Tailored Intervention Protocol for Oral Chemotherapy Adherence

Study Overview
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Brief Summary
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The primary aim of study is to: Test the effectiveness of a tailored protocol in promoting adherence to oral chemotherapeutic agents in adults receiving a new oral chemotherapeutic agent for breast, colorectal, GIST, renal cell,and hepatocellular cancers. Exploratory Aims: Examine adherence to oral chemotherapeutic agents over time at 2, 4 and 6 months in a sample of breast, colorectal, GIST, renal cell,and HPCC cancers patients. Examine the effects of age, gender, caregiver availability, personal involvement in health care, and depression on adherence to oral chemotherapeutic agents.

Detailed Description
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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 variables.

Official Title
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Tailored Intervention Protocol for Oral Chemotherapy Adherence

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Nurse Coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse Coaching<br>Tailored adherence intervention that will be based on the particular needs of patients and an advanced practice nurse will suggest individualized strategies to overcome barriers to adherence | Behavioral: Nurse Coaching<br>* Tailored adherence intervention that will be based on the particular needs of patients and advanced practice nurses will suggest individualized strategies to overcome barriers to adherence<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Oral Chemotherapy Medication |  | 2, 4, & 6 months |