Oral oncolytic agents are estimated to account for 25% to 35% of all cancer treatment therapies, and more new oral oncolytics are in development. With the increasing use of oral oncolytics, cancer patients now assume responsibility to self-administer oral agents in their home instead of receiving intermittent intravenous therapy in a supervised healthcare environment. Patients have reported a preference for oral oncolytics over intravenous therapy because of convenience and flexibility for timing and location of administration. As oncolytic agents usually have complex regimens, a low therapeutic index and narrow safety margins, and significant variations in toxicities by individuals, the paradigm shift in cancer treatment can pose huge challenges to patients and families in self-management of oral oncolytics and medication side effects. Patients often incorrectly believe that oral oncolytic agents have less toxicity than intravenous oncolytic agents, and this misbelief may delay their early identifying any signs of side effects and reporting adverse effects to clinicians. An emerging literature has raised concerns of patients’ non-adherence to oral oncolytics, self-administration safety, and their effects on treatment outcomes and patient quality of life. However, there is a lack of understanding of patients’ self-management of oral oncolytics and side effects, and relationships of self-management with oral oncolytics adherence. The oncology community has focused on cancer symptom management, but not patient self-management. Medication adherence research highlights patients’ compliance with medication administration, but self-management of medication side effects in relation to medication adherence has not been fully understood. This pilot study proposes a conceptual model to explore the complex relationships among side effects of oral oncolytic agents, self-management of side effects, and adherence to oral oncolytics. Also, it intends to lend insight into the feasibility of proposed methods, including the adaptation of self-management measures, such as Measures of Drug Self-Management (MeDS) and Self-Care Diary (SCD), for use in future research. The pilot study narrowly focuses on one oral oncolytic agent, capecitabine, and its use as monotherapy or in combination with other chemotherapeutical agents in the treatment of colorectal cancer (CRC) for two consecutive cycles. The modified SCD removed side effects that do not apply for capecitabine and added specific capecitabine side effects, including assessment of effectiveness of self-care activities. The specific aims of this pilot study are:

• Specific Aim #1: Assess the reliability and validity of the Measure of Drug Self-Management and the modified Self-Care Diary in CRC patients under oral oncolytic treatment.
• Specific Aim #2:Explore the complex relationships among side effects of oral oncolytics, self-management of oral oncolytics side effects, and adherence to oral oncolytics.
  • Examine the potential mediation effect of oral oncolytics side effects on the relationship between self-management of oral oncolytics side effects and adherence to oral oncolytics.
  • Examine the potential moderation effect of self-management of oral oncolytics side effects on the relationship between adherence of oral oncolytics and oral oncolytics side effects.
• Specific Aim #3: Test the feasibility of design and conduction of the methods.
  • Test the feasibility of recruitment and retention of colorectal cancer patient participants who are taking oral oncolytics in the study.
  • Test the feasibility of weekly telephone based data collection from colorectal cancer patient participants for two consecutive cycles of treatment.