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Tailored Intervention Protocol for Oral Chemotherapy Adherence
This study is not yet open for participant recruitment.
Verified by Duke University, July 2009
First Received: July 2, 2009   Last Updated: July 6, 2009   History of Changes
Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00932490
  Purpose

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 or colorectal cancer.

    Exploratory Aims:

  2. Examine adherence to oral chemotherapeutic agents over time at 2, 4 and 6 months in a sample of breast and colorectal patients.
  3. Examine the effects of age, gender, caregiver availability, personal involvement in health care, and depression on adherence to oral chemotherapeutic agents.

Condition Intervention
Cancer
Behavioral: Nurse Coaching

Study Type: Interventional
Study Design: Supportive Care, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title: Tailored Intervention Protocol for Oral Chemotherapy Adherence

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Adherence to Oral Chemotherapy Medication [ Time Frame: 2, 4, & 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nurse Coaching: Experimental
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
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
Control: No Intervention

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 breast or colorectal 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 Genmod), which provide a unified approach to longitudinal modeling techniques for normally and non-normally distributed outcome variables.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a diagnosis of breast or colorectal cancer
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932490

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University Medical Center ( Susan M. Schneider )
Study ID Numbers: 3031779, 1R15-CA-139398-01
Study First Received: July 2, 2009
Last Updated: July 6, 2009
ClinicalTrials.gov Identifier: NCT00932490     History of Changes
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 10, 2009