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Running head: MBI FOR BREAST CANCER

Systematic Review of Literature: Mindfulness-Based Interventions for Breast Cancer Victoria L. Pringels & William E. Unger Touro University Nevada

MBI FOR BREAST CANCER Objectives The purpose of this systematic review is to determine if mindfulness-based interventions

(MBI) effectively reduce levels of stress and anxiety for individuals with breast cancer compared with traditional breast cancer treatment. The goal is to determine whether there are reliable objective measures in the literature regarding statistically significant efficacy for MBI for breast cancer. These findings would be significant to the field of occupational therapy by providing evidence for a non-pharmacological intervention to reduce the effect of stress and anxiety on occupational performance and engagement for women with breast cancer. Statement of Problem It is estimated in the United States during 2013, 232,340 new cases of breast cancer will emerge (Susan G. Komen for the Cure, 2013). Psychological symptoms of stress and anxiety are often comorbid conditions that women with breast cancer face. Psychological well-being is paramount to participation in everyday meaningful activities, and addressing stress and anxiety in clients with breast cancer falls well within the occupational therapy scope of practice. As of yet, formal payment for MBI is not reimbursed by insurance companies. The majority of MBI programs are funded through grants or out of pocket payments. As more evidence demonstrates the usefulness of this intervention, current and future occupational therapy students may benefit greatly from learning this technique. Furthermore, with future research in this area, occupational therapists will be able to determine which MBI are the most effective based on their targeted population. Background Literature An increased interest in MBI has instigated a wealth of research investigating the benefits of MBI on a variety of patient populations. The practice of mindfulness is rooted in Buddhist

MBI FOR BREAST CANCER traditions and focuses on building awareness of the present moment without judgment (Mace, 2008). Mindfulness uses a combination of meditation, breathing, and yoga techniques to center thoughts and feeling on the present moment. In a systematic review by Shennan, Payne, and

Fenlon (2011), the majority of MBI were mindfulness-based stress reduction (MBSR). However other interventions including mindfulness-based cognitive therapy (MBCT), psycho-educational studies, and mindfulness training were included in the review. MBSR is a specific type of MBI that provides a holistic framework for healing, allowing patients to explore their behaviors, thoughts, feelings, and bodily sensations (Baer, 2005). The MBSR program consists of eight weekly meetings, with an additional one-day retreat scheduled between week seven and week eight. Participants are also expected to practice at home for 45 minutes per day, six days per week. They are taught mind-body techniques including: body scan, breathing meditation, walking meditation, mindful movement, and psycho-education as part of the intervention. By becoming aware of the present moment, participants learn effective ways to handle various moods and emotions and also learn about healthy responses to stress. MBSR has shown statistically significant improvements in mental health for a variety of populations including cancer, chronic pain, arthritis, diabetes, organ transplants, psychiatric disorders, and stressed non-clinical populations (Zainal, Booth, & Huppert, 2013). Previous systematic reviews on MBSR for individuals with breast cancer were limited by small sample sizes, inclusion of breast cancer among other types of cancer populations, and inclusion of breast cancer survivors only. The most recent review of efficacy for MBSR with breast cancer survivors was a meta-analysis published by Zainal, Booth, and Huppert (2013). This study only included articles as recent as 2011. With the growth of interest in MBI, several more recent studies have been published since 2011 and thus this paper serves to investigate the most current

MBI FOR BREAST CANCER literature on the efficacy for MBI on stress and anxiety for women with breast cancer. It is important to also include women newly diagnosed with breast cancer, as well as breast cancer survivors. As the number of breast cancer diagnoses continues to increase, there are more newly diagnosed women living with stress and anxiety in regards to radiation, mastectomy, and chemotherapy concerns, and more survivors living with uncertainty of possible relapse, or additional treatments. Methods

Articles for this systematic review were located using online research databases available to students at Touro University, Nevada. The databases employed were Pub-Med, Cochrane Central Register of Controlled Trials, and Academic Search Complete. The search terms used to locate articles were combinations of the following: Mindfulness-Based Intervention, MBI, Mindfulness-Based Stress Reduction, MBSR, and Breast Cancer. Searches for the articles were conducted by the authors of this paper, however several of the included articles were recommended by the authors course instructor. Each of these articles met the same inclusion criteria as was applied to those found via internet databases. Inclusion criteria for articles required them to be randomized controlled trials (RCT), preposttest, or cohort studies. The population of selected studies had to be females of adult age with breast cancer. Interventions for selected studies could be any which employed mindfulness as their core feature. The sample size for selected studies had to be greater than 20 participants in order to help prevent the chances of type I or type II errors. Outcomes for selected articles had to include, but were not limited to, measures of anxiety and/or stress. Articles selected had to have been published within the past 10 years. All obtained articles were published in peer-reviewed

MBI FOR BREAST CANCER journals, and no grey-literature was used. All articles which did not meet these inclusion guidelines were rejected. Once articles were obtained, they were screened by the authors to ensure that they

employed sufficient design protocol to produce a reliable outcome. All articles included followed the proper methods of obtaining informed consent, and reported any potential biases which might have been present. Every article reported results in terms of statistical significance, and included necessary p values and charts to allow readers to corroborate the researchers findings. Once selected, the authors of this paper organized the articles according to level of evidence, MBI type, and population. The authors then critically reviewed each of the nine included articles, meeting weekly to compare and discuss findings. Results The nine studies reviewed included six randomized controlled trials and three preposttest designs. The studies were conducted in the United States, Canada, and Denmark. All participant samples were composed entirely of women, and sample sizes ranged from 27 to 336. All reported p values were < .05. Table 1 outlines the key components of each study, including objectives, study design, intervention and outcome measures, results, and study limitations. In a RCT by Lengacher et al. (2009), MBSR was evaluated for effectiveness in reducing stress, anxiety, depression, fear, sleep disturbances, fear of recurrence, and other disruptive symptoms amongst the population of breast cancer survivors. The intervention followed a six week MBSR course adapted for the specific circumstances of those who had faced breast cancer. The results found that participants assigned to the MBSR group had significantly lower (p < .05) adjusted mean levels of depression, anxiety, and fear of recurrence at six weeks, along with higher energy, physical functioning, and physical role functioning. Additionally, higher

MBI FOR BREAST CANCER compliance to the prescribed MBSR protocol demonstrated a trend towards greater improvements in energy and physical functioning. This study benefited the literature by examining the efficacy of MBSR in those who had survived breast cancer, demonstrating that

reduction in the severity of psychosocial symptoms was not limited to those currently battling the disease. Hoffman et al. (2012) conducted a RCT on 214 women with breast cancer to determine the effectiveness of MBSR compared to standard care for mood, quality of life, and well-being. This study composed of the third largest sample size, showed statistically significant improvements after MBSR for mood, anxiety, QOL, and well-being (p = .05). However, the participants were recruited from a breast cancer support center, The Haven. This study setting is atypical of widely available support services and limits the generalizability to women with breast cancer who seek psychological services. Wrtzen et al. (2012) conducted a RCT comparing the effectiveness of MBSR versus usual care in reducing anxiety and depression in 336 women with breast cancer. The intervention followed the original Kabat-Zinn MBSR protocol, with an additional five hour silent retreat after the seventh week. The study employed an immediate posttest, as well as additional six and 12 month follow up measurements. The researchers found that intention-to-treat analyses showed significant differences between groups in levels of anxiety (p =.0002) and depression (SCL-90r, p < .0001; CES-D, p < .0367) persisted at 12 months. Additionally, data indicated a significantly greater effect of the intervention among participants who had more anxiety and depression at baseline, compared with no differences for participants who scored in the lower quartile at baseline.

MBI FOR BREAST CANCER In a RCT by Carlson et al. (2013), mindfulness-based cancer recovery (MBCR) was compared to supportive expressive group therapy (SET) and a one-day stress management control group for distressed survivors of breast cancer. The MBCR intervention focused on

mindful meditation and yoga, while the SET intervention focused on expression of emotions and group support. The results indicated that the MBCR groups stress symptoms decreased more over time than the SET group (p = .009) and control group (p = .024). The limitations of this study include high dropout rates and no long-term follow up. However, this study substantially contributes to the literature as it provides the second largest sample size to date, with 271 survivors of breast cancer. Henderson et al. (2013) provided a RCT comparison of the effectiveness of MBSR to a nutrition education intervention (NEP) and usual care for 127 women with early-stage breast cancer. This study was noteworthy in that it used a large sample size, two control groups, and included follow-ups at one and two years post-intervention. Significant improvements after MBSR program were seen at 4 months (p = < .05) on 16 psychosocial factor outcomes. However, the results were no longer significant at the one year and two year follow-up. Monti et al. (2013) investigated the effectiveness of mindfulness-based art therapy (MBAT) vs. standard educational support on patients with breast cancer. MBAT is a specific type of MBI that was designed to enhance the MBSR curriculum. This intervention added expressive art tasks during the last 30 minutes of the MBSR program each week. This allowed participants to express thoughts and feelings that emerged during the mindfulness exercises in a creative manner. The results showed that MBAT provided statistically significant reductions (p < .01) in psychological stress and quality of life and that MBAT had longer lasting effect compared

MBI FOR BREAST CANCER to standard educational support. However, further research needs to be done to determine if MBAT is more effective than MBSR or group art therapy. Tacon, Caldera, and Ronaghan (2004) studied the effectiveness of MBSR on stress, anxiety, mental adjustment to cancer, and health locus of control in 27 women with breast

cancer. This pre- posttest reported significant decreases in stress (p <.001) and anxiety (p <.001). This study also included a unique element where participants were asked what components of the MBSR they enjoyed the most. Yoga and body scan were the top choices, providing clinicians with valuable information. While the effectiveness of yoga and body scan were not compared to the other portions of the MBSR program, this information can help guide clinicians into developing successful interventions utilizing MBSR components. In Tacons (2006) pre-posttest study, the effectiveness of MBSR in reducing state anxiety, depression, pain, and distress symptoms for women with breast cancer was examined. The intervention followed the original Kabat-Zinn MBSR protocol; single 1.5 hour sessions each week for eight weeks. Adaptations were made to the content of some of the sessions, such as applying MBSR techniques for use during radiation therapy. Results showed that participants displayed significant reductions (p < .05) in all outcome areas following the completion of the course. This study employed a small sample of 40 participants, and lacked a control group, but demonstrated the potential effectiveness of a community based MBSR program. Carlson, Speca, Faris, and Patel (2007) investigated effects of MBSR on quality of life, stress, mood and endocrine function in 49 women with early stage breast cancer. While this study only provides level III evidence, as it was a pre-posttest, the results indicate that the MBSR intervention was effective in decreasing symptoms of stress (p = .001) and improvements were maintained at the one year follow-up.

MBI FOR BREAST CANCER Narrative Synthesis Throughout the course of conducting this systematic review, a consistent trend of evidence supported the conclusion that mindfulness-based interventions are an effective form of complimentary treatment for women with breast cancer. Across the body of literature reviewed, four major themes were identified. First, MBI was found to be effective in reducing symptoms of stress and anxiety for breast cancer patients and survivors when compared to usual care. Many other variables were shown to have positive changes across the studies; such as depression, quality of life, and pain. As the focus of this systematic review, however, was to examine MBI on symptoms and stress and anxiety, the authors can conclude that the literature presents strong evidence for its effectiveness in addressing those variables. The deleterious effects of stress and anxiety on an individuals quality of life are well known, and MBI is a safe and client centered approach to addressing their influence. Second, minor adaptations to MBSR protocol to suit the specific experiences of breast cancer patients and survivors did not preclude the efficacy of the program. An example of such modification was teaching clients to use deep breathing techniques to reduce anxiety while receiving radiotherapy. This adaptability is important to note, particularly when striving to treat patients using a client-centered intervention. Not all individuals have identical histories, symptoms, or stressors which might contribute to their experiences of stress and anxiety. An individual with post-traumatic stress disorder, for example, may not share the same anxiety triggers as someone battling breast cancer. This being the case, the ability to slightly modify the MBSR protocol to suit the clients particular circumstances while still retaining significant

improvements in stress and anxiety is a strong testimonial for the use of MBSR in client-centered practice.

MBI FOR BREAST CANCER Third, individuals received benefit from MBI regardless of their stage of breast cancer.

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This is important to consider with respect to the clients continuum of care. While battling breast cancer may be considered a more frightening experience than recovering from breast cancer, the psychosocial needs of clients in recovery should not be neglected. Fear of recurrence, for example, is a unique phenomenon found in cancer survivors. The looming threat of having to face the illness more than once, as well as all the stressful experiences that come along with it, may have a persistent effect on an individuals quality of life regardless of how long their cancer has been in remission. By demonstrating that MBI were still effective in treating these harmful psychosocial symptoms regardless of stage of diagnosis, the literature validates the use of MBI as a therapeutic technique throughout full continuum of care. Fourth, individuals with higher baseline levels of stress demonstrated larger overall gains from the MBI programs. While at face value, this point may seem rather obvious, its importance in future research cannot be overstated. According to the evidence presented in the literature, if an individual begins their MBI with very low levels of stress and anxiety, one could expect to see very little change in terms of statistical significance. In other words, if their psychological state is already balanced, there is little to improve upon. In contrast, if an individual begins their MBI with a very high level of stress and anxiety, there is a large amount of room for improvement. When evaluating future research, the baseline scores for these psychosocial symptoms should be closely evaluated and compared with normative values of the general population. In this way, one might avoid the assumption that a MBI is ineffective, when in actuality the participants had a confounding variable of low baseline anxiety and stress which was not considered.

Running head: MBI FOR BREAST CANCER Table 1. Evidence Table


Author/ Year Lengacher et al. (2009) Study Objectives To determine the effectiveness of MBSR in reducing stress, anxiety, depression, fear, sleep disturbances, fear of recurrence, and other disruptive symptoms in breast cancer survivors Level/Design/Sub jects Level I RCT, preposttests 84 female breast cancer survivors Intervention and Outcome Measures Intervention: MBSR(BC) Outcome measures: Concerns about Recurrence Scale State-Trait Anxiety Inventory Center for Epidemiological Studies Depression Scale Life Orientation Test Perceived Stress Scale MOSS general Health Survey Medical Outcomes Social Support Survey Likert-scaled items assessing degree of spirituality, strength, and comfort derived from religion Intervention: MBSR Outcome Measures: Symptom Checklist-90-r Center for Epidemiological Studies - Depression

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Results MBSR(BC) had significantly lower adjusted mean levels of depression, anxiety, and fear of recurrence at 6 weeks (p < .05) Along with higher energy, physical functioning, and physical role functioning (p <. 05) Higher compliance to MBSR protocol demonstrated a trend towards greater improvements in physical functioning

Study Limitations Limited sample size Reliance on selfreported measures Potential cointervention from support group setting alone

Wrtzen et al. (2012)

To examine the effect of MBSR on levels of anxiety and depression amongst women with breast cancer

Level I RCT: preposttest measures, 6 and 12 month follow up measures 336 Danish women with breast cancer

Intention-to-treat analyses showed significant differences in anxiety (p = .0002) and depression (SCL90r, p < .0001; CES-D, p < .0367) at 12 months Individuals with higher baseline anxiety and depression experienced

Specific attributes of MBSR intervention were not evaluated for efficacy Level of adherence to MBSR postintervention could not be identified

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significantly greater gains Statistically significant improvements after MBSR was shown for mood, anxiety, QOL, and well-being (p = .05)

Hoffman et al. (2012)

Investigate effectiveness of MBSR in women with breast cancer for: Mood QOL Well-being

Level I evidence RCT 214 women with stage 0III breast cancer

Intervention: MBSR Measures: Profile of Mood States Functional Assessment of Cancer TherapyBreast & Endocrine WHO- 5

Monti et al. (2013)

Investigate effectiveness of MBAT vs. standard educational support on patients with breast cancer

Henderson et al. (2013)

Investigate the effectiveness of MBSR compared to NEP & UC in women with breast cancer

Carlson et el. (2013)

Investigate effectiveness of MBCR, SET, and a minimal treatment control for

Level I evidence RCT 191 women with breast cancer between 6 months and 3 years of original diagnosis Level I evidence RCT 172 women newly diagnosed early-stage breast cancer Level I evidence RCT 271 distressed women

Intervention: MBAT & Breast Cancer Support Group Measures: Symptoms Checklist Revised Medical Outcomes Study Short-Form Health Survey

MBAT showed statistically significant reductions in psychological stress and QOL (p <.01) MBAT has a longer lasting effect compared to standard educational support

Self-report Atypical study setting Only generalizable to women with stage 0-III breast cancer who seek psychological services Small sample size Unclear is MBAT is more effective than MBSR or group art therapy

Intervention: MBSR, NEP, & UC Measures: Beck Anxiety Inventory System Checklist 90Revised

Improvements after MBSR program were seen at 4 months (p = < .05) on 16 psychosocial factor outcomes

Demographics including mostly white, welleducated women

Intervention: MBCR, SET, and minimal treatment Measures: Profile of Mood States Calgary Symptoms of

MBCR is more effective in decreasing symptoms of stress in distressed women survivors of breast cancer compared to

High drop-out rates Lack of long-term follow up

MBI FOR BREAST CANCER


distressed survivors of breast cancer survivors of breast cancer Stress Inventory Functional Assessment of Cancer TherapyBreast Medical Outcomes of Study Social Support Survey

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SET (p = .009) and minimal treatment (p = .024)

Tacon et al. (2004)

Tacon (2006)

Investigate the effectiveness of MBSR for women with breast cancer on: Stress State anxiety Mental adjustment to cancer Health locus of control To assess the effectiveness of MBSR program on state anxiety, depression, pain and distress symptoms in women with breast cancer Investigate the effectiveness of MBSR for women with early stage breast on QOL

Level III evidence Pre-posttest 27 women diagnosed with breast cancer

Intervention: MBSR Measures: Current levels of stress Spielbergers state-trait measure

Significant reduction in stress (p <.001) Significant decrease observed in mean state anxiety scores (p <.001) Yoga and body scan were top choices of MBSR interventions

Small sample size No comparison group Self-selected volunteer participants Post-intervention data collected by program facilitators

Level III evidence Pre-posttest Cohort study 40 women with breast cancer

Carlson et al. (2007)

Level III evidence 1 year preposttest 49 patients with breast

Intervention: MBSR Outcome Measures: Spielbergers State Trait Measure of Anxiety Centre for Epidemiologic Studies Depression Scale McGill Pain Questionnaire Intervention: MBSR Measures: European organization for research and treatment of cancer quality of life

Researchers found significant reductions in state anxiety levels (p < .001), depression (p < .01), pain (p < .05), and distress (p < .01)

Small sample size Lack of a comparison group

8 wk MBSR program was effective in decreasing symptoms of stress (p < .001) Improvements were maintained at 1 year

No comparison group Results considered preliminary and hypothesis

MBI FOR BREAST CANCER


Stress Mood and endocrine Immune and autonomic parameters cancer questionnaire Profile of Mood States Symptoms of stress inventory

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follow-up generating Multiple statistical comparisons elevates the chances for type I and type II error Small sample size

Running head: MBI FOR BREAST CANCER Discussion

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This systematic review found evidence to support the use of MBI to decrease stress and anxiety for women with breast cancer. Studies analyzed in this review included women in all stages of breast cancer from the early stages of diagnosis to breast cancer survivors, MBSR interventions, MBAT interventions, and programs that used variations in the MBSR protocol. The majority of the participants were well-educated Caucasians, and attitudes towards the interventions may have contributed to the significant improvements in psychological well-being. This review is clinically significant, as it focuses on a very specific population and clearly demonstrates a pattern of MBI effectiveness for the breast cancer population. Another strength of this review is that it consists primarily of RCTs, which yield the highest level of evidence. Also, every study included was conducted within the past 10 years, providing readers with the most current evidence published. This review is limited in terms of generalization, as it is only applicable to women with breast cancer. It would be beneficial to include male breast cancer participants in future research. Another drawback to this systematic review is the fact that none of the included interventions were carried out by occupational therapists. We believe further research is warranted to determine which elements of the MBI protocols are the most effective. This will help occupational therapists determine the most practical way to incorporate MBI concepts into a variety of patient populations. We believe mindfulness should be an avenue for occupational therapists to explore due to the high rates of efficacy in the breast cancer population. It may be used as an effective preparatory method to increase patient performance in clients whose psychosocial impairments are limiting occupational engagement.

MBI FOR BREAST CANCER References

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Baer, R. A. (2005). Mindfulness-based treatment approaches: Clinicians guide to evidence base and applications. Burlington, MA: Academic Press. Carlson, L. E., Speca, M., Faris, P., & Patel, K. D. (2007). One year pre-post intervention followup of psychological, immune, endocrine and blood pressure outcomes of mindfulnessbased stress reduction (MBSR) in breast and prostate cancer outpatients. Brain, Behavior, and Immunity, 21(8), 1038-1049 doi: 10.1016/j.bbi.2007.04.002 Carlson, L. E., Doll, R., Stephen, J., Faris, P., Tamagawa, R., Drysdale, E., & Speca, M. (2013). Randomized controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy for distressed survivors of breast cancer. Journal of Clinical Oncology, 31(25), 3119- 3126. doi: 10.1200/JCO.2012.47.5210 Henderson, V. P., Massion, A. O., Clemow, L., Hurley, T. G., Druker, S., & Hebert, J. R. (2013). A randomized controlled trail of mindfulness-based stress reduction for women with early-stage breast cancer receiving radiotherapy. Integrative Cancer Therapies, 12(5), 404-413. doi: 10.1177/1534735412473640 Hoffman, C. J., Ersser, S. T., Hopkinson, J. B., Nicholls, P. G., Harrington, J. E., & Thomas, P. W. (2012). Effectiveness of mindfulness-based stress reduction in mood, breast- and endocrine- related quality of life, and well-being in stage 0 to III breast cancer: A randomized, controlled trial. Journal of Clinical Oncology, 30(12), 1335-1342. doi:10.1200/JCO.2010.34.0331 Lengacher, C. A., Johnson-Mallard, V., Post-White, J., Moscoso, M. S., Jacobsen, P. B., Klein, T. W., Kip, K. E. (2009). Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psycho-Oncology, 18, 1261-

MBI FOR BREAST CANCER 1279. doi:10.1002/pon.1529 Mace, C. (2008). Mindfulness and mental health: Therapy, theory and science. Florence, KY: Routledge. Shennan, C., Payne, S., & Fenlon, D. (2011). What is the evidence for the use of mindfulnessbased interventions in cancer care? A review. Psycho-Oncology, 20(7), 681-697. doi:10.1002/pon.1819 Susan G. Komen for the Cure. (2013). Breast cancer statistics. Retrieved from: http://ww5.komen.org/breastcancer/statistics.html Tacon, A. M., Caldera, Y. M., & Ronaghan, C. (2004). Mindfulness-based stress reduction in

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women with breast cancer. Family Systems & Health, 22(2), 193-203. doi:10/1037/10917527.22.2.193 Tacon, A. M. (2006). Mindfulness effects on symptoms of distress in women with cancer. Journal of Cancer Pain & Symptom Palliation, 2(2), 17-22. doi:10.1300/J427v02n02_03 Wurtzen, H., Dalton, S., Elsass, P., Sumbundu, A., Steding-Jensen, M., Karlsen, & Johansen, C. (2012). Mindfulness significantly reduces self-reported levels of anxiety and depression: Results of a randomized controlled trial among 336 Danish women treated for stage I-III breast cancer. European Journal of Cancer, 49, 1365-1373. doi:10.1016/j.ejca.2012.10.030 Zainal, N. Z., Booth, S., & Huppert, F. A. (2013). The efficacy of mindfulness-based stress reduction on mental health of breast cancer patients: A meta-analysis. Psycho-Oncology, 22, 1457-1465. doi:10.1002/pon.3171

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