Breast CancerPhase 2NCT01797354
Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
A Phase 2 study testing Cognitive-behavioral therapy and hypnosis group and Support group in people with Breast Cancer, run by Université Libre de Bruxelles at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive-behavioral therapy and hypnosis group and Support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2011to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No cognitive dysfunction
- No severe or uncontrolled psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cognitive-behavioral therapy and hypnosis group, Support group
- Keywords
- patients at the end of treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy and hypnosis groupBehavioural
Support groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive-behavioral therapy and hypnosis group |
| Support group | Active comparator | Patients will receive (in groups of 6) fifteen 120-min support group session. Receives: Behavioral: Support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJul 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Collaborators
- Jules Bordet Institute
- Responsible party
- Principal investigator, Prof. Isabelle Merckaert, Université Libre de Bruxelles
- Investigators
- Darius Razavi, Prof, Principal investigator, Université Libre de Bruxelles, Institut Jules BordetIsabelle Merckaert, Prof, Principal investigator, Université Libre de Bruxelles, Institut Jules Bordet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797354
- Sponsor's protocol ID
- Groupe support 22-007
- Status last verified
- Sep 2015
- First submitted
- 28 Dec 2011
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27718533
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
- ClinicalTrials.gov ID
- NCT01797354
- Acronym / sponsor ID
- Groupe support 22-007
- Conditions
- Breast Cancer
- Keywords
- patients at the end of treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Collaborators
- Jules Bordet Institute
- Study start
- Jul 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy and hypnosis group | Experimental | Behavioral: Cognitive-behavioral therapy and hypnosis groupPatients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis. |
| Support group | Active comparator | Behavioral: Support groupPatients will receive (in groups of 6) fifteen 120-min support group session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- No cognitive dysfunction
- No severe or uncontrolled psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapy and hypnosis group | Behavioural | Cognitive-behavioral therapy and hypnosis group |
| Support group | Behavioural | Support group |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Derived from this study: PubMed 27718533Merckaert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darius Razavi, Prof principal investigator
Université Libre de Bruxelles, Institut Jules Bordet
Isabelle Merckaert, Prof principal investigator
Université Libre de Bruxelles, Institut Jules Bordet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive-behavioral therapy and hypnosis group and Support group in people with Breast Cancer, run by Université Libre de Bruxelles at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.