Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments yoga intervention, hypnosis intervention, cbt intervention
Sponsor University Hospital of Liege
Start date January 2013
End date March 2016
Trial size 114 participants
Trial identifier NCT02569294, Y-HYP-CBT-037

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 6-month follow-up).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
See intervention description
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)
See intervention description
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)
See intervention description
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.

Primary Outcomes

Measure
Interest of patients in the three groups
time frame: 3 years
Reasons for choosing a particular group
time frame: 3 years
Reasons for declining to participate
time frame: 3 years

Secondary Outcomes

Measure
Emotional distress
time frame: 4 years
Quality of Life
time frame: 4 years
Mental adjustment to cancer
time frame: 4 years
Quality of sleep
time frame: 4 years

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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

Additional Information

Official title Feasibility and Impact of Yoga, Self-hypnosis and Cognitive-behavioral Group Interventions in Improving Well-being of Breast Cancer Patients
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. 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 6-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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University Hospital of Liege.