Mindfulness Using a Wearable Brain Sensing Device for Health Care Professionals During a Pandemic: A Pilot Program.

OBJECTIVE: The purpose of this feasibility pilot study was to evaluate safety and adherence of a wearable brain sensing wellness device designed to reduce stress among healthcare professionals (HCP). METHODS: A total of 40 HCP were invited to participate in an open-label pilot study. Participants were asked to use a brain sensing wearable device (MUSE-S™) on a daily basis to reduce their stress, for a total of 90 days. Total study participation duration was 180 days. Study enrollment began in August 2021 and ended December 2021. The exploratory outcomes included stress, depression, sleep, burn-out, resilience, quality of life, and cognition. RESULTS: Among the 40 HCP in study, the majority were female (85%), white (87.5%) and with an average age of 41.3 ± 11.0 years (SD). Participants used the wearable device an average of 23.8 times over a 30-day period with a mean duration of 5.8 min with each use. Study results demonstrate the positive impact of guided mindfulness using the wearable device MUSE-S™ and its accompanying application (APP). A statistically significant improvement was found for a reduction in stress (P < .001) and improvement in resilience (P = .02), quality of life (P = .003), and cognition (P < .001). The majority (91.9%) of the participants indicated they felt more relaxed after using the device, and 73% indicated they would continue to use this device at end-of-study. No adverse effects were reported. CONCLUSION: Study results show that 3 to 10 min of guided meditation during work hours through the use of a brain sensing wearable device is safe and acceptable, with associated health benefits for HCP.

Assessing vitamin D and mammographic breast density in Alaskan women.

Vitamin D deficiency and high breast density may be associated with increased breast cancer risk. We examined a possible association between vitamin D levels and mammographic breast density in a population of Alaskan women. Patients seen in the Mayo Clinic-Alaska Native Medical Center telemedicine program from December 2014 to December 2017 were enrolled in the study. Pearson correlation was used to estimate the association between mammographic breast density and vitamin D levels. Of the 33 women enrolled, 70% of women self-identified as American Indian/Alaskan Native, 12% as White, 6% as Native Hawaiian/Pacific Islander and 12% as other. Nineteen (58%) participants were taking vitamin D supplementation. No correlation was identified between breast density and serum vitamin D levels overall (correlation= -0.03). Larger studies controlling for vitamin supplementation are needed, as this association could potentially impact breast cancer rates in populations at risk for vitamin D deficiency.

Evaluation of Germline Genetic Testing Criteria in a Hospital-Based Series of Women With Breast Cancer.

PURPOSE: To determine the sensitivity and specificity of genetic testing criteria for the detection of germline pathogenic variants in women with breast cancer. MATERIALS AND METHODS: Women with breast cancer enrolled in a breast cancer registry at a tertiary cancer center between 2000 and 2016 were evaluated for germline pathogenic variants in 9 breast cancer predisposition genes (ATM, BRCA1, BRCA2, CDH1, CHEK2, NF1, PALB2, PTEN, and TP53). The performance of the National Comprehensive Cancer Network (NCCN) hereditary cancer testing criteria was evaluated relative to testing of all women as recommended by the American Society of Breast Surgeons. RESULTS: Of 3,907 women, 1,872 (47.9%) meeting NCCN criteria were more likely to carry a pathogenic variant in 9 predisposition genes compared with women not meeting criteria (9.0% v 3.5%; P < .001). Of those not meeting criteria (n = 2,035), 14 (0.7%) had pathogenic variants in BRCA1 or BRCA2. The sensitivity of NCCN criteria was 70% for 9 predisposition genes and 87% for BRCA1 and BRCA2, with a specificity of 53%. Expansion of the NCCN criteria to include all women diagnosed with breast cancer at ≤ 65 years of age achieved > 90% sensitivity for the 9 predisposition genes and > 98% sensitivity for BRCA1 and BRCA2. CONCLUSION: A substantial proportion of women with breast cancer carrying germline pathogenic variants in predisposition genes do not qualify for testing by NCCN criteria. Expansion of NCCN criteria to include all women diagnosed at ≤ 65 years of age improves the sensitivity of the selection criteria without requiring testing of all women with breast cancer.

Use of a Wearable EEG Headband as a Meditation Device for Women With Newly Diagnosed Breast Cancer: A Randomized Controlled Trial.

Background: Breast cancer diagnosis and treatment affect quality of life and stress and are associated with fatigue. Meditation interventions are effective strategies for patients with breast cancer but are often limited by poor access, high cost, substantial time commitment, and poor adherence. In this feasibility study, we investigated the use of a portable, wearable, electroencephalographic device for guided meditation practices by breast cancer patients during the period from breast cancer diagnosis until 3 months after surgical treatment. Methods: We enrolled women (age = 20-75 years) who had received a recent diagnosis of breast cancer and planned to undergo surgical treatment. Participants were randomly assigned to perform guided meditation with the device (intervention group) or receive CD-based stress-reduction education (control group). Surveys were used to measure stress, quality of life, and fatigue at baseline, within 4 days before surgery, up to 14 days after surgery, and at 3 months after surgery. Results: In the intervention group, 15 of 17 participants (88.2%) completed the study; in the control group, 13 of 13 participants completed the study (100%). Participants in both groups had less fatigue and stress and improved quality of life at 2 weeks and 3 months after surgery compared with baseline, but there were no significant intergroup differences at any time point. Conclusion: The use of this wearable electroencephalographic device for meditation is a feasible strategy for patients with breast cancer.

Randomized pilot trial of yoga versus strengthening exercises in breast cancer survivors with cancer-related fatigue.

PURPOSE: Fatigue is one of the most common and bothersome refractory symptoms experienced by cancer survivors. Mindful exercise interventions such as yoga improve cancer-related fatigue; however, studies of yoga have included heterogeneous survivorship populations, and the effect of yoga on fatigued survivors remains unclear. METHODS: We randomly assigned 34 early-stage breast cancer survivors with cancer-related fatigue (≥4 on a Likert scale from 1-10) within 1 year from diagnosis to a 12-week intervention of home-based yoga versus strengthening exercises, both presented on a DVD. The primary endpoints were feasibility and changes in fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). Secondary endpoint was quality of life, assessed by the Functional Assessment of Cancer Therapies-Breast (FACT-B). RESULTS: We invited 401 women to participate in the study; 78 responded, and we enrolled 34. Both groups had significant within-group improvement in multiple domains of the fatigue and quality of life scores from baseline to post-intervention, and these benefits were maintained at 3 months post-intervention. However, there was no significant difference between groups in fatigue or quality of life at any assessment time. Similarly, there was no difference between groups in adherence to the exercise intervention. CONCLUSIONS: Both DVD-based yoga and strengthening exercises designed for cancer survivors may be good options to address fatigue in breast cancer survivors. Both have reasonable uptake, are convenient and reproducible, and may be helpful in decreasing fatigue and improving quality of life in the first year post-diagnosis in breast cancer patients with cancer-related fatigue.

Surveillance and Care of the Gynecologic Cancer Survivor.

BACKGROUND: Care of the gynecologic cancer survivor extends beyond cancer treatment to encompass promotion of sexual, cardiovascular, bone, and brain health; management of fertility, contraception, and vasomotor symptoms; and genetic counseling. METHODS: This is a narrative review of the data and guidelines regarding care and surveillance of the gynecologic cancer survivor. We searched databases including PubMed, Cochrane, and Scopus using the search terms gynecologic cancer, cancer surveillance, and cancer survivor and reached a consensus for articles chosen for inclusion in the review based on availability in the English language and publication since 2001, as well as key older articles, consensus statements, and practice guidelines from professional societies. However, we did not undertake an extensive systematic search of the literature to identify all potentially relevant studies, nor did we utilize statistical methods to summarize data. We offer clinical recommendations for the management of gynecologic cancer survivors based on review of evidence and our collective clinical experience. RESULTS: Key messages include the limitations of laboratory studies, including CA-125, and imaging in the setting of gynecologic cancer surveillance, hormonal and non-hormonal management of treatment-related vasomotor symptoms and genitourinary syndrome of menopause, as well as recommendations for general health screening, fertility preservation, and contraception. CONCLUSIONS: A holistic approach to care extending beyond cancer treatment alone benefits gynecologic cancer survivors. In addition to surveillance for cancer recurrence and late treatment side effects, survivors benefit from guidance on hormonal, contraceptive, and fertility management and promotion of cardiovascular, bone, brain, and sexual health.

Caring for the breast cancer survivor's health and well-being.

The breast cancer care continuum entails detection, diagnosis, treatment, and survivorship. During this time, focus on the whole woman and medical concerns beyond the breast cancer diagnosis itself is essential. In this comprehensive review, we critically review and evaluate recent evidence regarding several topics pertinent to and specific for the woman living with a prior history of breast cancer. More specifically, we discuss the most recent recommendations for contraceptive options including long-acting reversible contraception and emergency contraception, fertility and pregnancy considerations during and after breast cancer treatment, management of menopausal vasomotors symptoms and vulvovaginal atrophy which often occurs even in young women during treatment for breast cancer. The need to directly query the patient about these concerns is emphasized. Our focus is on non-systemic hormones and non-hormonal options. Our holistic approach to the care of the breast cancer survivor includes such preventive health issues as sexual and bone health,which are important in optimizing quality of life. We also discuss strategies for breast cancer recurrence surveillance in the setting of a prior breast cancer diagnosis. This review is intended for primary care practitioners as well as specialists caring for female breast cancer survivors and includes key points for evidence-based best practice recommendations.

The evolution of mindfulness-based physical interventions in breast cancer survivors.

Survivors of breast cancer are faced with a multitude of medical and psychological impairments during and after treatment and throughout their lifespan. Physical exercise has been shown to improve survival and recurrence in this population. Mind-body interventions combine a light-moderate intensity physical exercise with mindfulness, thus having the potential to improve both physical and psychological sequelae of breast cancer treatments. We conducted a review of mindfulness-based physical exercise interventions which included yoga, tai chi chuan, Pilates, and qigong, in breast cancer survivors. Among the mindfulness-based interventions, yoga was significantly more studied in this population as compared to tai chi chuan, Pilates, and qigong. The participants and the outcomes of the majority of the studies reviewed were heterogeneous, and the population included was generally not selected for symptoms. Yoga was shown to improve fatigue in a few methodologically strong studies, providing reasonable evidence for benefit in this population. Improvements were also seen in sleep, anxiety, depression, distress, quality of life, and postchemotherapy nausea and vomiting in the yoga studies. Tai chi chuan, Pilates, and qigong were not studied sufficiently in breast cancer survivors in order to be implemented in clinical practice.

Bone density and structure in healthy postmenopausal women treated with exemestane for the primary prevention of breast cancer: a nested substudy of the MAP.3 randomised controlled trial.

BACKGROUND: Exemestane can prevent breast cancer in postmenopausal women. Because of potential widespread use, we examined the safety of exemestane on bone health. METHODS: In this nested safety substudy of the MAP.3 trial (a randomised, placebo-controlled, double-blind trial of exemestane 25 mg a day for the primary prevention of breast cancer), we included postmenopausal women from five centres who were eligible to participate in MAP.3, not osteoporotic, not receiving drugs for bone-related disorders, with baseline lumbar spine, total hip, and femoral neck T-scores above -2·0. The primary endpoint was percent change from baseline to 2 years in total volumetric bone mineral density (BMD) at the distal radius by high-resolution peripheral quantitative CT. The primary analysis was per protocol using a non-inferiority margin. This analysis was done earlier than originally planned because of the impending announcement of MAP.3 results and subsequent unmasking of patients to treatment assignment. This study is registered with ClinicalTrials.gov, number NCT01144468, and has been extended to 5 years of unmasked follow-up. FINDINGS: 351 women (176 given exemestane, 175 given placebo; median age 61·3 years [IQR 59·2-64·9]) met our inclusion criteria and completed baseline assessment. At the time of clinical cutoff, 242 women had completed 2-year follow-up (124 given exemestane, 118 given placebo). From baseline to 2 years, the mean percent change in total volumetric BMD at the distal radius was -6·1% (95% CI -7·0 to -5·2) in the exemestane group and -1·8% (-2·4 to -1·2) in the placebo group (difference -4·3%, 95% CI -5·3 to -3·2; p<0·0001). The lower limit of the 95% CI was lower than our non-inferiority margin of negative 4% (one-sided test for non-inferiority p=0·70), meaning the hypothesis that exemestane was inferior could not be rejected. At the distal tibia, the mean percent change in total volumetric BMD from baseline to 2 years was -5·0% (95% CI -5·5 to -4·4) in the exemestane group and -1·3% (-1·7 to -1·0) in the placebo group (difference -3·7%, 95% CI -4·3 to -3·0; p<0·0001). The mean percent change in cortical thickness was -7·9% (SD 7·3) in the exemestane group and -1·1% (5·7) in the placebo group at the distal radius (difference -6·8%, 95% CI -8·5 to -5·0; p<0·0001) and -7·6% (SD 5·9) in the exemestane group and -0·7% (4·9) in the placebo group at the distal tibia (difference -6·9%, -8·4 to -5·5; p<0·0001). Decline in areal BMD, as measured by dual-energy x-ray absorptiometry, in the exemestane group compared with the placebo group occurred at the lumbar spine (-2·4% [95% CI -3·1 to -1·7] exemestane vs -0·5% [-1·1 to 0·2] placebo; difference -1·9%, 95% CI -2·9 to -1·0; p<0·0001), total hip (-1·8% [-2·3 to -1·2] exemestane vs -0·6% [-1·1 to -0·1] placebo; difference -1·2%, -1·9 to -0·4; p=0·004), and femoral neck (-2·4% [-3·2 to -1·7] exemestane vs -0·8% [-1·5 to 0·1] placebo; difference -1·6%, -2·7 to -0·6; p=0·002). INTERPRETATION: 2 years of treatment with exemestane worsens age-related bone loss in postmenopausal women despite calcium and vitamin D supplementation. Women considering exemestane for the primary prevention of breast cancer should weigh their individual risks and benefits. For women taking exemestane, regular bone monitoring plus adequate calcium and vitamin D supplementation are important. To assess the effect of our findings on fracture risk, long-term follow-up is needed. FUNDING: Canadian Breast Cancer Research Alliance (Canadian Institutes of Health Research/Canadian Cancer Society).

Health behaviors among cancer survivors receiving screening mammography.

OBJECTIVES: The purpose of this study was to evaluate the prevalence of cancer-related behavioral risk factors among female cancer survivors, relative to women without a previous diagnosis of cancer. METHODS: In a large cohort of 19,948 women presenting for screening mammography, questionnaires on health behaviors were administered. RESULTS: A total of 18,510 had detailed history on health behaviors and previous cancer history. Overall 2713 (14.7%) reported a previous cancer history. We found statistically significant results indicating that cancer survivors were less likely than those with no cancer history to: report their overall health as "excellent" (13.6% vs. 21.5%), to engage in moderate or strenuous exercise (56.5% vs. 63.3%), and to use complementary and alternative medicine (57.4% vs. 60.2%). Conversely, cancer survivors were more likely to be current smokers (6.3% vs. 5.5%), rate their overall health as "poor" (15.8% vs. 9.1%), and to report more weight gain over time. Among cancer survivors, differences also emerged by the type of primary cancer. For example, cervical cancer survivors (n = 370) were most likely to report being current smokers (15.7%) and regular alcohol users (71.7%) compared with other survivors. Ovarian (n = 185) and uterine (n = 262) cancer survivors most frequently reported being obese (41% and 34.4%, respectively). Cervical cancer survivors reported the largest weight gain (4.9 lbs at 5 y and 13.4 lbs at 10 y). CONCLUSIONS: These results suggest opportunities for tailored behavioral health risk factor interventions for specific populations of cancer survivors.

Vitamin E and evening primrose oil for management of cyclical mastalgia: a randomized pilot study.

OBJECTIVE: To evaluate the effectiveness of vitamin E, evening primrose oil (EPO), and the combination of vitamin E and EPO for pain control in women with cyclical mastalgia. PROCEDURE: A double-blind, randomized, placebo-controlled trial was conducted at two U.S. academic medical centers. Eighty-five women with premenstrual cyclical breast discomfort were enrolled. Participants were randomly assigned to one of four six-month oral treatments: vitamin E (1,200 IU per day), EPO (3,000 mg per day), vitamin E (1,200 IU per day) plus EPO (3,000 mg per day), or double placebo. The primary outcome measure was change in breast pain, measured by the modified McGill Pain Questionnaire at enrollment and at six months. RESULTS: Forty-one patients completed the study. Intent-to-treat analysis (pretesting and post testing) showed a difference in worst-pain improvement with the treatments EPO (p=0.005), vitamin E (p=0.04), and EPO plus vitamin E (p=0.05), but no difference with placebo (p=0.93). Results from two-sample t-test showed a nonsignificant decrease in cyclical mastalgia individually for the three treatment groups compared with the placebo group (EPO, p=0.18; vitamin E, p=0.10; and EPO plus vitamin E, p=0.16). The data were also analyzed with the separation test by Aickin, which showed a trend toward a reduction of cyclical mastalgia with vitamin E and EPO individually and in combination. CONCLUSION: Daily doses of 1,200 IU vitamin E, 3,000 mg EPO, or vitamin E and EPO in combination at these same dosages taken for six months may decrease the severity of cyclical mastalgia.

Value of massage therapy for patients in a breast clinic.

This article examines interest in massage therapy and other forms of complementary and alternative medicine among patients with breast disease. Surveys were mailed to 63 patients who had a breast abnormality or a recent diagnosis of breast cancer and received complimentary massage therapy at Mayo Clinic in Rochester, MN, from February to April 2005. Thirty-five patients responded (56% response rate). All participants felt that massage therapy was effective in helping them relax, and 34 felt that it was very or somewhat effective in reducing muscle tension. More than 75% reported that massage therapy was effective in reducing fatigue, creating a general feeling of wellness, and improving sleep quality and their ability to think clearly. Although this study was small, the findings show that massage therapy may help patients with breast disease relax and feel better overall.

Pilot evaluation of flaxseed for the management of hot flashes.

The objective of this study was to evaluate, in a phase 2 pilot study, tolerability and the effect of 6 weeks of flaxseed therapy on hot flash scores in women not wishing to receive estrogen therapy. Eligibility included 14 hot flashes per week for at least 1 month. In the baseline week, participants took no study medication and documented the characteristics of their hot flashes. Thereafter, crushed flaxseed was administered at 40 g daily. Participants provided weekly toxicity reports and health-related quality of life information. The primary end point was a change in hot flash score prospectively reported in a daily hot flash diary. Thirty women were enrolled between June 17 and November 8, 2005. The mean decrease in hot flash scores after flaxseed therapy was 57% (median decrease 62%). The mean reduction in daily hot flash frequency was 50% (median reduction 50%), from 7.3 hot flashes to 3.6. Fourteen of the 28 participants (50%) experienced mild or moderate abdominal distention. Eight participants (29%) experienced mild diarrhea, one experienced flatulence, and six (21%) withdrew because of toxicities. This study suggests that dietary therapy decreases hot flash activity in women not taking estrogen therapy. This reduction is greater than what would be expected with placebo.