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Clinical Trials/NCT00932490
NCT00932490
Completed
Not Applicable

Tailored Intervention Protocol for Oral Chemotherapy Adherence

Duke University1 site in 1 country48 target enrollmentAugust 2009
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Duke University
Enrollment
48
Locations
1
Primary Endpoint
Adherence to Oral Chemotherapy Medication
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The primary aim of study is to:

  1. 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:

  2. 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.

  3. Examine the effects of age, gender, caregiver availability, personal involvement in health care, and depression on adherence to oral chemotherapeutic agents.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
February 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Adherence to Oral Chemotherapy Medication

Time Frame: 2, 4, & 6 months

Study Sites (1)

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