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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 DCIS and BRCA 1/ 2 Study
Researcher Elizabeth Claus, MD, PhD, at Yale University School of Medicine, New Haven, Connecticut
Study Abstract The role of ductal carcinoma in situ (DCIS) with respect to breast-ovarian cancer syndromes associated with the genes BRCA1 and BRCA2 is unclear. Recent findings indicate that the prevalence of disease-associated mutations in BRCA1/2 among women diagnosed with DCIS is similar to that for women diagnosed with invasive breast cancer. However, the pathologic and clinical characteristics of DCIS (and hence screening and treatment options) for BRCA1/2 carriers relative to non-carriers remains to be defined. Efforts to study this topic are important as 1) there is evidence of a low level of patient and clinician awareness that DCIS may be associated with BRCA1/2 and that, in carriers, standard treatment for DCIS may not be appropriate, 2) preliminary data suggest that DCIS in women with mutations in BRCA1/2 may progress more quickly to invasive breast cancer than for women without such mutations, and 3) up to 20% of screened breast cancer patients are diagnosed with DCIS; hence, in the coming century up to one in fifty women in the United States will likely be diagnosed with this tumor during her lifetime. At present, few women with DCIS have been tested for disease-associated mutations in BRCA1/2 and no single research center includes a sufficient number of patients for study. We propose a multi-center, collaborative effort to construct a sample of approximately 175 female BRCA1/2 carriers diagnosed with DCIS drawn from a population-based case/control study of DCIS as well as from a number of large high-risk cancer clinics across the United States in an effort to define preliminary estimates of outcome for these women. The goals of this application are: 1) To provide annual and five-year cumulative estimates of ipsilateral and contralateral breast cancer risk, as well as risk of ovarian cancer and death for women diagnosed with DCIS and who have mutations in BRCA1/2, 2) To compare these risks with those for women diagnosed with DCIS and who do not carry mutations in BRCA1/2 and those for women not diagnosed with DCIS (controls), 3) To measure and compare the prevalence of pathologic characteristics (estrogen, progesterone, erbB-2, and Ki-67 (MIB-1) receptor positivity as well as tumor size, grade and comedo necrosis) of DCIS diagnosed in women with mutations in BRCA1/2 with those in DCIS patients without such mutations, 4) To present preliminary risk models and clinical guidelines for the management of DCIS in BRCA1/2 mutation carriers.
Project Title The Milk Study: Using Breast Milk to Screen for Breast Cancer and Assess Breast-Cancer Risk
Researcher Kathleen Arcaro, Ph.D. at the Universtiy of Massachusetts, Amherst
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 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 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.
Project Title Envision the Rhythms of Life
Researcher Lyn Freeman, Ph.D., of Mind Matters Research in Anchorage, Alaska
Study Abstract To improve quality of life and reduce stress for breast cancer survivors. Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life, stress reduction, participant satisfaction with product) of the "Envision the Rhythms of Life" program and (2) to establish the technical merits of the program's distance-delivery (videoconferencing hardware and software) and instructional technology (i.e., animations, graphically enhanced PowerPoint instructional materials, full-color program manuals, art-as-imagery, and audio-imagery). "Envision the Rhythms of Life" instructs breast cancer survivors in the practice of individualized, emotionally supportive, and biologically accurate imagery and consists of 5, 3-hour long, interactive classes and between-class instructor support. Instructional Options: Option 1 delivers the program technology (animations, PowerPoint, manuals, art, audio-art) with instructor and 15 participants in the same room. Option 2 delivers the program at-a-distance, to a small group of 15, via videoconferencing software and camera systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers program three times (total of 45 participants for each option). A website portal provides all program information and materials. Design and Method: Program will be delivered to 135 breast cancer survivors who have completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks. Differences in option 1 and 2 outcomes will be compared to each other and to controls; combined outcomes of option 1 and 2 will be compared to controls; and waitlist control outcomes will be compared to their extended baseline. Long-Term Objectives: This innovative project integrates technology with bandwidth-sensitive multi-media conferencing strategies to deliver a virtual mind-body, imagery intervention. The technology will allow seamless program delivery to interested survivors across the country during Phase III. Instructional technology, designed per Phase I participant feedback, will serve to `jump-start' potent imagery practice and will optimize clinical efficacy. Commercial application and survivor participation is not limited by location, work schedule, or health status, addressing issues of barriers to access of care. Although desirable, instructional options 1 and 2 do not require survivors to have computer skills or internet access. The program is designed to be culturally sensitive and supports individual spiritual practices. PUBLIC HEALTH RELEVANCE: This program addresses NCI and IOM summary reports that call for individualized supportive care for cancer survivors suffering disease-related distress. Changes in two disease-education program modules would allow the program to be used as supportive therapy for other forms of cancer across the country.
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