Treatment with endocrine therapy in combination with ovarian function suppression (OFS) for 5 years improves
disease-free survival in premenopausal women with hormone receptor positive breast cancer compared to
tamoxifen alone. However, there is a high rate of early treatment discontinuation, which can increase breast
cancer recurrence and mortality. Most patients who discontinue treatment prematurely do so because of
bothersome toxicities and decreased quality of life (QOL). Therefore, approaches are needed to improve
symptom management in young women at high risk of breast cancer recurrence.
Use of patient reported outcomes (PRO) improves patient-provider communication and patient satisfaction. In
advanced cancer, active symptom monitoring between clinic visits with a web-based tool improves health-related
QOL and increases overall survival. However, in early stage cancer there are limited if any data to support the
use of active symptom monitoring with PROs to impact disease outcomes.
The objectives of this R01 are to evaluate the effectiveness of active symptom monitoring on endocrine therapy
discontinuation, and to identify factors associated with benefit from this management approach. We hypothesize
that early identification of toxicity will change the symptom experience of patients, leading to increased
persistence with therapy. Therefore, we will apply the active symptom monitoring methodology to a diverse,
multiethnic cohort of premenopausal women with newly diagnosed high risk, early stage breast cancer. Our
proposed study will leverage the resources of the NCI Community Oncology Research Program (NCORP) and
the SWOG Cancer Research Network. Patients initiating treatment with endocrine therapy plus OFS will be
enrolled and randomized to proactive, web-based symptom assessment plus patient education versus patient
education alone. The following Specific Aims will be addressed: (1) to investigate the impact of active symptom
monitoring on 18-month persistence with endocrine therapy, (2) to examine the effect of active symptom
monitoring on severity of key treatment-emergent symptoms in premenopausal women with early stage breast
cancer, and (3) to develop a risk prediction model to identify patients at increased risk of ET nonpersistence who
are likely to benefit from active symptom monitoring. Through this series of Aims we expect to demonstrate the
effectiveness of active symptom monitoring on persistence with and tolerance of endocrine therapy in a cohort
of young women with breast cancer. In addition, we expect to obtain new knowledge that will provide important
preliminary data to support future interventional studies targeting reasons for nonpersistence with endocrine
therapy. Improving persistence with endocrine therapy and reducing treatment-associated toxicity will lead to
improved disease outcomes and quality of life for young breast cancer survivors.
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