A Trial Examining an Advanced Practice Nurse Intervention to Promote Medication Adherence and Symptom Management in Adult Cancer Patients Prescribed Oral Anti-Cancer Agents: Study Protocol

Aim: To report a study protocol that refines then examines feasibility, preliminary efficacy, and satisfaction of ADHERE, an intervention using motivational interviewing and brief cognitive behavioral therapy as a mechanism for goal-oriented systematic patient education to promote symptom management and adherence among cancer patients prescribed oral anti-cancer agents. Background: Cancer treatment with oral anti-cancer agents shifts responsibility for managing treatment from clinicians in supervised cancer centers to patients and their caregivers. Thus, a need exists to standardize start-of-care for support patient self-management of care at home. Design: A two-phase quasi-experimental sequential design with repeated measures. Methods: Sixty five adult patients newly prescribed an oral anti-cancer agent will be recruited from three community cancer centers. Phase one will enroll 5 patients to refine the ADHERE intervention prior to testing, using an iterative process. After completion, Phase two will enroll 30 patients who receive usual care to examine symptoms and ahderence. Advanced practice nurses will then be trained. Then 30 patients will be enrolled in the intervention group and provided ADHERE, a 4-week intervention using semi-structured interactions (initial face-to-face session and once a week phone sessions over 3-weeks) and a Toolkit to promote self-management of care. Outcome measures include: oral anti-cancer agents adherence rate, symptom presence and severity, feasibility, and satisfaction with ADHERE. This protocol was approved January 2014 and is registered at ClinicalTrials.gov (Identifier NCT02337296). Discussion: This nurse-led intervention has the potential to standardize the start-of-care training for the patients to self-manage when prescribed oral anti-cancer agents for treatment