Grant R15CA139398

Tailored Intervention Protocol for Oral Chemotherapy Adherence

DESCRIPTION (provided by applicant): Oral chemotherapy is prescribed to diminish tumor mass, eradicate micrometastatic disease, and increase disease-free survival in cancer patients. While cancer patients express a preference for oral medications, compliance to these medications varies. Patients often have difficulty adhering to the prescribed schedule because of lack of understanding, inadequate support, or treatment related side effects. Patients who successfully adhere to chemotherapy regimens have a greater chance of non-recurrence and long-term quality of life. Thus, helping patients tolerate oral chemotherapy regimens is critical to their survival. The aims of this study are to 1) test the effectiveness of a tailored protocol to promote adherence to oral chemotherapeutic agents in adults receiving treatment for breast or colorectal cancer, 2) examine adherence to oral chemotherapeutic agents over time, and 3) examine the effects of age, gender, caregiver availability, personal involvement in health care, and depression on adherence rates to oral chemotherapeutic agents. The tailored adherence protocol is based on the self-regulatory model of adherence. The intervention identifies patient knowledge, behavioral skills, and affective support and tailors adherence strategies or overcomes barriers in each of these three categories. A randomized clinical trial will examine the adherence rates in a 150 adults started on a new oral chemotherapeutic agent at Duke University Medical Center. A control group will receive standard chemotherapy education. Participants in the experimental group will receive the standard education, an assessment and the tailored intervention developed by an advanced practice nurse. The intervention will be administered via telephone calls over six months. Patient adherence rates will be measured in both groups at 2, 4 and 6 months using self report, symptom profiles, and pharmacy fill rates. To determine the effectiveness of the adherence protocol, we will use Generalized Estimating Equations (with SAS Genmod), which provide a unified approach to longitudinal modeling techniques for normally and non-normally distributed outcome variables. Public Health Relevance: Lack of knowledge or skill and medication side effects are major reasons why cancer patients do not adhere to cancer treatments. Nursing interventions designed to promote adherence can help to enhance chances for cure and improve patient quality of life. This proposal tests the effectiveness of a theoretically based intervention to help individuals adhere to oral chemotherapy regimens.