To assess the effectiveness of mindfulness-based stress reduction (MBSR) for mood, breast- and endocrine-specific quality of life, and well-being after hospital treatment in women with stage 0 to III breast cancer.

A randomized, wait-listed, controlled trial was carried out in 229 women after surgery, chemotherapy, and radiotherapy for breast cancer. Patients were randomly assigned to the 8-week MBSR program or standard care. Profile of Mood States (POMS; primary outcome), Functional Assessment of Cancer Therapy–Breast (FACT-B), Functional Assessment of Cancer Therapy–Endocrine Symptoms (FACT-ES) scales and the WHO five-item well-being questionnaire (WHO-5) evaluated mood, quality of life, and well-being at weeks 0, 8, and 12. For each outcome measure, a repeated-measures analysis of variance model, which incorporated week 0 measurements as a covariate, was used to compare treatment groups at 8 and 12 weeks.

There were statistically significant improvements in outcome in the experimental group compared with control group at both 8 and 12 weeks (except as indicated) for POMS total mood disturbance (and its subscales of anxiety, depression [8 weeks only], anger [12 weeks only], vigor, fatigue, and confusion [8 weeks only]), FACT-B, FACT-ES, (and Functional Assessment of Cancer Therapy subscales of physical, social [8 weeks only], emotional, and functional well-being), and WHO-5.

MSBR improved mood, breast- and endocrine-related quality of life, and well-being more effectively than standard care in women with stage 0 to III breast cancer, and these results persisted at three months. To our knowledge, this study provided novel evidence that MBSR can help alleviate long-term emotional and physical adverse effects of medical treatments, including endocrine treatments. MBSR is recommended to support survivors of breast cancer.

Approximately 550,000 people are living with breast cancer in the United Kingdom.1 Surgery, chemotherapy, radiotherapy, and hormonal treatments for breast cancer have physical and psychological sequelae that last from months to years beyond hospitalization.24 Symptoms such as anxiety,5 depression,6 pain,7 fatigue,2 endocrine symptoms,8 and insomnia9 can reduce quality of life.

Psychoeducational support and integrative therapies for survivors, including the development of self-management skills to cope better, are unevenly provided worldwide. One increasingly popular approach to support people who are living with cancer is the cultivation of mindfulness.1012 Mindfulness (ie, bringing attention and awareness to each moment in a nonjudgemental way) is a way of being.13 Its origins are clearest in Buddhist philosophy, but elements of mindfulness are used in psychological approaches including cognitive-behavioral therapy. Mindfulness can be taught via a systematic 8-week mindfulness-based stress reduction (MBSR) program.13 The benefits of MBSR have been researched in long-term health conditions including chronic pain,1416 anxiety,17,18 fibromyalgia,19 psychological symptoms,20 psoriasis,21 increased stress and mood in outpatients with general cancer,10,11 and insomnia,1012 but methodological rigor was limited in all studies either as a result of problems, such as small sample sizes,1012 no randomization, or intention-to-treat analysis, or impeded by poor reporting. A review of 13 articles that evaluated mindfulness-based interventions and cancer since 200722 cited only one randomized controlled trial of MBSR and breast cancer.23 This randomized controlled trial of MBSR in stage 0 to III breast cancer (70% of participants had early stage 0 or I breast cancer) found improvements in fear of recurrence, depression, anxiety, physical functioning, physical role functioning, energy, and pain,23 but the sample size was small (N = 84), there was no follow-up period, and no correctional measures were applied for the large number of outcome measures used. Earlier MSBR in cancer and breast cancer studies showed improvements in mood including anxiety,10,11 stress,10,11 and sleep quality.12

To our knowledge, this study was unique from other MBSR and cancer studies. Participants were recruited from The London Haven, which is one of the day centers of the charity that provides free psychological and integrative therapies for patients with breast cancer. Participants received an average of 30 hours of Haven support before study entry.

A randomized controlled trial design was used to test the hypothesis that there would be a difference in the intervention group compared with controls as a consequence of being exposed to MBSR in mood, disease-related quality of life, including endocrine symptoms, and well-being for women with stage 0 to III breast cancer measured at baseline (T1; weeks −2 to 0), weeks 8 to 12 (T2), and weeks 12 to 14 (T3). An additional secondary study-specific analytic question was as follows: Is there a dose-related effect from doing formal mindfulness practice during the 8-week program?

Sample and Setting

Patients were recruited over 15 months from The Haven. Potentially eligible patients were contacted by letter and interviewed, and eligibility was strictly assessed by using the following inclusion criteria: women diagnosed with stage 0 to III breast cancer, aged between 18 and 80 years, who were aware of their cancer diagnosis, able to complete questionnaires, within 2 months to 2 years after the completion of surgery, chemotherapy, and/or radiotherapy. Patients excluded were diagnosed with stage IV breast cancer, men, did not speak English, could not give informed consent as a result of psychosis or intellectual impairment, or suffered from substance misuse, suicidal thoughts, or current psychosis. The study gained approval from the National Health Service's Local Research Ethics Committee.

After patients provided signed informed consent, participants were allocated to receive either MBSR or a wait-listed control. Random assignment was performed by operations director of the organization, who was independent from the study, by using an externally computer-generated randomization program in blocks of four, which ensured allocation concealment because no clinician/researcher could anticipate or direct the allocation of participants. The clinician-researcher conducting the study and delivering MBSR could not be blinded to the allocation of participants to either the treatment or control group. Anonymized data were collected by a research assistant who was blinded to group assignment and independent from MBSR delivery.

Sample Size

From related data,10 the sample-size calculation was based on a difference in primary outcome (Profile of Mood States [POMS] score) of 13 points with a standard deviation (SD) of 30. The use of results from nQuery Advisor Version 5 (Statistical Solutions Software, Saugus, MA) indicated that the recruitment of 85 participants per arm provided 80% power for a two-sided t test by using a 5% level of significance. To allow for dropouts and nonattendance, we planned to recruit 120 patients per arm for a total of 240 patients. Adjustment for T1 covariates was likely to increase the statistical power.

Intervention: Mindfulness-Based Stress Reduction

The 8-week MSBR program closely followed that of Kabat-Zinn13 and has been run in the United States for 30 years.24 The program aims to cultivate mindfulness, which is defined as bringing complete attention of the individual to the experience that occurs in the present moment in a nonjudgemental or accepting way.13,2528 Mindfulness can be practiced as a valuable self-help technique without requiring any belief system.

From a consensus within the literature,1013 a standardized MBSR program was divided into 8 weekly classes of 2 hours in length, except the first and last classes were 2.25 hours in length, plus one 6-hour day of mindfulness in week 6. The classes consisted of the following formal mindfulness practices: a body scan, gentle and appropriate lying and standing yoga-based stretches, sitting meditation, some group discussions, didactic teaching, and home practice on topics including perceptions of and reactions to life events, stress physiology, and mindfulness in communication and everyday life. Home practice was delivered by four 45-minute compact discs of formal mindfulness practices and a manual. Participants were asked to practice for 40 to 45 minutes for 6 or 7 d/wk. Time and the amount of formal home practice were recorded by using weekly record sheets. The clinician/researcher was qualified as an MBSR instructor at the University of Massachusetts Center for Mindfulness in 2004 and the Senior Teacher Trainer of the clinician/researcher provided clinical supervision during the study.

Between 2005 and 2006, a pilot feasibility 8-week MSBR group was run with 10 Haven staff and two women treated for breast cancer (who were not Haven attendees). The pilot was designed to give the instructor practice running the program under clinical supervision and to resolve any practical delivery problems. These data were not analyzed. After this pilot was run, 12 MBSR groups with 12 to 20 participants were run by the clinician-researcher. In the autumn of 2006, an additional MSBR group was run for the remaining wait-listed control group. Participants on the MBSR program with any study-related concerns could contact the clinician-researcher during or after the study period.

Wait-Listed Controls

Wait-listed controls continued with their lives as usual before participating in MSBR after the study period. Controls were offered measurement tools at T1, T2, and T3 while the experimental group had their MBSR program.

Outcome Measures

All outcome measures were completed at T1, T2, and T3. The primary outcome was mood and measured by using the POMS (65-item).29 The POMS total mood disturbance comprises subscales that evaluate anxiety, depression, anger, vigor, fatigue, and confusion. Lower scores indicated an improvement in mood.

Secondary outcomes included the following: Functional Assessment of Cancer Therapy-Breast (FACT-B) 37-item (Version 4) scale,30 which contains subscales of physical, social, emotional, and functional well-being in addition to the 10-item breast-specific subscale, which included concerns about body image, shortness of breath, and pain. The Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) scale, which contains the aforementioned subscales of physical, social, emotional, and functional well-being in addition to a 19-item endocrine-specific subscale that measures menopausal symptoms, including hot flashes, vaginal dryness, and loss of libido, and the WHO five-item well-being questionnaire (WHO-5).31,32 Higher scores in the Functional Assessment of Cancer Therapy and WHO-5 measures indicated an improvement in quality of life or well-being. All previously mentioned outcome measures were validated (J. Soulsby, personal communication, May 2003).29,30,3235

Data Analysis

The numbers of questionnaires analyzed from the treatment and control groups were 103 and 111 questionnaires, respectively. The numbers of questionnaires returned at T2 and T3 were 97 and 91 questionnaires, respectively, in the treatment group and 109 and 106 questionnaires, respectively, in the control group. The proration method (standard mean imputation) was used to address missing data within questionnaires as advised in the questionnaire manuals.33,36 When whole questionnaires were missing at T2 or T3, data were imputed by using previous values carried forward. There were three instances (two patients in the intervention group and one patient in the control group) in which more than 20% of data was missing from participants at T1, and thus, according to rules set by the questionnaire manuals, their data was excluded because it was too sparse to analyze. An intention-to-treat between-group analysis was performed because results of participants were analyzed in the groups to which they were randomly assigned. Data from the POMS and other scales were analyzed with a repeated-measures analysis of variance model by using SPSS version 18 software (SPSS, Chicago, IL). For each outcome variable, measurement occasions T2 and T3 formed the within-patients factor, the measurement made at T1 was used as a covariate, and treatment group was the between-patients factor. In this model, the between-patients factor indicated the treatment effect, and the interaction between the measurement occasion and treatment group indicated whether the treatment effect differed between T2 and T3. Treatment effects at T2 and T3 are presented as adjusted mean differences and 95% CIs. The clinical significance of results for Functional Assessment of Cancer Therapy scales and the WHO-5 are reported according to questionnaire-specific criteria (B. Brown, personal communication, February 2008).3739

To test whether hours of formal mindfulness practice done both in the classroom and at home were associated with improved outcomes at T2 and T3, a series of multiple linear regressions was done separately for each outcome at each time point. For each analysis, the measurement made at T1 was included as a covariate.

Sociodemographic and Clinical Characteristics

We recruited 229 women, and sociodemographic, clinical, and medical treatment details are listed in Table 1. The mean (SD) age was 49.0 years (9.26 years) in the experimental group and 50.1 years (9.14 years) in the control group. By using British socioeconomic status classifications, most participants were classified in the highest social class (73.7% of participants in the experimental group and 78.3% of participants in the control group). Two hundred fourteen women (93%), (mean age, 49 years) completed the study, which indicated a low dropout rate (the CONSORT diagram of the study is shown in Fig 1).

Table

Table 1. Sociodemographic and Clinical Characteristics of Sample at Baseline

Table 1. Sociodemographic and Clinical Characteristics of Sample at Baseline

Characteristic Experimental Group (n = 114)
Control Group (n = 115)
No. of Patients % No. of Patients %
Age, years
    Mean 49.0 50.1
    SD 9.26 9.14
Social grade
    AB: higher and intermediate managerial/administrative/professional 84 74 90 78
    C1: supervisory clerical junior managerial/administrative/professional 20 18 16 14
    C2: skilled manual workers 2 2 2 2
    D: semiskilled and unskilled manual workers 6 5 5 4
    E: on state benefits, unemployed, lowest-grade workers 2 2 2 2
Stage of breast cancer
    0 11 10 6 5
    I 34 30 45 39
    II 47 41 47 41
    III 22 20 17 15
Breast cancer is a recurrence 6 5 8 7
Surgery 113 99 115 100
Wide local excision/partial mastectomy, No. of operations
    Mean 0.75 0.93
    SD 1 1
    0 38 33 28 23
    1 67 59 67 59
    2 8 7 20 17
    ≥ 3 1 1 0 0
Mastectomy, No. of operations
    Mean 0.54 0.45
    SD 1 1
    0 57 50 68 59
    1 52 46 40 34
    2 5 4 5 4
Breast reconstruction, No. of operations
    Mean 0.36 0.30
    SD 1 1
    0 83 73 87 76
    1 24 21 22 19
    2 5 4 5 4
    3 1 1 1 1
    4 1 1 0 0
Chemotherapy 67 59 60 52
Neoadjuvant chemotherapy 20 18 8 7
No. of neoadjuvant cycles
    Mean 1.07 0.39
    SD 2 1
    Range 0-10 0-8
Adjuvant chemotherapy 54 47 56 49
No. of adjuvant cycles
    Mean 3.03 3.01
    SD 4 3
    Range 0-12 0-8
Radiotherapy 92 81 84 73
Endocrine treatment
    Yes 56 49 54 47
    Total 112 113
    Missing 2 2
Type of endocrine treatment frequency
    Anastrozole 15 13 13 11
    Goserelin 0 2 2
    Letrozole 3 3 0
    Tamoxifen 36 32 39 34
    Toremifene
    Not stated 1 1 0
    Not applicable 57 50 59 51
Second type of endocrine treatment
    Anastrozole 0 1 1
    Goserelin 5 4 2 2
    Megestrol acetate 0 0
    Tamoxifen 0 0
    Not applicable 107 94 110 96
Herceptin
    Yes 4 4 3 3
    Missing 2 2 1 1
Time between diagnosis of breast cancer and random assignment, months
    Mean 17.44 18.98
    SD 13 15
Time between completion of surgery,chemotherapy, and radiotherapy and random assignment, months
    Mean 9.27 9.50
    SD 6 6
No. of additional hours of Haven program attended
    Before T1
        Mean 30.09 31.48
        SD 17 14
    Between T1 and T2
        Mean 0.97 0.68
        SD 2 1
    Between T2 and T3
        Mean 0.59 0.32
        SD 2 1

Abbreviations: SD, standard deviation; T1, baseline (weeks −2 to 0); T2, weeks 8 to 12; T3, weeks 12 to 14.

Quality-of-Life Measures

There were no significant between-group differences found at T1 for any of the scales.

Mood State

There were statistically significant differences between treatment groups for POMS total mood disturbance, anxiety, depression, anger, vigor, fatigue, and confusion (Table 2). The T1-adjusted mean differences and 95% CIs at T2 and T3 suggested statistically significant lower mood-state scores in the experimental group than in the control group at both measurement occasions except for depression (T2 only), anger (T3 only), and confusion (T2 only). There were no statistically significant interactions between treatment group and measurement occasion.

Table

Table 2. Primary Outcome for POMS Total Mood Disturbance and Subscales and Estimates of Treatment Effects

Table 2. Primary Outcome for POMS Total Mood Disturbance and Subscales and Estimates of Treatment Effects

Outcome Measure Experimental (n = 103)
Control (n = 111)
Difference Between Groups at T2 and T3 Adjusted for Baseline
Mean SD Mean SD Mean 95% CI
Total score
    T1 total mood disturbance 43.65 34.73 49.23 39.37 NA
    T2 total mood disturbance 30.02 31.60 48.08 39.89 −15.30 −23.75 to −6.86
    T3 total mood disturbance 29.83 34.19 45.47 35.67 −12.91 −21.02 to −4.81
    Interaction time × treatment group, P 558
    Treatment group main effect, P < .001
Subscales
    T1 tension/anxiety 13.16 7.20 13.42 7.24NA
    T2 tension/anxiety 10.32 7.0 13.36 7.20 −2.93 −4.67 to −1.20
    T3 tension/anxiety 10.33 7.02 12.73 6.59 −2.30 −3.96 to −0.63
    Interaction time × treatment group, P .493
    Treatment group main effect, P < .001
    T1 depression/dejection 12.79 10.76 15.70 12.79NA
    T2 depression/dejection 10.0 9.95 14.96 13.23 −3.39 −6.06 to −0.71
    T3 depression/dejection 10.34 10.32 14.10 11.60 −2.32 −4.86 to 0.22
    Interaction time × treatment group, P .365
    Treatment group main effect, P .017
    T1 anger/hostility 10.75 8.08 11.60 8.62NA
    T2 anger/hostility 8.78 7.57 11.11 8.88 −1.96 −3.96 to 0.05
    T3 anger/hostility 7.87 6.72 11.04 8.95 −2.69 −4.44 to −0.95
    Interaction time × treatment group, P .458
    Treatment group main effect, P .005
    T1 vigor/activity −14.31 6.53 −14.06 6.19NA
    T2 vigor/activity −15.91 6.0 −13.57 6.61 −2.21 −3.67 to −0.75
    T3 vigor/activity −16.23 6.63 −13.47 6.22 −2.63 −4.12 to −1.15
    Interaction time × treatment group, P .606
    Treatment group main effect, P < .001
    T1 fatigue/inertia 11.17 6.64 11.75 7.20NA
    T2 fatigue/inertia 8.71 6.10 11.62 7.16 −2.68 −4.31 to −1.04
    T3 fatigue/inertia 9.27 6.90 11.39 6.73 −1.84 −3.45 to −0.22
    Interaction time × treatment group, P .324
    Treatment group main effect, P .002
    T1 confusion/bewilderment 10.11 5.58 10.65 5.57NA
    T2 confusion/bewilderment 8.13 4.71 10.33 5.30 −1.91 −3.01 to −0.81
    T3 confusion/bewilderment 8.24 5.32 9.63 4.31 −1.09 −2.20 to 0.01
    Interaction time × treatment group, P .141
    Treatment group main effect, P .002

NOTE. For each outcome measure, repeated-measures ANOVA was used with time (T2 and T3) as the within-patients factor, treatment group as the between-patients factor, and baseline measure (T1) as a covariate. The group × time interaction tested the null hypothesis that differences between groups at T2 and T3 were identical. The group effect tested whether there were significant differences in T2 and T3 between groups (ie, did the intervention have an impact?). Mean differences were used to compare groups at T2 and T3 after adjustment for values at T1 as a covariate.

Abbreviations: NA, not applicable; POMS, Profile of Mood States; SD, standard deviation; T1, baseline (weeks −2 to 0); T2, weeks 8 to 12; T3, weeks 12 to 14.

No established methods for calculating levels of clinical significance exist for POMS, and thus, this calculation was not undertaken (B. Brown, personal communication, February 2008).

Secondary Outcomes
Disease-related quality-of-life and endocrine symptoms.

Results for quality of life were measured by using the breast-specific quality-of-life scale FACT-B and the FACT-ES scale for endocrine symptoms. Higher numbers indicated better scores on all FACT scales.

After adjustment for the outcome measurement made at T1, there were statistically significant treatment effects for FACT-ES, FACT-B, physical well-being, social well-being, emotional well-being, and functional well-being (Table 3). Mean scores in the experimental group compared with the control group were greater at both T2 and T3 for all six measures (except social well-being which was significant at T2 only). For emotional well-being, there was some evidence that treatment effects at T3 were statistically significantly greater that at T2. No other interactions were statistically significant.

Table

Table 3. Secondary Outcomes for FACT-B, FACT-ES, WHO-5, and Estimates of Treatment Effects

Table 3. Secondary Outcomes for FACT-B, FACT-ES, WHO-5, and Estimates of Treatment Effects

Outcome Measure Experimental Group (n = 103)
Control Group (n = 111)
Difference Between Groups at T2 and T3 Adjusted for Baseline
No. of Patients Mean SD % No. of Patients Mean SD % Mean 95% CI
FACT-ES
    T1 102 127.02 18.84 107 127.08 23.20 NA
    T2 102 134.97 19.26 107 127.37 23.58 7.65 3.95 to 11.36
    T3 102 135.34 19.54 107 127.42 21.26 7.98 4.46 to 11.49
    Interaction time × treatment group, P .814
    Treatment group main effect, P < .001
FACT-B
    T1 101 96.57 17.22 106 96.68 21.05 NA
    T2 101 103.56 17.91 106 96.84 21.14 6.81 3.48 to 10.14
    T3 101 103.78 17.85 106 96.22 19.43 7.65 4.61 to 10.68
    Interaction time × treatment group, P .493
    Treatment group main effect, P < .001
FACT PWB
    T1 102 21.88 4.29 111 21.89 4.35 NA
    T2 102 22.86 4.22 111 21.84 4.54 1.03 0.19 to 1.87
    T3 102 22.97 4.34 111 21.67 4.87 1.31 0.49 to 2.12
    Interaction time × treatment group, P .521
    Treatment group main effect, P .002
FACT SWB
    T1 102 17.59 5.91 109 18.78 6.01 NA
    T2 102 18.36 5.65 109 18.26 5.88 1.06 0.17 to 1.94
    T3 102 18.09 5.81 109 18.30 5.75 0.71 −0.24 to 1.65
    Interaction time × treatment group, P .436
    Treatment group main effect, P .032
FACT EWB
    T1 102 16.91 3.84 109 15.97 4.58 NA
    T2 102 18.14 3.82 109 16.59 4.40 0.93 0.09 to 1.78
    T3 102 18.59 3.75 109 16.28 4.42 1.72 0.86 to 2.57
    Interaction time × treatment group, P .042
    Treatment group main effect, P .001
FACT FWB
    T1 102 17.83 5.03 110 17.65 5.83 NA
    T2 102 19.46 5.27 110 17.41 6.06 1.91 0.87 to 2.95
    T3 102 19.45 5.32 110 17.53 5.37 1.80 0.77 to 2.83
    Interaction time × treatment group, P .804
    Treatment group main effect, P < .001
WHO-5
    T1 103 13.04 4.48 52.2 111 12.53 4.68 50.1NA
    T2 103 14.91 4.23 59.6 111 12.60 4.92 50.4 2.01 1.00 to 3.01
    T3 103 15.08 4.62 60.3 111 12.65 4.30 50.6 2.15 1.16 to 3.15
    Interaction time × treatment group, P .768
    Treatment group main effect, P < .001

NOTE. For each outcome measure, repeated-measures ANOVA was used with time (T2 and T3) as the within-patients factor, treatment group as the between-patients factor, and baseline measure (T1) as a covariate. The group × time interaction tested the null hypothesis that differences between groups at T2 and T3 were identical. The group effect tested whether there were significant differences in T2 and T3 between groups (ie, Did the intervention have an impact?). Mean differences were used to compare groups at T2 and T3 after adjustment for values at T1 as a covariate.

Abbreviations: EWB, emotional well-being subscale; FACT, Functional Assessment of Cancer Therapy; FACT-B, Functional Assessment of Cancer Therapy–Breast; FACT-ES, Functional Assessment of Cancer Therapy–Endocrine Symptoms; FWB, functional well-being subscale; NA, not applicable; PWB, physical well-being subscale; SD, standard deviation; T1, baseline (weeks −2 to 0); T2, weeks 8 to 12; T3, weeks 12 to 14; SWB, social well-being subscale; WHO-5, WHO five-item well-being questionnaire.

The mean treatment effect was 7 for FACT-B at T2 and 8 for FACT-B at T3, which were the same as the minimum clinically important difference of 7 to 8 reported in the literature.37

Well-being.

After adjustment for T1 measurements, there were statistically significant increases in the WHO-5 in the experimental group compared with controls, and these were apparent at T2 and T3 (Table 3).

For the WHO-5, the minimum clinically important difference has been suggested to be a change of 10% on standardized percentage scores, which are obtained by multiplying the raw scores by four.37The adjusted mean differences, which are listed in Table 3 and expressed as standardized percentage scores, were 8.04% at T2 and 8.60% at T3. These scores were close to the minimum clinically important difference of 10%.

Dose-related effects of mindfulness.

The mean (SD) number of hours of formal home practice of mindfulness in the experimental group was 19.58 hours (11.49 hours) over 8 weeks, which equates to an average of 21 min/d. From their reports, participants changed their behavior and complied with home practice. When the mean classroom mindfulness practice time was added (average of 12 min/d over 8 weeks), 33 min/d of practice was undertaken. Attendance of MBSR classes in the experimental group was high with a mean (SD) of 17.45 hours (6.55 hours) over the course, averaging 2.18 h/wk. The mean (SD) number of weekly sessions attended (excluding the 6-hour day) was 6.26 sessions (2.12 sessions) of a possible eight sessions, which suggested participants were motivated.

Increased hours of formal mindfulness classroom and home practice in the experimental group was associated with improved scores in POMS total mood disturbance at T3 (P = .004), anxiety at T3 (P = .01), anger at T2 (P = .005) and T3 (P = .02), vigor at T3 (P = .02), fatigue at T3 (P = .03), and confusion at T2 (P = .04) and T3 (P = .001). These increased hours were also associated with improved scores in FACT-ES at T2 (P = .05) and T3 (P = .005), FACT-B at T3 (P = .006), FACT physical well-being at T3 (P = .04), and WHO-5 at T2 (P = .01) and T3 (P = .001). No serious adverse events were reported in this study.

To our knowledge, this study was the largest adequately powered trial to date that tested the effects of the MBSR program in women with stage 0 to III breast cancer. Important findings from this study included statistically significant improvements after MBSR compared with those of controls in overall mood, anxiety, depression, anger, vigor, fatigue and confusion, breast- and endocrine-related quality of life, emotional, physical, social, and role functional well-being, and general well-being. The improvement in mood reinforced and extended results found in other studies that evaluated mood in patients with cancer after MBSR10,11 and in patients with breast and prostate cancer.40 To our knowledge, our study is the first to show significant benefits of MBSR on mood in cancer at 3 months. Carlson et al11 measured follow-up in outpatients with cancer at 6 months, but positive changes were not maintained by that time point. Future research should include the measurement of longer-term follow-ups to determine the duration of the effects of the MBSR intervention.

Significant improvements in anxiety reinforced and extended findings from studies of anxiety and MBSR17,18 and anxiety in cancer10,23 and breast cancer.23 One explanation is that the process of becoming more aware of thoughts and feelings and relating to them as mental events from a decentered perspective, rather than as aspects of self or as true reflections of reality, can be applied to anxious and depressed thoughts.23 The finding that MBSR improves depression, anxiety, anger, confusion, fatigue, and vigor in patients with breast cancer extended findings from MBSR found in outpatients with general cancer.10 The improvements in depression was an important finding that added to the evidence base not only for MBSR for depression in breast cancer but also to the effectiveness of mindfulness for depression.41 The T1 total mood disturbance was worse than in earlier MBSR and general cancer studies10 and in cancer norms,42 perhaps because our sample had already identified themselves as needing help by coming to The Haven. The end of hospital treatment is known as a critical point for psychological problems4 and is a time when people are more likely to seek the help of MBSR at an integrative center like The Haven. A previous psychosocial supportive-expressive group-therapy intervention trial for patients with metastatic breast cancer showed beneficial effects only among patients who had more mood disturbance at T1.43 Therefore, it is possible that the enrollment of patients with stage 0 to III breast cancer with more mood disturbance in this study may have resulted in the positive effects observed.

To our knowledge, data of improvements in breast- and endocrine-specific quality of life from MSBR were novel as were the significant improvements in endocrine symptoms as measured by the FACT-ES scale. This is an important finding for women who take endocrine treatments for ≥ 5 years. Findings for improvements in overall well-being extended positive findings of MBCT44 in cancer (N = 25).

Participants showed a commitment to mindfulness practice by practicing 33 min/d, which compared well with 30 to 32 min/d in cancer (M. Speca, L.E. Carlson, personal communication, June 2008)10 and breast cancer,23 and all measurements were taken in the same way to include both classroom time and home practice combined. Most improvements were maintained, and some improvements were further improved at 4 weeks post-MBSR completion. Increased hours of formal mindfulness predicted significant improvements in mood disturbance, anxiety, anger, vigor, fatigue, confusion, endocrine- and breast-related quality of life, physical well-being, and general well-being. There was no other opportunity to learn meditation at The Haven during the study. Key limitations of this study included the following points: tensions of having a clinician-researcher role, although to reduce this bias, a research assistant handled data. After MBSR, during weeks 9 to 12 of the follow-up period, there was no record kept of the time spent practicing mindfulness. A self-report is a potentially biased measure, and cost effectiveness was not evaluated. The study setting was atypical of widely available support services. Generalizability was limited to women with stage 0 to III breast cancer who seek psychological services. Of note, patients less inclined to join this study included people with stage III disease and patients who received more chemotherapy and hormone therapy.

The importance of this study is that it demonstrated, within the boundaries of the limitations mentioned, statistically and clinically significant improvements in breast-related quality of life, including breast- and endocrine-specific symptoms, and general well-being. The results of this study support the recommendation for breast cancer survivors to use MBSR to enhance mood and quality of life including endocrine symptoms.

© 2012 by American Society of Clinical Oncology

Supported by the Girdlers' Company through the Florence Nightingale Foundation, Harvey White, MD, and The Haven.

Presented at the 8th Annual International Scientific Conference for Clinicians, Researchers and Educators, Centre for Mindfulness, University of Massachusetts, Worcester, MA, April 7-11, 2010, and the 1st British Breast Cancer Research Conference, University of Nottingham, Nottingham, United Kingdom, September 15-17, 2010.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

The author(s) indicated no potential conflicts of interest.

Conception and design: Caroline J. Hoffman, Steven J. Ersser,Jane B. Hopkinson

Collection and assembly of data: Caroline J. Hoffman, Steven J. Ersser, Jane B. Hopkinson, Peter G. Nicholls, Julia E. Harrington

Data analysis and interpretation: All authors

Manuscript writing: All authors

Final approval of manuscript: All authors

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Acknowledgment

We thank Julia Addington-Hall, PhD, Alex Molassiotis, PhD, Marie Polley, MD, The Haven; Harvey White, MD, the Florence Nightingale Foundation; and Florence Meleo Meyer, MS, MA.

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ARTICLE CITATION

DOI: 10.1200/JCO.2010.34.0331 Journal of Clinical Oncology 30, no. 12 (April 20, 2012) 1335-1342.

Published online March 19, 2012.

PMID: 22430268

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