Tailored Intervention Protocol for Oral Chemotherapy Adherence

Cancer Clinical Trial

Official title:

Tailored Intervention Protocol for Oral Chemotherapy Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932490
• Other study ID #: Pro00015563
• Secondary ID: 1R15CA139398-013
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: July 14, 2014
• Start date: August 2009
• Est. completion date: February 2012

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Oral Chemotherapy Medication		2, 4, & 6 months	No