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The prevalence of sleep disturbance is high among cancer patients, and the sleep problems tend to last for years after the end of treatment. As part of a large randomized controlled clinical trial (the MICA trial, NCT00990977) of the effect of mindfulness-based stress reduction (MBSR) on psychological and somatic symptoms among breast cancer patients, the aim of the current study was to evaluate the effect of MBSR on the secondary outcome, 'sleep quality '. Material and methods. A total of 336 women operated on for breast cancer stage I-III 3-18 months previously were randomized to MBSR (n = 168) or treatment as usual (n = 168); both groups received standard clinical care. The intervention consisted of an eight-week MBSR program (psycho-education, meditation and gentle yoga). Sleep quality was assessed on the Medical Outcome Study sleep scale at baseline, after the intervention and at six-and 12-months ' follow-up. Results. The mean sleep problem scores were significantly lower in the MBSR group than in controls immediately after the intervention. Quantile regression analyses showed that the effect was statistically significant only for the participants represented by the lower percentile of change between baseline and post-intervention, i.e. those who had more sleep problems; the MBSR group had a significantly smaller increase in sleep problems than the control group. After the 12-month follow-up, there was no significant between-group effect of MBSR on sleep quality in intention-to-treat analyses. Conclusion. MBSR had a statistically significant effect on sleep quality just after the intervention but no long-term effect among breast cancer patients. Future trials in which participation is restricted to patients with significant sleep problems are recommended for evaluating the effect of MBSR on sleep quality.

The prevalence of sleep disturbance is high among cancer patients, and the sleep problems tend to last for years after the end of treatment. As part of a large randomized controlled clinical trial (the MICA trial, NCT00990977) of the effect of mindfulness-based stress reduction (MBSR) on psychological and somatic symptoms among breast cancer patients, the aim of the current study was to evaluate the effect of MBSR on the secondary outcome, 'sleep quality '. Material and methods. A total of 336 women operated on for breast cancer stage I-III 3-18 months previously were randomized to MBSR (n = 168) or treatment as usual (n = 168); both groups received standard clinical care. The intervention consisted of an eight-week MBSR program (psycho-education, meditation and gentle yoga). Sleep quality was assessed on the Medical Outcome Study sleep scale at baseline, after the intervention and at six-and 12-months ' follow-up. Results. The mean sleep problem scores were significantly lower in the MBSR group than in controls immediately after the intervention. Quantile regression analyses showed that the effect was statistically significant only for the participants represented by the lower percentile of change between baseline and post-intervention, i.e. those who had more sleep problems; the MBSR group had a significantly smaller increase in sleep problems than the control group. After the 12-month follow-up, there was no significant between-group effect of MBSR on sleep quality in intention-to-treat analyses. Conclusion. MBSR had a statistically significant effect on sleep quality just after the intervention but no long-term effect among breast cancer patients. Future trials in which participation is restricted to patients with significant sleep problems are recommended for evaluating the effect of MBSR on sleep quality.

INTRODUCTION:As the incidence of and survival from breast cancer continue to raise, interventions to reduce anxiety and depression before, during and after treatment are needed. Previous studies have reported positive effects of a structured 8-week group mindfulness-based stress reduction program (MBSR) among patients with cancer and other conditions. PURPOSE: To test the effect of such a programme on anxiety and depression among women with breast cancer in a population-based randomised controlled study. METHODS: A total of 336 women who had been operated on for breast cancer (stage I-III) were randomised to usual care or MBSR+usual care. Questionnaires including the Symptom Checklist-90r anxiety and depression subscales and the Center for Epidemiological Studies-Depression scale were administered before randomisation and immediately, 6 and 12 months after the intervention. RESULTS: Intention-to-treat analyses showed differences between groups in levels of anxiety (p=0.0002) and depression (SCL-90r, p<0.0001; CES-D, p=0.0367) after 12 months. Graphical comparisons of participants with higher levels of anxiety and depression at baseline showed a significantly greater decrease in the intervention group throughout follow-up and no differences among least affected participants. Medium-to-large effects were found for all outcomes in the intervention group in analyses of change scores after 12 months' follow-up. CONCLUSION: The 8-week group based MBSR intervention had clinically meaningful, statistically significant effects on depression and anxiety after 12 months' follow-up, and medium-to-large effect sizes. Our findings support the dissemination of MBSR among women with breast cancer.

BackgroundDiscussion regarding the necessity to identify patients with both the need and motivation for psychosocial intervention is ongoing. Evidence for an effect of mindfulness‐based interventions among cancer patients is based on few studies with no systematic enrollment. Methods We used Danish population‐based registries and clinical databases to determine differences in demographics, breast cancer and co‐morbidity among 1208 women eligible for a randomized controlled trial (www.clinicaltrials.gov identifier: NCT00990977) of mindfulness‐based stress reduction MBSR. Results Participants (N = 336) were found to be younger (p < 0.001) and have a less recent diagnosis at invitation than decliners (N = 872; p < 0.001). After adjustment for age and time since diagnosis at invitation, a statistically significant difference was also found between the two groups in use of psychologist sessions (p < 0.05), whereas neither breast cancer variables nor co‐morbidity was significantly different. Self‐reported data obtained by use of validated psychometric scales from 169 decliners and 336 women who agreed to enroll in the trial showed statistically significant differences in level of education, distress, anxiety, depression, well being and symptom burden. No differences were observed with regard to marital status, children living at home, affiliation to the work market, psychiatric caseness or any lifestyle measure. Conclusion Our findings indicate that participants are younger, have a less recent diagnosis and have a higher level of education than those who refuse. This should be taken into account in designing and evaluating trials of psychosocial interventions and in planning mindfulness‐based interventions.