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Current Research Projects
Project Title Sleep, Circadian Hormonal Dysregulation and Breast Cancer Survival
Researcher David Spiegel, MD , Stanford School of Medicine
Study Abstract Recent research provides evidence that disrupted circadian rhythms are associated with increased risk of breast cancer incidence and faster progression to mortality. We have observed that loss of normal diurnal cortisol rhythm predicts early mortality with breast cancer. This disrupted rhythm is associated with more awakenings during the night. Recent studies have shown that nighttime shift work is associated with a higher risk of getting breast cancer, and in a murine model disrupting circadian cycles produced a doubling of implanted tumor growth. There is also recent evidence that abnormal clock genes are associated with cancer. Our data and those of others increasingly point toward disrupted circadian cycles having an effect on the body’s resistance to cancer. But a number of important questions remain unanswered:
1. What are circadian patterns of cortisol and melatonin at night?
2. Do stress and poor sleep cause disrupted cortisol (and other hormonal) dysregulation?
3. Does sleep disruption itself predict more rapid breast cancer progression?
We therefore propose to study coping with stress and associated sleep disruption as a prognostic factor in the progression of metastatic breast cancer, and in association with disrupted circadian patterns of cortisol, CRF, ACTH, prolactin, and melatonin, as well as measures of immune function. We plan to recruit 117 women with metastatic breast cancer and 63 age and SES-matched controls for a 32-hour sleep study in the General Clinical Research Center. This study has the potential to link mind and body in cancer through a careful examination of differences in coping with the inevitable stressors associated with cancer as they affect circadian sleep, hormonal, and immune cycles and potentially cancer progression.
Project Title The BEAM Study
Researcher Seema Khan, MD
Study Abstract Current methods to determine breast cancer risk are insufficiently sensitive to select women most likely to benefit from preventive strategies. Our preliminary data support the hypothesis that quantitative molecular markers (DNA methylation and breast tissue hormone concentrations) may provide an individualized risk profile. We will obtain random fine needle aspiration samples from 300 women of varying menopausal and menstrual status and evaluate cumulative gene methylation and breast estradiol concentrations. Ongoing commercial partnership will ensure development of a simple, inexpensive and noninvasive test. This work sets the stage for validation studies to test whether these early changes predict future breast cancer.
Project Title Pathways to Recovery After Breast Cancer
Researcher Annette Stanton, Ph.D. , University of California Los Angeles
Study Abstract PREPARATORY INTERVENTIONS FOR LIFE AFTER BREAST CANCER (project 3)
In the United States, over 2 million women live with a history of breast cancer. The re-entry transition from cancer patient to survivor is an understudied and challenging period. Using a theory-driven conceptual framework, Project 3 of this Cancer Information Service Research Consortium (CISRC) proposal involves development and testing of interventions to promote informed re-entry to life after breast cancer treatment. The six primary aims are to: (1) develop and test a highly innovative multimedia educational intervention (CD-ROM and internet delivery), the Virtual Cancer Information Service (V-CIS); (2) develop and test a telephone callback protocol conducted by the NCI's Cancer Information Service (CIS) Information Specialists; (3) evaluate these interventions in a randomized, 3-group stepped design for those with computer access: (a) Group 1=a control group receiving standard CIS service and print material (e.g., NCI's Facing Forward); (b) Group 2=standard care + V-CIS; (c) Group 3=standard care + V-CIS + CIS telephone callback. A two-group randomized feasibility study will be conducted for those without computer access: (d) Group 1A=control=same standard print as Group 1; (e) Group 2A=standard print + CIS intervention callback; (4) evaluate a theory-driven test of mediators (i.e., self-efficacy, perceived coping skill, perceived information utility) of intervention effects; (5) explore potential moderators (e.g., age, baseline distress) of intervention effects; (6) with the CIS, plan dissemination. To test the efficacy of the intervention, breast cancer callers to the CIS will be enrolled, and depending on computer access, randomized to the 3-group design (n = 1,080 at baseline) or the 2-group design (n = 150 at baseline), and followed at 2, 6, and 12 months post-baseline. Conforming to a dose-response gradient, the primary hypothesis is that Group 3 > Group 2 > Group 1 (and Group 2A > Group 1A) on the primary outcomes (i.e., cancer-specific distress and vitality) and additional outcomes in the domains of psychological health, physical health, interpersonal functioning, and life perspectives. Questions regarding how (i.e., mediators) and for whom (i.e., moderators) the interventions are effective also will be examined. Project 3 is unique in that it examines a state-of-the-science software program and proactive CIS-initiated telephone callback, thus addressing the primary service mission of the CIS. Contingent upon findings, the goal of the CISRC is to prepare the intervention for dissemination within the CIS, as well as other service programs nationwide.
Project Title The Milk Study: Using Breast Milk to Screen for Breast Cancer and Assess Breast-Cancer Risk
Researcher Kathleen Arcaro, PhD
Study Abstract Accurate assessment of breast-cancer-risk will benefit most women and analysis of promoter hypermethylation in exfoliated epithelial cells in breast milk provides an ideal opportunity to assess breast-cancer-risk.
Project Title The Patient-Physician Interface: How Breast Cancer Patients Navigate Fertility Concerns and Treatment Options
Researcher Karrie Snyder, PhD (IRB Approval STU00012672)
Study Abstract This research study looks at how younger women (under 40) and their doctors discuss issues regarding possible fertility impairment due to cancer treatment, how newly diagnosed women make treatment choices (including fertility conserving treatment options), and how fertility issues impact these women’s lives after cancer. Research has shown that while cancer treatment, such as chemotherapy, can impair a cancer patient’s future fertility, doctors and patients often do not discuss possible fertility risks or what can be done to help safeguard a woman’s fertility potential (such as emergency IVF). By interviewing both younger women with a history of breast cancer and physicians who treat such women, this research will look at how treatment decisions are made particularly fertility conserving treatment options and will identify factors that facilitate the discussion of fertility related issues between patient and physician. The research also examines how having a breast cancer diagnosis influences a woman’s life after cancer including her future family plans and family relationships including those with parents and partners.
Project Title A Yoga and Wellness Program for Breast Cancer Survivors with Persistent Fatigue
Researcher Julienne Bower, Ph.D. at the University of California, Los Angeles
Study Abstract There are currently over 2 million breast cancer survivors in the United States, many of whom experience persistent cancer-related symptoms. Fatigue is the most common and distressing symptom among women successfully treated for breast cancer and causes serious disruption in quality of life. Mind-body interactions such as yoga are popular among cancer patients and have shown beneficial effects on fatigue in other populations; however, yoga trials in cancer are scarce. Based on promising results from a small, single-arm pilot study, the proposed study will evaluate the feasibility, acceptability, and preliminary efficacy of an Iyengar yoga intervention for breast cancer survivors with persistent fatigue. In this randomized, controlled trial, 60 breast cancer survivors with persistent cancer-related fatigue will be randomly assigned to yoga or health education control for 12 weeks and followed for 3 months. The aims of the project are to: 1) determine the feasibility and acceptability of a 12-week Iyengar yoga intervention for breast cancer survivors with persistent fatigue as compared with health education control; 2) evaluate the effects of yoga vs. health education on fatigue and physical performance in breast cancer survivors with persistent fatigue; and 3) explore the effects of yoga vs. health education on behavioral and immune outcomes associated with cancer-related fatigue, including depressed mood, sleep, pain, proinflammatory cytokine activity, and quality of life. This project will constitute the first randomized, controlled trial of yoga for fatigue in breast cancer survivors and will provide key preliminary data to support a larger efficacy trial. In addition, the study will provide insight into secondary effects of yoga and generate hypotheses about potential mechanisms for intervention effects that can be systematically evaluated in a larger trial. The development of targeted treatments for cancer-related fatigue is critical for maintaining quality of life in the growing population of breast cancer survivors.
Project Title The Impact of Colonic Microbiota on Breast Cancer
Researcher Ece Mutlu, MD at Rush University Medical Center, Chicago, Illinois
Study Abstract The purpose of this study is to find out what type of bacteria can be found in the intestines and to look at the way the bacteria metabolize estrogen and other female hormones. The bacteria of women who have never had breast cancer will be compared to the bacteria of women who have been recently diagnosed with breast cancer.
Thirty (30) women who have never had breast cancer are needed for this study.
Project Title Protocol for Narrowing the Gap in Adjuvant Therapy
Researcher Vanessa Sheppard, PhD
Study Abstract At present, it is estimated that adjuvant therapy would be considered standard of care for up to 80% of women with invasive, non-metastatic disease, but many Black women eligible for adjuvant therapy are not receiving it or are receiving sub-optimal regimens. However, at present there are few data about Black women’s breast cancer experiences or factors that influence treatment adherence. The overarching goal of this career development award is to obtain the skills and experience needed to become an independent investigator focused on filling this knowledge gap.
Project Title Yoga for Breast Cancer Survivors: Effects on Fatigue, Immune Function, and Mood
Researcher Janice Kiecolt-Glaser, PhD
Study Abstract Breast cancer survivors confront a number of post-treatment problems including fatigue, decreased physical function, fears of recurrence, and treatment-related sequelae. Persistent fatigue, the most common and distressing problem, appears to be related in part to overactivation of the inflammatory network.
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