelles, Institut Jules Bordet

  PRINCIPAL INVESTIGATOR

• Isabelle Merckaert, Prof

  Université Libre de Bruxelles, Institut Jules Bordet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, professor

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: February 22, 2013
• Study Start: July 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

BE (1)