Tailored Intervention Protocol for Oral Chemotherapy Adherence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00932490
First received: July 2, 2009
Last updated: July 14, 2014
Last verified: November 2012

July 2, 2009
July 14, 2014
August 2009
February 2012   (final data collection date for primary outcome measure)
Adherence to Oral Chemotherapy Medication [ Time Frame: 2, 4, & 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00932490 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tailored Intervention Protocol for Oral Chemotherapy Adherence
Tailored Intervention Protocol for Oral Chemotherapy Adherence

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Cancer
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
  • Experimental: Nurse Coaching
    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
    Intervention: Behavioral: Nurse Coaching
  • No Intervention: Control
Schneider SM, Hess K, Gosselin T. Interventions to promote adherence with oral agents. Semin Oncol Nurs. 2011 May;27(2):133-41. doi: 10.1016/j.soncn.2011.02.005. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932490
Pro00015563, 1R15-CA-139398-01, 3031779
Yes
Duke University
Duke University
National Cancer Institute (NCI)
Principal Investigator: Susan M Schneider, PhD Duke University
Duke University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP