The Young, Empowered and Strong Study
Ann Partridge, MD, MPH has launched a web-based supportive care intervention for young women with breast cancer. The YES Portal is an online, web-based platform, where young women can self-monitor their physical and psychosocial symptoms and track their progress. Study participants are also provided links to supportive care resources and can connect with other young women in a forum called the YES Chat.
This study is currently enrolling young women newly diagnosed with breast cancer, young women living with advanced disease, and survivors of early-stage breast cancer.
Pathways to Wellness
Pathways to Wellness compared the effectiveness of two group programs on meeting the common needs of younger breast cancer survivors. Participants were randomized to a six-week session of mindfulness meditation or survivorship education classes and completed surveys and blood draws at pre- and post-class study visits. The study enrolled about 250 women diagnosed with early-stage breast cancer at age 50 or younger within the past five years. It is a collaboration between the University of California, Los Angeles (UCLA), Dana-Farber Cancer Institute (DFCI), and Johns Hopkins University (JHU), funded by the National Cancer Institute.
This study is now closed to enrollment and is in data analysis.
Improving Surgical Decision-Making in Young Women with Breast Cancer
Shoshana Rosenberg, ScD, MPH, is the principal investigator of a study, sponsored in part by the Agency for Healthcare Research and Quality, that assesses young women’s surgical decision-making from both the patient and physician perspective. Dr. Rosenberg conducted in-person interviews and focus groups with young women with breast cancer about their surgical decisions and experiences. Additionally, she interviewed oncology providers about their perspective and how they communicate with breast cancer patients about local therapy decisions. The results from this qualitative assessment have informed ongoing research on a decision aid tool developed to help women make informed choices about their breast cancer surgery.
The decision aid was tested in a pilot study that is now closed to enrollment and in data analysis.
The POSITIVE (Pregnancy Outcome and Safety of Interrupting Therapy for Women with Endocrine Responsive Breast Cancer) Trial
Ann Partridge, MD, MPH is the North American Principal Investigator for the POSITIVE trial. This clinical trial is a prospective observational study designed to support and evaluate disease, reproductive, and psychosocial outcomes for young women who desire a pregnancy and at the same time are advised to receive 5-10 years of endocrine therapy for hormone receptor-positive early stage breast cancer. Enrolled women stop taking endocrine therapy 18-30 months into their treatment in order to become pregnant; afterwards they restart their medications to complete the planned duration of therapy.
The study is closed to enrollment.
Helping Ourselves, Helping Others
In 2006, Ann Partridge, MD, MPH, launched the first multi-institutional cohort study of young women with breast cancer in the United States. The Young Women's Breast Cancer Study (YWBCS, known to participants as Helping Ourselves, Helping Others) has enrolled more than 1300 young women. While the cohort is no longer enrolling patients, researchers will continue to survey participants for at least 10 years, tracking the medical and psychosocial issues these women face at diagnosis, through treatment, and into survivorship.
To date, the study has explored several issues particular to young women, including fertility concerns, sexual functioning, body image, genetic testing, differences in the time frame of diagnosis, and surgical decisions. Participants are also asked to provide blood and tissue samples for biological analyses to better understand the unique biology of breast cancer in young women. Some areas of interest include genetic risk factors that disproportionately affect young women diagnosed with breast cancer, as well a better understanding of the biology of metastatic disease, HER2+ tumors, and triple negative disease.
Dr. Partridge has collaborated with Nikhil Wagle, MD, a medical oncologist at Dana-Farber and a scientist at the Broad Institute, to examine genetic changes in very young women using blood and tumor samples collected through the cohort. Through this work, the investigators have searched for novel genetic markers, beyond BRCA1 and BRCA2, which might explain why some women develop breast cancer at a young age. We hope findings from this research will lead to the identification of potential targets for tailored prevention and treatment strategies.
The CHIP Study, a sub investigation, is examining clonal hematopoiesis of indeterminate potential (CHIP). People with CHIP are at higher risk for developing problems such as cancer and heart problems. Using the YWBCS, we are exploring whether the young breast survivors are at risk for developing CHIP due to the treatment they receive. We will use the YWBCS collected blood samples and data to determine the prevalence of CHIP in his group of survivors. Also, in this sub-study we will be surveying participants to try and understand survivors’ perceptions, preferences, and concerns of CHIP prior to integrating CHIP into survivorship care practices.
This study is closed to enrollment and active follow-up continues.
The Virtual Young Women's Initiative
Ann Partridge, MD, MPH received a three-year, American Society of Clinical Oncology (ASCO) Cancer Foundation Improving Cancer Care Grant to expand the domain of the Program for Young Women with Breast Cancer into a national, virtual program called the Young and Strong Program.
The virtual program provided educational and support materials for young women with breast cancer and their providers. The study compared a young women's intervention arm to a contact-time, physical activity intervention arm. Women in each arm were given a booklet, which included resource links, as well as access to a study website, which included videos from experts in the field. Print and website content was intended to help patients and their doctors understand and address the concerns of young women.
There have been four papers published to date. The team will use the findings to continue to refine the model of care for the Program for Young Women with Breast Cancer for community cancer settings and study the effect of the expanded program on fertility issues and other measures of quality of care, satisfaction, and quality of life.
This study is closed to enrollment and is in data analysis.
Young Women and Fertility Issues
An internet-based survey of 1,700 young breast cancer survivors from across the United States identified a desire for better communication about fertility issues, as well as a need for research into treatments that preserve fertility among young breast cancer survivors. Other research regarding fertility and preservation strategies is being conducted in conjunction with the Brigham and Women's Reproductive Endocrinology and Infertility program as well as in collaboration with both national and international colleagues.
The Empower Study
Shoshana Rosenberg, ScD, MPH, is the co-principal investigator of a multi-site study, sponsored in part by Dana-Farber, UMass Boston, and the Comprehensive Partnership to Advance Cancer Health Equity (CPACHE) (U54) Pilot Project Grant. The overall goal of this study is to qualitatively explore how behavioral, cultural, psychosocial, and economic barriers and facilitators affect the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer.
This study is closed to enrollment and is currently in data analysis.