The efficacy of a mind-body-spirit group for women with breast cancer: a randomized controlled trial. Efficacy of prophylactic mastectomy in women with unilateral breast cancer: a cancer research network project. Contralateral prophylactic mastectomy improves the outcome of selected patients undergoing mastectomy for breast cancer. Impact of follow-up testing on survival and health-related quality of life in breast cancer patients. A multicenter randomized controlled trial. The GIVIO Investigators. Breast cancer screening with mammography: overview of Swedish randomised trials. A pilot phase II randomized, cross-over, double-blinded, controlled efficacy study of octreotide versus hyoscine hydrobromide for control of noisy breathing at the end-of-life. A randomized trial to increase physical activity in breast cancer survivors. Counseling women with breast cancer using principles developed by Albert Bandura. Randomized trial of breast self-examination in Shanghai: final results.
Increasing numbers of women with breast cancer are seeking alternatives to standard group support in coping with their illness. This study examines outcomes for 181 women with breast cancer randomized to either a 12-week standard group support or a 12-week complementary and alternative medicine (CAM) support intervention. Participants in the CAM group were taught the use of meditation, affirmation, imagery and ritual. The standard group combined cognitive-behavioral approaches with group sharing and support. Both interventions were found to be associated with improved quality of life (CAM, P=0.008; Standard, P=0.006), decreased depression (CAM, P=0.004; Standard, P=0.02), decreased anxiety (CAM, P=0.0003; Standard, P=0.02) and increased "spiritual well-being" (CAM, P=002; Standard, P=0.003). Only the CAM group showed increases in measures of Spiritual Integration (P=0.001) which were also significant between groups (P=0.003). The Standard group was associated with decreased confusion (P=0.01) and decreased helplessness/hopelessness (P=0.01), while the CAM group was associated with decreased avoidance (P=0.01). None of these latter changes were significant between groups. At baseline, very high correlations were noted between measures of quality of life, mood, and spiritual integration. At the end of the intervention, the CAM group showed higher satisfaction (P=0.006) and fewer dropouts (P=0.006) compared to the standard group. Better outcomes in quality of life in the CAM group were associated with lower initial fighting spirit (r=-.39, P=0.001). No baseline factors predicted better outcomes in the Standard group. In summary, the study found equivalence on most psychosocial outcomes between the two interventions. We investigated the efficacy of contralateral prophylactic mastectomy (CPM) in reducing contralateral breast cancer incidence and breast cancer mortality among women who have already been diagnosed with breast cancer.
                This retrospective cohort study comprised approximately 50,000 women who were diagnosed with unilateral breast cancer during 1979 to 1999. Using computerized data confirmed by chart review, we identified 1,072 women (1.9%) who had CPM. We obtained covariate information for these women and for a sample of 317 women who did not undergo CPM.
                The median time from initial breast cancer diagnosis to the end of follow-up was 5.7 years. Contralateral breast cancer developed in 0.5% of women with CPM, metastatic disease developed in 10.5%, and subsequent breast cancer developed in 12.4%; 8.1% died from breast cancer. Contralateral breast cancer developed in 2.7% of women without CPM, and 11.7% died of breast cancer. After adjustment for initial breast cancer characteristics, treatment, and breast cancer risk factors, the hazard ratio (HR) for the occurrence of contralateral breast cancer after CPM was 0.03 (95% CI, 0.006 to 0.13). After adjustment for breast cancer characteristics and treatment, the HRs for the relationship of CPM with death from breast cancer, with death from other causes, and with all-cause mortality were 0.57 (95% CI, 0.45 to 0.72), 0.78 (95% CI, 0.57 to 1.06), and 0.60 (95% CI, 0.50 to 0.72), respectively.
                CPM seems to protect against the development of contralateral breast cancer, and although women who underwent CPM had relatively low all-cause mortality, CPM also was associated with decreased breast cancer mortality. Risk factors for contralateral breast cancer (CBC) may indicate a benefit for contralateral prophylactic mastectomy (CPM) at the time of unilateral mastectomy for breast cancer. The purpose of this study is to evaluate the efficacy of CPM in preventing CBC.
                sixty-four patients undergoing CPM and a control group of 182 patients not undergoing CPM and matched for age, stage, surgery, chemotherapy, and hormonal therapy were retrospectively compared for CBC rate, disease-free survival, and overall survival.
                Thirty-six CBCs occurred in the control group. In the CPM group, 3 CBCs were found at the time of prophylactic mastectomy, but none occurred subsequently (P = 0.005). Disease-free survival at 15 years in the CPM group was 55% (95% confidence interval [CI] 38% to 69%) versus 28% (95% CI 19% to 36%) in the control group (P = 0.01). Overall survival at 15 years was 64% (95% CI 45% to 78%) CPM versus 48% (95% CI 39% to 58%) in controls (P = 0.26).
                CPM prevented CBC and significantly prolonged disease-free survival. Future studies will need to address risk assessment and contralateral breast cancer prevention in patients treated for early breast cancer. To assess prospectively the impact on survival and health-related quality of life of two follow-up protocols in patients with early breast cancer.
                Randomized controlled clinical trial.
                Multicenter study involving 26 general hospitals in Italy.
                A consecutive sample of 1320 women younger than 70 years with stage I, II, and III unilateral primary breast cancer.
                Patients were randomly assigned to an intensive surveillance, which included physician visits and performance of bone scan, liver echography, chest roentgenography, and laboratory tests at predefined intervals (n = 655), or to a control regimen (n = 665), in which patients were seen by their physicians at the same frequency but only clinically indicated tests were performed. Both groups received a yearly mammogram aimed at detecting contralateral breast cancer.
                Primary end points were overall survival and health-related quality of life.
                Compliance to the two follow-up protocols was more than 80%. At a median follow-up of 71 months, no difference was apparent in overall survival with 132 deaths (20%) in the intensive group and 122 deaths (18%) in the control group. No significant differences were apparent in time to detection of recurrence between the two groups. Measurements of health-related quality of life (ie, overall health and quality-of-life perception, emotional well-being, body image, social functioning, symptoms, and satisfaction with care) at 6, 12, 24, and 60 months of follow-up did not show differences by type of care received.
                Results of this trial support the view that a protocol of frequent laboratory tests and roentgenography after primary treatment for breast cancer does not improve survival or influence health-related quality of life. Routine use of these tests should be discouraged. Despite encouraging results from screening trials the efficacy of mammography in reducing mortality remains somewhat controversial. Five studies have been done in Sweden. This overview, based on 282,777 women followed for 5-13 years in randomised trials in Malmö, Kopparberg, Ostergötland, Stockholm, and Gothenburg, reveals a 24% (95% confidence interval 13-34%) significant reduction of breast cancer mortality among those invited to mammography screening compared with those not invited. To avoid the potential risk of differential misclassification causes of death were assessed by an independent end-point committee after a blinded review of all fatal breast cancer cases. The mortality reduction was similar, irrespective of the end-point used for evaluation ("breast cancer as underlying cause of death" or "breast cancer present at death"). There was a consistent risk reduction associated with screening in all studies, although the point estimate of the relative risk for all ages varied non-significantly between 0.68 and 0.84. The cumulative breast cancer mortality by time since randomisation was estimated at 1.3 per 1000 within 6 years in the invited group compared with 1.6 in the control group. The corresponding figures after 9 years are 2.6 and 3.3 and after 12 years 3.9 and 5.1. The largest reduction of breast cancer mortality (29%) was observed among women aged 50-69 at randomisation. Among women 40-49 there was a non-significant 13% reduction. In this younger age group cumulative breast cancer mortality was similar in the invited and control group during the first 8 years of follow-up. After 8 years there was a difference in favour of the invited women. There was no evidence of any detrimental effect of screening in terms of breast cancer mortality in any age group. Among women aged 70-74 years screening seems to have had only a marginal impact. Noisy breathing at the end of life (noisy breathing ("NB") occurs in up to 90% of people. Interventions have not been systematically evaluated. There has been clinical observation coupled with a proposed mechanism of effect that supports a role for octreotide in management of NB. The aim of this phase II study was to assess ten completed participants for the feasibility of an adequately powered phase III study. This randomized, double-blind, crossover pilot trial recruited participants from an inpatient palliative unit. Participants while well and their proxies simultaneously provided written informed consent. If NB were encountered, people were randomized to 200 mcg octreotide or 400 mcg hyoscine hydrobromide subcutaneously. If subsequent treatment was needed, the other medication was administered. A five point categorical scale documented the nurses' assessment of secretions over six hours. Eighty participants were consented of whom 10 (3 females, 7 males; median age 79, all with advanced cancer) received medication, five in each arm. There was no difference in the median time to administration of the second medication (3 hours). Two participants in each arm had a 2 category reduction of intensity after the second medication. Although feasible to consent and study this population in a way that respects autonomy and dignity even in the terminal hours of life, this pilot study suggests reconsideration of the pharmacological interventions (choice of agents, dosing, timing of dosing and pharmacokinetic profiles), standardizing of non-pharmacological care; and ways to measure directly family distress before further randomized studies for this symptom. Interventions to increase physical activity among breast cancer survivors are needed to improve health and quality of life and possibly to reduce the risk of disease recurrence and early mortality. Therefore, we report the feasibility and preliminary outcomes of a pilot randomized trial designed to increase physical activity in sedentary breast cancer survivors receiving hormone therapy.
                Forty-one sedentary women on estrogen receptor modulators or aromatase inhibitors for stage I, II, or IIIA breast cancer were randomly assigned to receive a 12-wk multidisciplinary physical activity behavior change intervention or usual care.
                Recruitment was 34%, intervention adherence was 99%, and complete follow-up data were obtained on 93%. Most participants (93%) were white with mean age of 53 +/- 9 yr. Differences favoring the intervention group were noted for accelerometer physical activity counts (mean difference = 72,103; 95% confidence interval (CI) = 25,383-119,000; effect size (d) = 1.02; P = 0.004), aerobic fitness (mean difference = 2.9; 95% CI = -0.1 to 5.8; d = 0.64; P = 0.058), back/leg muscle strength (mean difference = 12.3; 95% CI = 0.4-15.9; d = 0.81; P = 0.017), waist-to-hip ratio (mean difference = -0.05; 95% CI = -0.01 to -0.08; d = -0.77; P = 0.018), and social well-being (mean difference = 2.0; 95% CI = 0.3-3.8; d = 0.76; P = 0.03). However, the intervention group also reported a greater increase in joint stiffness (mean difference = 1.1; 95% CI = 0.1-2.2; d = 0.70; P = 0.04).
                A behavior change intervention for breast cancer survivors based on the social cognitive theory is feasible and results in potentially meaningful improvements in physical activity and selected health outcomes. Confirmation in a larger study is warranted. Although researchers suggest treatments that provide patients with an active coping strategy may increase patients' sense of self-efficacy, previous studies have not measured patients' self-efficacy.
                Eighteen women receiving chemotherapy for breast cancer were randomized to efficacy-enhancing experimental (n = 10) and usual-care control (n = 8) groups. The experimental group received five interventions delivered monthly. Variables--quality of life, symptom distress, and self-care self-efficacy--were measured at baseline and at 4 and 8 months later.
                At 4 and 8 months the interaction effects for the Functional Assessment of Cancer Treatment-Breast, used to measure quality of life, ranged from small for functional concerns to large for social concerns. Interaction effects for symptom distress, measured by the Symptom Distress Scale, were large. Interaction effects for self-care self-efficacy ranged from small for Enjoying Life and Stress Reduction, medium for Stress Reduction, and large for Making Decisions.
                Interventions to promote self-efficacy may increase quality of life and decrease distress for women diagnosed with breast cancer. Among women who practice breast self-examination (BSE), breast cancers may be detected when they are at an earlier stage and are smaller than in women who do not practice BSE. However, the efficacy of breast self-examination for decreasing breast cancer mortality is unproven. This study was conducted to determine whether an intensive program of BSE instruction will reduce the number of women dying of breast cancer.
                From October 1989 through October 1991, 266,064 women associated with 519 factories in Shanghai were randomly assigned to a BSE instruction group (132,979 women) or a control group (133,085 women). Initial instruction in BSE was followed by reinforcement sessions 1 and 3 years later, by BSE practice under medical supervision at least every 6 months for 5 years, and by ongoing reminders to practice BSE monthly. The women were followed through December 2000 for mortality from breast cancer. Cumulative risk ratios of dying from breast cancer were estimated using Cox proportional hazards models. All statistical tests were two-sided.
                There were 135 (0.10%) breast cancer deaths in the instruction group and 131 (0.10%) in the control group. The cumulative breast cancer mortality rates through 10 to 11 years of follow-up were similar (cumulative risk ratio for women in the instruction group relative to that in the control group = 1.04, 95% confidence interval = 0.82 to 1.33; P =.72). However, more benign breast lesions were diagnosed in the instruction group than in the control group.
                Intensive instruction in BSE did not reduce mortality from breast cancer. Programs to encourage BSE in the absence of mammography would be unlikely to reduce mortality from breast cancer. Women who choose to practice BSE should be informed that its efficacy is unproven and that it may increase their chances of having a benign breast biopsy.
Sixteen studies have been published since the last version of the review, without altering our conclusions. While published observational studies demonstrated that BPM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies (ideally randomized trials) are needed. BPM should be considered only among those at very high risk of disease. There is insufficient evidence that CPM improves survival and studies that control for multiple confounding variables are needed.