- Mindfulness-based clinical interventions encompass multi-component mind-body modalities (mindfulness meditation, Yoga, psycho-education) aimed at reducing emotional distress, mood disturbances and fatigue and improving quality of life.
- Existing evidence suggests that mindfulness-based clinical interventions may improve psychosocial adjustment, especially concerning the reduction of anxiety and depression. Effects on physical health need to be evaluated in future research.
- While generally considered safe, the safety of mindfulness-based clinical interventions has not been rigorously assessed.
Mindfulness-based clinical interventions are mind-body modalities that may encompass multiple components: psycho-educational elements, mindfulness meditation exercises, cognitive-behavioral interventions and movement exercises. Core practices are: sitting meditation (breath awareness, focused attention), body scan (awareness of sensations in the body, 45 minute exercise), Hatha Yoga (mindful movement), walking meditation and insight meditation. The two most used mindfulness-based clinical interventions in oncology are: mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT).
Evidence can be drawn from the analysis of seven systematic reviews including 39 individual randomized controlled trials, six non-randomized controlled trials and 24 uncontrolled trials, as well as a further 10 RCTs published after these systematic reviews. One overview of systematic reviews and meta-analyses of RCTs is included as well.
An overall summary of results shows that the two most widely used mindfulness-based clinical interventions – mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) – have positive short-term and probably also medium-term effects on psychological function, in particular on anxiety and depression of breast cancer patients. Similar results are reported in the general cancer population but only a small number of trials are available. All reported effects are however small and prone to potential methodological bias. Evidence for MBSR and MBCT on physical health is lacking which prevents any conclusions to be drawn. Only for fatigue, some trials suggest effects of MBSR over and above those of usual care. For sleep problems, specialized cognitive-behavioral therapy for insomnia seems to be superior to MBSR.
While MBSR and MBCT are generally considered to be safe in supportive cancer care, no rigorous assessment of the safety of mindfulness-based approaches in cancer patients is available.
Summary fully revised and updated in August 2016 by Holger Cramer.
Updated in February 2016 by Ann-Christine Moenaert.
Summary first published in August 2012, authored by Ann-Christine Moenaert and Michaela Sieh.
Holger Cramer, Ann-Christine Moenaert, CAM-Cancer Consortium. Mindfulness [online document]. October 24, 2016.
Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) are multi-component mind-body modalities, encompassing psycho-educational elements, mindfulness meditation exercises, cognitive-behavioral interventions and movement exercises. Core practices are: sitting meditation (focused attention, breath awareness), body scan (awareness of sensations in the body, 45 minute exercise), Hatha Yoga (mindful movement), walking meditation and insight meditation. The founder of MBSR, Jon Kabat-Zinn, uses the following operational definition for mindfulness: “the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment by moment”1.
MBSR was first introduced as a clinical intervention for patients with chronic pain by Kabat-Zinn in 1979, in the Stress Reduction Clinic of the University of Massachusetts Medical Center. MBCT was developed by Zindel Segal, Mark Williams and John Teasdale, based on Jon Kabat-Zinn’s MBSR programme2.
The MBCT programme was designed specifically to help people who suffer repeated bouts of depression, and includes more psycho-educational elements than MBSR. MBCT also adds short formal meditation exercises to the program.
Application and dosage
The standard MBSR program (as developed by Kabat-Zinn delivered in groups of 6 to 30 patients) encompasses 8 weekly class sessions with a duration of 2 ½ to 3 ½ hours, plus an additional retreat day of six hours between weeks 6 and 7 of the program (20 to 35 ½ hours class time). Shortened versions for cancer patients have been tested in clinical trials3. A review on the relationship between class contact hours and effect sizes for psychological outcomes4 did not find any evidence that reduction of class hours might lead to decreased reduction of psychological distress4. Programs with fewer contact hours may be able to engage more cancer patients, because disease and treatment-related symptoms (including fatigue) sometimes present a barrier to take part in longer sessions.
In order to integrate mindfulness into everyday life, patients are usually asked to practice mindfulness exercises 45 minutes per day, 6 days per week during the program. A higher amount of home practice seems to increase self-reported mindfulness. It has been suggested that this may lead to improvements in psychological outcome4.
Some clinics provide day retreats and regular drop-in sessions for patients who completed the MBSR program5.
MBSR and MBCT are based on the ancient Buddhist practice and concept of mindfulness. Kabat-Zinn points out that mindfulness includes an “affectionate and compassionate quality within the attending and openhearted presence”1. The underlying ethical framework is built on the principles of non-harming. Kabat-Zinn notes the challenges posed to clinical implementation and research of mindfulness in the face of different epistemologies1.
A mindfulness teacher needs a foundation of personal practice (having experienced the radical transformational essence of mindfulness, as Kabat-Zinn states1 and is required to embody the core concepts of mindfulness.
There are adaptations and modifications of the original program manuals of MBSR and MBCT for cancer patients5-11.
Claims of efficacy/Alleged indications
MBSR and MBCT are implemented mind-body modalities in supportive cancer care. They are used in oncology settings because they have been suggested to have beneficial effects on various symptoms connected to cancer: emotional distress, mood, anxiety, depression, sleeping disorders, fatigue, quality of life6-19. Some studies point to a possible effect on immunological parameters3,20-22.
Mechanisms of action
Complex psycho-physiological connections and interactions are regarded as basic foundations of the effects of mind-body modalities23. Mindfulness meditation is assumed to promote regulation of emotions, this leads to a down regulation of the sympathetic nervous system and to a reduction of stress hormone levels24-26. Psycho-neuro-immunology research on the effect of mindfulness-based interventions on brain structure and functions and immunological status is in its infancy. Shapiro et al. point out that research on mindfulness requires a variety of methodological and theoretical approaches to develop testable hypotheses27.
Prevalence of use
A growing number of integrative oncology hospitals offer their patients mindfulness-based clinical interventions. Books on mindfulness for cancer patients have been published, leading to the use of mindfulness exercises as a self-help-technique. In 2012, 1.9% of the general US adult population had used mindfulness meditation (including MBSR and MBCT but also Buddhist mindfulness meditation). Among cancer survivors, 2.4%, 2.6%, and 1.8% of those with less than 1 year, between 1 and 5 years, and 5 or more years of survivorship, respectively, had used mindfulness meditation28.
Training for MBSR and MBCT teachers is not legally regulated, however, the University of Massachusetts Medical School’s Center for Mindfulness in Medicine, Health Care, and Society requires prospective teachers to meet the Qualifications and Recommended Guidelines for MBSR Teachers29. These include a 6-course educational pathway over 36 months30. While other MBSR/MBCT associations have adopted comparable educational guidelines, required training hours for certification vary depending on the organization providing the training. Practical experience in meditation (previous own meditation practice, attendance of teacher-led silent retreats) is under discussion, ranging from virtually no requirements to prerequisites of at least 2 years prior mediation practice and attendance of at least 2 five-day retreats.
Costs and expenditures
Fees for the 8 week-program (normally one weekly 2.5- to 3.5-hour class, often combined with a 6- to 7.5-hour full day retreat; a total of 20 to 35.5 class hours)29 of MBSR/MBCT range between € 200 and € 500, dependent on the setting. Partial or full reimbursement is available in some countries. Sometimes the programs are integrated into the general hospital services and are offered with reduced fees.
This summary is based on systematic reviews published in the last five years (since 2012) and subsequently published randomized controlled trials (RCTs). These publications indicate fast growing research efforts considering that the first RCT on the use of MBSR/MBCT in oncology dates from 2000. Details of the included studies are presented in table 1 for the systematic reviews and table 2 for the controlled clinical trials
Systematic reviews and meta-analyses
Four systematic reviews evaluate MBSR/MBCT in breast cancer patients and three in patients with various cancer diagnoses. There is some overlap in the systematic reviews in terms of the 39 individual RCTs, 6 non-randomized controlled trials, and 24 uncontrolled trials included (see table 1). The systematic review of systematic reviews by Gotink includes the systematic reviews by Piet et al35 and Cramer et al33.
The effect of mindfulness-based stress reduction (MBSR) has most commonly been investigated in female breast cancer patients. While most reviews would also have included mindfulness-based cognitive therapy (MBCT), no studies specifically on this intervention were located.
A common critique of these meta-analyses and systematic reviews is the lack of comparisons with other group-based psychosocial interventions not allowing for the identification of effects specifically attributed to specific mindfulness components rather than the attention and peer support associated with participation in psychosocial group based interventions35. In addition the focus of most reviews on breast cancer patients and thus limits the generalization of the results of these studies towards the global cancer patient population.
All systematic reviews on breast cancer mentioned methodological shortcomings of the included studies. Methodological shortcomings of the reviews themselves further limit the conclusions of the reviews. These include small numbers of included trials32-34, inadequate methodology for meta-analysis (ie, the use of mean differences for analyses of different outcome measures)32, and lack of safety assessment in all but one review33.
Randomized controlled trials
An additional 10 RCTs were located, which were published after the above-mentioned reviews38-47. For a description of included RCTs please see table 2. Four RCTs included breast cancer patients, another four mixed cancer populations and one lung cancer and prostate cancer, respectively.
Summary of effects by outcome
Effects of MBSR on depression
For breast cancer patients, the meta-analysis Cramer et al. (2012)33 reported small short-term effects of MBSR compared to usual care on depression. Comparable effects were found in the meta-analysis by Huang et al. (2015)32, however this analysis used inadequate methods which limit its conclusions. While the meta-analysis by Zainal et al. (2012)34 found moderate sized effects on depression, the magnitude of effects was reduced when only randomized trials were considered. The most recent meta-analysis by Zhang et al. (2016) 48 finally reported large effect sizes favoring MBSR over usual care.
With regards to the systematic reviews in mixed cancer populations, The meta-analysis by Piet et al. (2012)35 found small short- and longer-term effects of MBSR on depression for both, innergroup and within-group comparisons. Zhang et al. (2015)37 found large short-term effects and no medium-term effects favoring MBSR over usual care.
Effects of MBSR on anxiety
All four SRs in breast cancer patients assessed anxiety. Cramer et al. (2012)33 found moderate short-term effects of MBSR compared to usual care on anxiety. Again, the effects reported by Huang et al. (2015)32 are limited by the inadequate methodology used. Zainal et al. (2012)34 reported moderate sized effects on anxiety for uncontrolled pre-post comparisons, and small effects when only randomized trials were considered. Zhang et al. (2016)48 found small short-term effects of MBSR compared to usual care on anxiety, but moderate short-term effects on cancer-specific fear of recurrence.
For a mixed cancer population Piet et al. (2012)35 reported moderate short- and longer-term effects of MBSR on anxiety when only innergroup comparisons were considered. The effect sizes were small when only randomized trials were considered. In contrast, the more recent review by Zhang et al. (2015)37 found moderate short-term effects of MBSR on anxiety when compared to usual care, but no medium-term effects.
Effects of MBSR on stress
Three SRs including breast cancer patients assessed stress. Huang et al. (2015)32 reported short-term effects of MBSR on stress. Zainal et al. (2012)34 reported moderate effects on anxiety for uncontrolled pre-post comparisons, and small effects for randomized trials. The most recent meta-analysis by Zhang et al. (2016)48 found no effects of MBSR on stress in relation to usual care.
Stress was assessed in five of the subsequently published RCTs. Two RCTs reported positive effects of MBSR compared to supportive-expressive therapy40 or usual care47, while three found no group differences between MBSR and cognitive therapy39, a sleep hygiene intervention45, or usual care44.
Effects of MBSR on spirituality
Effects of MBSR on mindfulness
Based on the review by Piet et al. (2012)35 including patients with various cancers, MBSR has small short-term effects on mindfulness in both, uncontrolled trails and randomized group comparisons.
The three RCTs published after the systematic reviews report mixed results45-47.
Effects of MBSR or MBCT on other outcomes
For general distress, only one47 out of two RCTs found effects of MBSR47 or MBCT41 beyond usual care; two studies found no effects of MBSR beyond other psychological interventions39,40 reported positive effects of MBSR compared to usual care.
Health-related quality of lifewas measured in six RCTs; no group differences between MBSR and a sleep hygiene intervention occurred45; MBSR was superior to usual care in one out of four trials43,44,47; and MBCT was superior to usual care in two trials38,41.
Mindfulness-based clinical interventions are considered to be safe. Mindfulness-based clinical interventions are considered to be safe. However, the safety of meditation-based interventions in general has not been well-studied
Rare cases of adverse effects in people with underlying mental illnesses, including episodes of mania or depersonalization, have been reported49. There have been rare reports that meditation could cause or worsen symptoms in people who have certain psychiatric problems, but this question has not been fully researched50. Of the systematic reviews and studies analyzed for this summary, only one reported any safety-related data. Cramer et al. mention the lack of adequately reporting safety in the included studies; the only adverse events that could be extracted from the included trials were two cases of cancer recurrence in the MBSR groups. None of the remaining reviews planned to assess safety-related data. Likewise, none of the included trials which were not summarized in the included review reported on safety of the intervention.
None known. Individuals with existing mental or physical health conditions should speak with their health care providers prior to starting a meditative practice and make their meditation instructor aware of their condition50.
People with physical limitations may not be able to participate in certain meditative practices involving physical movement50.
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