Emerging From the Haze™: Pilot Feasibility Study Comparing Two Virtual Formats of a Cognitive Rehabilitation Intervention.

OBJECTIVES: To gather feasibility and preliminary data comparing two virtual delivery methods for providing Emerging From the Haze™ (Haze) to cancer survivors compared to waitlist control (WLC). SAMPLE & SETTING: Eligible participants (N = 93) reported cancer-related cognitive impairment following chemotherapy for stage I-III solid tumors, Hodgkin lymphoma, or non-Hodgkin lymphoma. METHODS & VARIABLES: A three-arm randomized design was used to compare virtual live group presentation of Haze sessions, virtual prerecorded Haze group sessions, and WLC. Data were collected at baseline, week 10, and week 14. RESULTS: Feasibility was demonstrated. Significant cognitive function improvement at week 10 versus WLC was reported for the live group, and clinical improvement was reported for the prerecorded group. The prerecorded group reported significant improvement at week 14 versus WLC in physical activity, sleep, and health-related quality of life. IMPLICATIONS FOR NURSING: Additional pilot and feasibility evidence for cognitive rehabilitation interventions was demonstrated. Prerecorded Haze delivery shows potential for clinical effectiveness and scalability. Future multisite research is warranted.

Experiences of genetic counselors in referring young and metastatic breast cancer patients to support services: A needs assessment.

OBJECTIVE: Conduct a needs assessment to explore the experiences, barriers, and needs of genetic counselors (GCs), who counsel and refer young and metastatic breast cancer (BC) patients to support services, in order to develop resources to address any noticeable gaps. METHODS: GCs providing care to BC patients were eligible to complete the survey. Support services were defined as resources to address patient-centered healthcare, emotional, and quality-of-life needs. RESULTS: Most participants (n = 117) reported familiarity with cancer prevention services (93%); fewer were familiar with services secondary to a BC diagnosis (e.g., fatigue=16% and sexual health=24%). The volume of GCs indicating familiarity with support services increased significantly as work experience increased for seven services. Many (>50%) never referred patients to most (9/12) support services, excluding cancer prevention, mental health, and financial issues. Open-ended responses highlighted that GCs considered referrals to be outside their scope of practice or that healthcare systems prevent GCs from making referrals. CONCLUSION: GCs may benefit from curated resources and materials, especially for support services secondary to a BC diagnosis, to better support their patients. PRACTICAL IMPLICATIONS: Collaboration of GCs with other health professionals through integrative care programs may decrease burdens to accessing support services.

Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors.

Aerobic exercise reduces risk for breast cancer and recurrence and promotes visceral adipose tissue (VAT) loss in obesity. However, few breast cancer survivors achieve recommended levels of moderate to vigorous physical activity (MVPA) without supervision. In a two-cohort study, feasibility of 12 weeks of partially supervised exercise was started concomitantly with caloric restriction and effects on body composition and systemic risk biomarkers were explored. In total, 22 obese postmenopausal sedentary women (including 18 breast cancer survivors) with median age of 60 and BMI of 37 kg/m2 were enrolled. Using personal trainers twice weekly at area YMCAs, MVPA was escalated to ≥200 min/week over 9 weeks. For cohort 2, maintenance of effect was assessed when study provided trainer services were stopped but monitoring, group counseling sessions, and access to the exercise facility were continued. Median post-escalation MVPA was 219 min/week with median 12-week mass and VAT loss of 8 and 19%. MVPA was associated with VAT loss which was associated with improved adiponectin:leptin ratio. In total, 9/11 of cohort-2 women continued the behavioral intervention for another 12 weeks without trainers. High MVPA continued with median 24-week mass and VAT loss of 12 and 29%. This intervention should be further studied in obese sedentary women.

Change in Blood and Benign Breast Biomarkers in Women Undergoing a Weight-Loss Intervention Randomized to High-Dose ω-3 Fatty Acids versus Placebo.

The inflammation-resolving and insulin-sensitizing properties of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids have potential to augment effects of weight loss on breast cancer risk. In a feasibility study, 46 peri/postmenopausal women at increased risk for breast cancer with a body mass index (BMI) of 28 kg/m2 or greater were randomized to 3.25 g/day combined EPA and DHA (ω-3-FA) or placebo concomitantly with initiation of a weight-loss intervention. Forty-five women started the intervention. Study discontinuation for women randomized to ω-3-FA and initiating the weight-loss intervention was 9% at 6 months and thus satisfied our main endpoint, which was feasibility. Between baseline and 6 months significant change (P < 0.05) was observed in 12 of 25 serum metabolic markers associated with breast cancer risk for women randomized to ω-3-FA, but only four for those randomized to placebo. Weight loss (median of 10% for trial initiators and 12% for the 42 completing 6 months) had a significant impact on biomarker modulation. Median loss was similar for placebo (-11%) and ω-3-FA (-13%). No significant change between ω-3-FA and placebo was observed for individual biomarkers, likely due to sample size and effect of weight loss. Women randomized to ω-3-FA exhibiting more than 10% weight loss at 6 months showed greatest biomarker improvement including 6- and 12-month serum adiponectin, insulin, omentin, and C-reactive protein (CRP), and 12-month tissue adiponectin. Given the importance of a favorable adipokine profile in countering the prooncogenic effects of obesity, further evaluation of high-dose ω-3-FA during a weight-loss intervention in obese high-risk women should be considered. PREVENTION RELEVANCE: This study examines biomarkers of response that may be modulated by omega-3 fatty acids when combined with a weight-loss intervention. While focused on obese, postmenopausal women at high risk for development of breast cancer, the findings are applicable to other cancers studied in clinical prevention trials.

Feasibility of a Weight Management Program Tailored for Overweight Men with Localized Prostate Cancer - A Pilot Study.

BACKGROUND: Overweight men with prostate cancer are more likely to suffer from recurrence and death following prostatectomy compared with healthy weight men. This study tested the feasibility of delivering a comprehensive program to foster weight loss before and weight maintenance after surgery in overweight men with localized prostate cancer. METHODS: Twenty overweight men scheduled for prostatectomy elected either the intervention (n = 15) or the nonintervention (n = 5). Anthropometrics, biomarkers, diet quality, nutrition literacy, quality of life, and long-term follow-up were assessed in both groups. RESULTS: The intervention led to 5.55 kg of weight loss including 3.88 kg of fat loss from baseline to surgery (mean = 8.3 weeks). The intervention significantly increased fiber, protein, fruit, nut, and vegetable intake; and decreased trans fats intake during weight loss. The intervention significantly reduced insulin, C-peptide, systolic blood pressure, leptin:adiponectin ratio, and visceral adiposity compared to the nonintervention. Post-surgically, weight loss was maintained. Changes in lipid profiles, nutrition literacy, and follow-up were not statistically significant in either group. CONCLUSION: Significant weight loss (≥5%) is feasible with a coaching intervention in overweight men preparing for prostatectomy and is associated with favorable cardiometabolic effects. This study is registered under NCT02252484 (www.clinicaltrials.gov).

Implementing a stepwise educational approach for bridging the gap between specialty and primary care for childhood cancer survivors.

PURPOSE: To create a community of learning involving primary care providers and subspecialist to enhance providers' knowledge regarding care of adult childhood cancer survivors (CCS). METHODS: A stepwise approach was used to develop educational opportunities for providers. This process started with a local/regional in-person conference, which informed a webinar series, and resulted in the development of enduring material using a dynamic learning management system. RESULTS: Participants in all three learning platforms had an increase in knowledge from baseline regarding care for adult CCS. Majority of participants at the in-person conference and webinar series were oncology or other specialty providers. The enduring dynamic learning management system successfully reached a variety of providers and other allied health providers across the country. There was a slightly higher rate of participation on this platform by primary care providers of 12.5%. CONCLUSIONS: Care providers' knowledge of survivorship needs of adult CCS can be increased by multiple forms of instruction. However, the dynamic learning management system was most successful at reaching a broad audience. Advertisement through local and national organizations was not as successful as anticipated. Additional strategies are needed to successfully engage providers, specifically primary care providers (PCPs). IMPLICATIONS FOR CANCER SURVIVORS: The professional development needs of primary care providers regarding care of adult CCS is well recognized. A dynamic learning management system may represent the most convenient and accessible way to provide education, but new strategies for increasing providers' awareness and engagement are required. The goal of improving care of adult CCS requires increased providers knowledge.

Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer.

We conducted a multiinstitutional, placebo-controlled phase IIB trial of the lignan secoisolariciresinol diglucoside (SDG) found in flaxseed. Benign breast tissue was acquired by random periareolar fine needle aspiration (RPFNA) from premenopausal women at increased risk for breast cancer. Those with hyperplasia and ≥2% Ki-67 positive cells were eligible for randomization 2:1 to 50 mg SDG/day (Brevail) versus placebo for 12 months with repeat bio-specimen acquisition. The primary endpoint was difference in change in Ki-67 between randomization groups. A total of 180 women were randomized, with 152 ultimately evaluable for the primary endpoint. Median baseline Ki-67 was 4.1% with no difference between arms. Median Ki-67 change was -1.8% in the SDG arm (P = 0.001) and -1.2% for placebo (P = 0.034); with no significant difference between arms. As menstrual cycle phase affects proliferation, secondary analysis was performed for 117 women who by progesterone levels were in the same phase of the menstrual cycle at baseline and off-study tissue sampling. The significant Ki-67 decrease persisted for SDG (median = -2.2%; P = 0.002) but not placebo (median = -1.0%). qRT-PCR was performed on 77 pairs of tissue specimens. Twenty-two had significant ERα gene expression changes (<0.5 or >2.0) with 7 of 10 increases in placebo and 10 of 12 decreases for SDG (P = 0.028), and a difference between arms (P = 0.017). Adverse event incidence was similar in both groups, with no evidence that 50 mg/day SDG is harmful. Although the proliferation biomarker analysis showed no difference between the treatment group and the placebo, the trial demonstrated use of SDG is tolerable and safe.

Factors associated with genetic testing in a cohort of breast cancer survivors.

We examined factors associated with self-reported use of genetic testing among breast cancer survivors based on a 2015 cross-sectional survey at eight Midwestern sites. Genetic testing was reported in 39% of our 1235 study participants, with higher utilization among those aged <50 and with a triple-negative cancer. Bilateral mastectomy, having relatives with breast cancer, and younger age were associated with increased genetic testing use. Increasing income, in interaction with age, was associated with use of genetic testing among younger but not older patients. Rural residency emerged as a possible barrier for genetic testing among women with triple-negative cancer.

Moving beyond static survivorship care plans: A systems engineering approach to population health management for cancer survivors.

The American cancer survivor population is ever-growing, with necessary follow-up primarily accomplished in a high-touch fashion-adding to unsustainability and fragmentation of care. Given the complexities of the health care system processes needed to support survivorship, engineering approaches may best address performance deficits and facilitate the provision of patient-centered care. Such collaboration between health care and engineering is recommended for redesigning health care delivery systems. By using Systems Engineering Initiative for Patient Safety (SEIPS), a systems engineering model widely used to improve health care quality and delivery, the authors examine the work system to identify the barriers and facilitators to necessary care in the presence of a survivorship care plan and visit. Recommendations for future improvement include ensuring that care-planning processes are dynamic, clearly assigned, resilient, and integrated with electronic health record systems.

Breast Cancer Risk Among Women in Jail.

Over 200,000 women are diagnosed with breast cancer each year, and incarcerated women face unique risks associated with poor access to healthcare. Regular mammography can diagnose breast cancer early, giving the patient the best chance of survival. The objective of this study was to determine the proportion of jail incarcerated women who have received a mammogram and were up-to-date based on the most recent United States Preventive Services Task Force recommendations. This was a secondary analysis of data collected among jailed women who participated in a cervical cancer literacy program. Rates of mammography were calculated for the group overall and for those women 50 years or older. Subgroups were compared using chi-squared tests. Two hundred sixty-one women were included in the analysis, of which 42.1% (N = 110) had ever had a mammogram. Of women 50 years old or older (N = 28), 75.0% had ever received a mammogram, yet only 39.3% were up-to-date (within the past 2 years). Factors associated with up-to-date mammography included being up-to-date on cervical cancer screening (76.9%) compared with women who were not up-to-date on cervical cancer screening (12.5%), p < 0.01, and women experiencing intimate partner violence (IPV) in the past year (71.4%) compared with women with no IPV in the past year (14.2%), p = 0.02. The low rates of up-to-date mammography highlight the need for more breast cancer prevention programming among women with criminal justice histories.

Pathological Response and Survival in Triple-Negative Breast Cancer Following Neoadjuvant Carboplatin plus Docetaxel.

PURPOSE: Prognostic value of pathologic complete response (pCR) and extent of pathologic response attained with anthracycline-free platinum plus taxane neoadjuvant chemotherapy (NAC) in triple-negative breast cancer (TNBC) is unknown. We report recurrence-free survival (RFS) and overall survival (OS) according to degree of pathologic response in patients treated with carboplatin plus docetaxel NAC. PATIENTS AND METHODS: One-hundred and ninety patients with stage I-III TNBC were treated with neoadjuvant carboplatin (AUC6) plus docetaxel (75 mg/m2) every 21 days × 6 cycles. pCR (no evidence of invasive tumor in breast and axilla) and Residual cancer burden (RCB) were evaluated. Patients were followed for recurrence and survival. Extent of pathologic response was associated with RFS and OS using the Kaplan-Meier method. RESULTS: Median age was 51 years, and 52% were node-positive. pCR and RCB I rates were 55% and 13%, respectively. Five percent of pCR patients, 0% of RCB I patients, and 58% of RCB II/III patients received adjuvant anthracyclines. Three-year RFS and OS were 79% and 87%, respectively. Three-year RFS was 90% in patients with pCR and 66% in those without pCR [HR = 0.30; 95% confidence interval (CI), 0.14-0.62; P = 0.0001]. Three-year OS was 94% in patients with pCR and 79% in those without pCR (HR = 0.25; 95% CI, 0.10-0.63; P = 0.001). Patients with RCB I demonstrated 3-year RFS (93%) and OS (100%) similar to those with pCR. On multivariable analysis, higher tumor stage, node positivity, and RCB II/III were associated with worse RFS. CONCLUSIONS: Neoadjuvant carboplatin plus docetaxel yields encouraging efficacy in TNBC. Patients achieving pCR or RCB I with this regimen demonstrate excellent 3-year RFS and OS without adjuvant anthracycline.

Incorporating Digital Tools to Improve Clinical Trial Infrastructure: A White Paper From the Digital Engagement Committee of SWOG.

Progress toward improvement in cancer therapy relies on clinical trials. Yet, only a minority of eligible patients with cancer enroll as a result of multiple barriers at the patient, investigator, center, and national level. However, the rise of the Internet and mobile technology has created a slew of tools with medical applications, from Web sites to apps to social media platforms, all of which may aide clinicians in our quest to improve the clinical research enterprise. SWOG is one of five members in the National Cancer Institute's National Clinical Trials Network-the nation's oldest and largest publicly funded cancer research network-and is taking a leadership role in exploring and testing the promise of digital engagement through the empaneling of the Digital Engagement Committee. This article outlines the mission, principles, and priorities of the Digital Engagement Committee and proposes how this work may inform the use of digital tools for the cancer research community and, hopefully, translate to improved outcomes for our patients.

Cognitive functioning and quality of life following chemotherapy in pre- and peri-menopausal women with breast cancer.

PURPOSE: The purpose of the study was to prospectively examine changes in subjective and objective cognitive functions and quality of life (QOL) for pre- and peri-menopausal women receiving chemotherapy for breast cancer and to explore potential predictors of cognitive changes. METHODS: Participants were assessed as follows: prior to chemotherapy (T1), after cycle 3 (T2), within 2-3 weeks of completing adjuvant chemotherapy (T3) (N = 20), and 8+ years later (T4; n = 18). Objective cognitive function was measured with the High Sensitivity Cognitive Screen (T1, T3, T4). Subjective measures for cognitive function, depressive symptoms, fatigue, and mental and physical QOL were assessed at all time points. Estradiol levels were measured at T1, T2, and T3. The Functional Assessment of Cancer Therapy-Cognition and the MD Anderson Cancer Symptom Inventory item for neuropathy were administered at T4. RESULTS: No significant changes in objective cognitive function were found. However, participants reported decreased cognitive function over the course of treatment accompanied by depressive symptoms and fatigue. Depression and fatigue returned to near-baseline levels at T4, but over half of the participants continued to report mild to moderate depression. Estradiol levels were not associated with cognitive function. Neuropathy and higher body mass index (BMI) were associated with persistent cognitive complaints at T4 (adjusted R 2 = 0.712, p = 0.001). Higher QOL was correlated with better subjective cognitive function (r = 0.705, p = 0.002) and lower body mass index (r = - 0.502, p = 0.017) at T4. CONCLUSIONS: Further investigation of BMI, neuropathy, and depressive symptoms as predictors of persistent cognitive dysfunction following chemotherapy for breast cancer is warranted.

Randomized trial of vitamin D3 to prevent worsening of musculoskeletal symptoms in women with breast cancer receiving adjuvant letrozole. The VITAL trial.

PURPOSE: Aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) frequently occur in women being treated for breast cancer. Prior studies suggest high prevalence of vitamin D deficiency in breast cancer patients with musculoskeletal (MS) pain. We conducted a randomized, placebo-controlled trial to determine if 30,000 IU vitamin D3 per week (VitD3) would prevent worsening of AIMSS in women starting adjuvant letrozole for breast cancer. METHODS: Women with stage I-III breast cancer starting adjuvant letrozole and 25(OH)D level ≤40 ng/ml were eligible. All subjects received standard daily supplement of 1200 mg calcium and 600 IU vitamin D3 and were randomized to 30,000 IU oral VitD3/week or placebo. Pain, disability, fatigue, quality of life, 25(OH)D levels, and hand grip strength were assessed at baseline, 12, and 24 weeks. The primary endpoint was incidence of an AIMSS event. RESULTS: Median age of the 160 subjects (80/arm) was 61. Median 25OHD (ng/ml) was 25 at baseline, 32 at 12 weeks, and 31 at 24 weeks in the placebo arm and 22, 53, and 57 in the VitD3 arm. There were no serious adverse events. At week 24, 51% of women assigned to placebo had a protocol defined AIMSS event (worsening of joint pain using a categorical pain intensity scale (CPIS), disability from joint pain using HAQ-II, or discontinuation of letrozole due to MS symptoms) vs. 37% of women assigned to VitD3 (p = 0.069). When the brief pain inventory (BPI) was used instead of CPIS, the difference was statistically significant: 56 vs. 39% (p = 0.024). CONCLUSIONS: Although 30,000 IU/week of oral vitamin D3 is safe and effective in achieving adequate vitamin D levels, it was not associated with a decrease in AIMSS events based on the primary endpoint. Post-hoc analysis using a different tool suggests potential benefit of vitamin D3 in reducing AIMSS.

Efficacy of Neoadjuvant Carboplatin plus Docetaxel in Triple-Negative Breast Cancer: Combined Analysis of Two Cohorts.

PURPOSE: Recent studies demonstrate that addition of neoadjuvant (NA) carboplatin to anthracycline/taxane chemotherapy improves pathologic complete response (pCR) in triple-negative breast cancer (TNBC). Effectiveness of anthracycline-free platinum combinations in TNBC is not well known. Here, we report efficacy of NA carboplatin + docetaxel (CbD) in TNBC. EXPERIMENTAL DESIGN: The study population includes 190 patients with stage I-III TNBC treated uniformly on two independent prospective cohorts. All patients were prescribed NA chemotherapy regimen of carboplatin (AUC 6) + docetaxel (75 mg/m2) given every 21 days × 6 cycles. pCR (no evidence of invasive tumor in the breast and axilla) and residual cancer burden (RCB) were evaluated. RESULTS: Among 190 patients, median tumor size was 35 mm, 52% were lymph node positive, and 16% had germline BRCA1/2 mutation. The overall pCR and RCB 0 + 1 rates were 55% and 68%, respectively. pCRs in patients with BRCA-associated and wild-type TNBC were 59% and 56%, respectively (P = 0.83). On multivariable analysis, stage III disease was the only factor associated with a lower likelihood of achieving a pCR. Twenty-one percent and 7% of patients, respectively, experienced at least one grade 3 or 4 adverse event. CONCLUSIONS: The CbD regimen was well tolerated and yielded high pCR rates in both BRCA-associated and wild-type TNBC. These results are comparable with pCR achieved with the addition of carboplatin to anthracycline-taxane chemotherapy. Our study adds to the existing data on the efficacy of platinum agents in TNBC and supports further exploration of the CbD regimen in randomized studies. Clin Cancer Res; 23(3); 649-57. ©2016 AACR.

Weight loss maintenance strategies among rural breast cancer survivors: The rural women connecting for better health trial.

OBJECTIVE: Obesity is a risk factor for breast cancer recurrence. Rural women have higher obesity rates compared with urban women and are in need of distance-based interventions that promote long-term weight loss. METHODS: In this two-phase trial, rural breast cancer survivors who lost >5% of their starting weight during a 6-month lifestyle intervention (delivered through weekly group conference calls) were randomized to one of two 12-month interventions for weight loss maintenance: continued biweekly phone-based group counseling or mailed newsletters. The primary outcome was weight regain from 6 to 18 months. Secondary outcomes included dichotomous measures of weight change and costs. RESULTS: Mean weight loss at 6 months was 14.0 ± 5.1%. Participants in the group phone condition regained less weight (3.3 ± 4.8 kg) compared with participants in the newsletter condition (4.9 ± 4.8 kg; P = 0.03). At 18 months, 75.3% of participants in the group phone condition remained ≥5% below baseline weight compared with 57.8% in the newsletter condition (P = 0.02). Incremental cost-effectiveness ratios were $882 to keep one more person ≥5% below baseline weight. CONCLUSIONS: A lifestyle intervention incorporating group phone-based support improved the magnitude of weight loss maintained and increased the proportion of survivors who maintained clinically significant reductions.

A Collaborative Step-Wise Process to Implementing an Innovative Clinic for Adult Survivors of Childhood Cancer.

With a 5 year survival rate of approximately 80%, there is an increasing number of childhood cancer survivors in the United States. Childhood cancer survivors are at an increased risk for physical and psychosocial health problems many years after treatment. Long-term follow-up care should include education, development of individualized follow up plans and screening for health problems in accordance with the Children's Oncology Group survivor guidelines. Due to survivor, provider and healthcare system related barriers, adult survivors of childhood cancer (ASCC) infrequently are receiving care in accordance to these guidelines. In this paper we describe the stepwise process and collaboration between a children's hospital and an adult academic medical center that was implemented to develop the Survivorship Transition Clinic and address the needs of ASCC in our region. In the clinic model that we designed ASCC follow-up with a primary care physician in the adult setting who is knowledgeable about late effects of childhood cancer treatment and are provided transition support and education by a transition nurse navigator.

Breast cancer prevention across the cancer care continuum.

OBJECTIVES: To review the current state of breast cancer prevention from primary prevention through survivorship, highlight cross-cutting issues, and discuss strategies for clinical integration and future research. DATA SOURCES: Published articles between 1985 and 2015 and original research. CONCLUSION: Cancer risk persists across the lifespan. Interprofessional strategies to reduce morbidity and mortality from cancer include primary, secondary, and tertiary prevention (survivorship). Prevention strategies across the cancer care continuum are cross-cutting and focus on measures to: prevent the onset of disease, identify and treat asymptomatic persons who have already developed risk factors or preclinical disease, and restore function, minimize the negative effects of disease, and prevent disease-related complications. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses and advanced practice nurses are vital in the delivery of breast cancer prevention strategies.

Survivorship care planning: one size does not fit all.

OBJECTIVES: To describe the delivery of survivorship care and methods to stratify risk to support the notion that "one size does not fit all." DATA SOURCES: Published articles between 2007 and 2014 and original research findings. CONCLUSION: The development and implementation of survivorship care into practice provides barriers and opportunities. National mandates are pushing the delivery of a survivorship care plan, which requires the ability to develop and deliver this tool and the necessary health care delivery model to manage the unique needs of each cancer survivor. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses and advanced practice nurses will play a crucial role in the development of survivorship care from education and assessment to the delivery of coordinated care.