Patient’s Anastrozole Compliance to Therapy Programme (PACT): Influence of the addition of a standardized information and reminder service on compliance in comparison to standard clinical care alone in women with early-stage breast cancer

Abstract

11582 Background: An important requirement for the effectiveness of any therapeutic intervention is optimal compliance. In the adjuvant treatment of hormone responsive breast cancer, existing data document that 23% and 50% of patients were non-compliant after the first and fourth year of tamoxifen (TAM) therapy. To date, no data on compliance to aromatase inhibitors (AI) outside of randomized clinical trials (RCTs) has been reported. Methods: PACT programme has a two arm, randomized, parallel group design with a primary duration of 12 months and observation extended to 60 months. From July 2006 to September 2008, we intend to enroll 4,674 postmenopausal, receptor positive breast cancer patients assigned to adjuvant AI therapy in accordance with standard local practice and independent of participation in the programme. After written informed consent, patients will be randomized to a standardized information and reminder service or to routine clinical care alone. Compliance will be evaluated by self report using standardized, detailed questionnaires at baseline and after each year of treatment. In addition, we will collect the prescription data for each patient from hospital records and physician recall. Finally, we will assess quality of life and patient’s satisfaction using standardized questionnaires. Secondary endpoints include persistence on therapy, reasons for non- compliance, influence of baseline characteristics on compliance as well as the influence of compliance on clinical outcome parameters. Conclusions: An important goal of any therapeutic intervention is to achieve comparable efficacy in routine clinical practice to that demonstrated in RCTs. The aim of the PACT programme is to evaluate whether a simple intervention such as a standardized information and reminder service can lead to a significant increase in compliance in women with primary breast cancer. If successful, such simple measures could greatly improve the efficacy of adjuvant endocrine treatment and would thus have significant impact on individual patient outcomes as well as the health care system. No significant financial relationships to disclose.