Feasibility and Impact of Group Interventions on Breast Cancer Patients Well-being
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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).
    

Intervention name(s): Yoga intervention; Hypnosis intervention; CBT intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: group interventions; emotional distress; breast cancer; yoga; hypnosis; cognitive-behavioral therapy