Feasibility and Impact of Group Interventions on Breast Cancer Patients Well-being
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Yoga interventionBehavioral: Hypnosis interventionBehavioral: CBT intervention
- Registration Number
- NCT02569294
- Lead Sponsor
- University of Liege
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 114
- first breast cancer without metastases
- between 18 and 75-year-old
- ability to read, write and speak French.
- Patients with a diagnosed psychiatric disorder or dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Choice 1: Yoga intervention Yoga intervention See intervention description Choice 2: Hypnosis intervention Hypnosis intervention See intervention description Choice 3: CBT intervention CBT intervention See intervention description
- Primary Outcome Measures
Name Time Method Interest of patients in the three groups 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 %).
Reasons for choosing a particular group 3 years The second outcome is to determine the reasons for choosing a particular group (open question).
Reasons for declining to participate 3 years The third outcome is to determine the reasons for declining to participate to the groups (open question).
- Secondary Outcome Measures
Name Time Method Mental adjustment to cancer 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).
Emotional distress 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').
Quality of Life 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.
Quality of sleep 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).
Trial Locations
- Locations (1)
University Hospital of Liege
🇧🇪Liege, Belgium