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Tailored Intervention Protocol for Oral Chemotherapy Adherence

18 Years
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Trial Information

Tailored Intervention Protocol for Oral Chemotherapy Adherence

While cancer patients express a preference for oral medications, compliance to these
medications varies. 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 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. 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), which provide a unified approach to
longitudinal modeling techniques for normally and non-normally distributed outcome

Inclusion Criteria:

- a diagnosis of Breast, Colorectal, GIST, Renal, HPCC, Myeloma and Chronic Leukemia

- 18 years or older

- a treatment regimen that includes at least one oral chemotherapeutic agent

- ability to read and write English

- ability to give informed consent

- ability to have prescriptions for oral chemotherapy filled at the Duke University
Medical Center pharmacy

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Adherence to Oral Chemotherapy Medication

Outcome Time Frame:

2, 4, & 6 months

Safety Issue:


Principal Investigator

Susan M Schneider, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

February 2012

Related Keywords:

  • Cancer



Duke University Medical CenterDurham, North Carolina  27710