Feasibility and Impact of Group Interventions on Breast Cancer Patients Well-being (GIBC)

July 11, 2017 updated by: Isabelle Bragard, University of Liege

Feasibility and Impact of Yoga, Self-hypnosis and Cognitive-behavioral Group Interventions in Improving Well-being of Breast Cancer Patients

This is a clinical non-randomized prospective study. This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer, at three times after the end of the interventions (just after the end, at a 3-month and at a 9-month follow-up).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (cognitive-behavioral therapy, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer.

Eligible breast cancer patients were identified through an institutional database or by referring physicians and were approached by phone to inform them of the intervention. They were given a choice between the three group interventions: CBT, yoga and self-hypnosis. Patients who agreed not to participate in any of the interventions were included in the control group. After giving written informed consent, patients completed a baseline assessment including self-reported measures. Follow-up assessment was conducted one week after the group intervention, and at a 3-month and 9-month follow-up. Interventions were proposed according to previous results showing the patient's interest in CBT, yoga and self-hypnosis, and the expertise of the team. Each intervention included 6 sessions of 1.5 hours.

The primary outcome measure was the interest in the three interventions (participation rate in each group). Since the study was first designed to determine interest, no sample size calculation was performed. Secondary outcomes were responses concerning emotional distress, QoL, sleep quality and mental adjustment to cancer assessed with self-reported questionnaires before and after the group interventions.

Descriptive statistics (percentages, means and standard deviation (SD)) were used to describe the proportions of patients who were interested in the group interventions and to examine their demographic, medical and psychological data. Baseline time 0 demographic, medical and psychological data were compared between groups to test for initial group equivalency using inferential statistics: analysis of variance (ANOVA) and Chi-square test, as appropriate. To be considered for the data analysis, patients had to attend at least three sessions. Multivariate analyses were calculated regarding group interventions and time of medical treatments (during or after chemo/radiation therapy). The pre- and post-assessment comparison of each measure within each group was made using the Wilcoxon test for matched pairs. All statistical tests were two-tailed, and a P-value <0.05 was considered statistically significant. Investigators also calculated Cohen's d effect size for each group. The analyses were performed with SPSS Version 21.0 (IBM Corp., Armonk, N.Y).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
      • Liege, Belgium, B-4000
        • University Hospital of Liege

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • first breast cancer without metastases
  • between 18 and 75-year-old
  • ability to read, write and speak French.

Exclusion Criteria:

  • Patients with a diagnosed psychiatric disorder or dementia

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Choice 1: Yoga intervention
See intervention description
Behavioral: Yoga intervention
Hatha-yoga intervention included 6 weekly 90-min sessions in groups of 3 to 8 participants led by Hatha-yoga trained teachers. This program was developed previously in Montreal and the following were included at each session: 1) preparatory warm-up synchronized with breathing; 2) selected postures (e.g. forward , backward-, and side-bending asanas in sitting and lying positions); 3) deep relaxation; 4) alternate-nostril breathing or pranayama; and 5) meditation. Each participant received a DVD to encourage at-home practice.
Experimental: Choice 2: Hypnosis intervention
See intervention description
Behavioral: Hypnosis intervention
Hypnosis intervention included 6 sessions of 2 hours every 2 weeks. This was led by an anesthesist with experience in oncology and trained in hypnosis. Based on years of consultation with cancer patients, her team created a negotiating approach that fosters shared decision-making through using tasks that are centered on general well-being rather than on the health problem itself. Patients were asked to be actively involved. Several topics are addressed through tasks: eg. adjusting self-expectations. Patients were also required to keep a work-diary that was reviewed at the beginning of each session. At the end of the session, a 15-min hypnosis exercise is conducted. They receive CDs containing the hypnosis exercises and homework assignments.
Experimental: Choice 3: CBT intervention
See intervention description
Behavioral: CBT intervention
CBT intervention included 6 weekly 90-min sessions in groups of 3 to 8 participants led by CBT-trained psychologists with experience in psycho-oncology. This program was developed by team leaders and is modelled on the work of Andersen et al. (2008) and Savard (2010). The intervention targets were: 1) breast cancer, meaning of illness, understanding stress and responses to it; 2) impact of treatment on body image; 3) impact of treatment on self-esteem; 4) fear of recurrence; 5) relationships with relatives and health professionals; and 6) life projects, return to daily activities and work. Relaxation training took place at the end of each session and participants performed tasks between sessions.
No Intervention: Control group
Participants who agreed not to participate in any of the interventions proposed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Interest of patients in the three groups
Time Frame: 3 years
The first outcome is to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate in each group (N and %).
3 years
Reasons for choosing a particular group
Time Frame: 3 years
The second outcome is to determine the reasons for choosing a particular group (open question).
3 years
Reasons for declining to participate
Time Frame: 3 years
The third outcome is to determine the reasons for declining to participate to the groups (open question).
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotional distress
Time Frame: 4 years
This outcome is measured with the Hospital Anxiety Depression Scale (HADS) at 4 time periods: before and just after the intervention, at a 3-month and a 9-month follow-up. The HADS is a reliable and validated 14-item measure assessing anxiety and depression in physically ill subjects [27]. Seven items for anxiety and 7 for depression are rated on a 4-point Likert scale (0=symptom not present to 3=symptom considerable). Each subscale is scored from 0 to 21 (0-7: 'normal range', 8-10: 'borderline', 11-21: 'probable presence of anxiety or depressive disorder').
4 years
Quality of Life
Time Frame: 4 years
This outcome is measured with European Organization for Research and Treatment of Cancer-Quality of Life Core Questionnaire-30 (EORTC-QLCQ30) and the Breast-cancer specific module (BR23) at 4 time periods: before and just after the intervention, at a 3-month and a 9-month follow-up.
4 years
Mental adjustment to cancer
Time Frame: 4 years
This outcome is measured with the Mental Adjustment to Cancer Scale (MAC) at 4 time periods: before and just after the intervention, at a 3-month and a 9-month follow-up. This is a 40-item questionnaire addressing reactions of patients on having cancer. Items are given as statements, and patients assess their agreement using a 4-point Likert-scale ('definitely does not apply to me' to 'definitely applies to me'). There are five subscales: Fighting Spirit (cut-off ≥47); Helplessness/Hopelessness (cut-off ≥11); Anxious Preoccupation (cut-off ≥25); Fatalism (cut-off ≥22) and Avoidance (cut-off ≥3); and two general subscales: Summary Positive Adjustment Scale (cut-off ≥47) and Summary Negative Adjustment Scale (cut-off ≥36).
4 years
Quality of sleep
Time Frame: 4 years
This outcome is measured with the Insomnia Severity Index (ISI) at 4 time periods: before and just after the intervention, at a 3-month and a 9-month follow-up. This is a 7-item measure of subjective sleep complaints and associated distress. Items are scored on a 5-point Likert scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The cut-off scores are 0-7 (no clinically significant sleep difficulties), 7-14 (sleep difficulties warrant further investigation) and 15+ (presence of clinically significant insomnia).
4 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Liege

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Guy Jerusalem, Prof., University of Liege

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Y-HYP-CBT-037

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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