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

NCT ID: NCT02569294

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-06-30

Brief Summary

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).

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Choice 1: Yoga intervention

See intervention description

Group Type: EXPERIMENTAL

Yoga intervention

Intervention Type: BEHAVIORAL

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.

Choice 2: Hypnosis intervention

See intervention description

Group Type: EXPERIMENTAL

Hypnosis intervention

Intervention Type: BEHAVIORAL

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.

Choice 3: CBT intervention

See intervention description

Group Type: EXPERIMENTAL

CBT intervention

Intervention Type: BEHAVIORAL

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.

Control group

Participants who agreed not to participate in any of the interventions proposed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Isabelle Bragard

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guy Jerusalem, Prof.

Role: STUDY_DIRECTOR

University of Liege

Locations

University Hospital of Liege

Liège, , Belgium

Countries

Belgium

References

Gregoire C, Nicolas H, Bragard I, Delevallez F, Merckaert I, Razavi D, Waltregny D, Faymonville ME, Vanhaudenhuyse A. Efficacy of a hypnosis-based intervention to improve well-being during cancer: a comparison between prostate and breast cancer patients. BMC Cancer. 2018 Jun 22;18(1):677. doi: 10.1186/s12885-018-4607-z.

Reference Type: DERIVED

PMID: 29929493 (View on PubMed)

Other Identifiers

Y-HYP-CBT-037

Identifier Type: -

Identifier Source: org_study_id