Patient Centered Randomized Controlled Trial

Numerous trials proved the efficacy of radiation following breast conserving surgery and
systemic therapies to increase disease-free and overall survival among women with
early-stage breast cancer. Yet 14%-89% of women do not receive them, especially minority
women. Despite lower incidence of the disease, African American women are more likely than
white women to die of breast cancer. As we near racial equity in rates of breast cancer
screening, disparities in treatment and mortality remain. Efforts to achieve control of
breast cancer and reduce racial disparities in mortality will not be fully realized until
proven effective treatments are provided to those who can benefit.

Underuse of effective treatments may be caused by patient, physician and system factors.
For breast cancer screening, women's lack of access to care; insurance; transportation;
beliefs about fatalism and curability, and cancer's effect on partner relationships, all
impact mammography rates. For breast cancer treatment, little is known about
patient-related reasons for underuse, and less is known about racial differences in such
reasons.

Interventions targeted to specific causes are more likely to succeed. For breast cancer
screening, patient-centered interventions that successfully raise mammography rates among
minority women include lay health workers to raise awareness about and address cultural
beliefs and barriers to screening, vouchers to pay for screening and navigators to help
women with abnormal screenings obtain needed follow-up. For breast cancer treatment,
patient-assistance programs provide practical support such as financial counseling, aid with
navigating the complex healthcare system, emotional support, and information about cancer
and its treatment. Such programs abound but patients are often unaware of them. While
these services may increase the receipt of effective adjuvant therapies, these strategies
have not been rigorously tested.

We propose to conduct a randomized controlled trial to evaluate the effectiveness of
patient-assistance programs as compared with usual care on receipt of adjuvant therapies
among minority and nonminority women with newly operated early-stage breast cancer. During
the 24 month trial, we will assess patients' beliefs about cancer and its treatment, and
their practical, psychosocial, and informational needs and barriers to care. We will
identify and train employees in existing cancer assistance services in order to increase the
sustainability of this program beyond the grant-funded cycle. Specifically, we propose:

1. To assess racial differences in early-stage breast cancer patients' experiences,
beliefs about and barriers to effective adjuvant treatments;

2. To evaluate the effectiveness of an intervention connecting women with early-stage
breast cancer and cancer-related needs to community and hospital-based
patient-assistance programs to reduce underuse of effective adjuvant breast cancer
treatment overall and in minority populations and to assess its sustainability; and

3. To evaluate whether this patient assistance intervention affects patients' knowledge,
attitudes and behaviors