Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer: A Feasibility Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378598
• Other study ID #: 10-171
• Status: Completed
• Phase: N/A
• First received: December 27, 2010
• Last updated: June 22, 2012
• Start date: September 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Research has found that patients sometimes have trouble obtaining oral (by mouth) cancer medications, understanding how to take these pills, handling side effects related to these drugs, and remembering to take these medications. The purpose of this research study is to have direct care nurses (DCNs) in the Thoracic Oncology Program (TOP) clinic provide teaching and follow-up to patients starting erlotinib (using a teaching tool) and to test the feasibility of providing education and follow-up. This study will also evaluate if increasing knowledge about erlotinib helps participants manage side effects and stay on their erlotinib without interruptions.

Description:

• Participants with non-small cell lung cancer will be asked to join this study after they have decided with their health care provider to start treatment with erlotinib (a pill).

• Educational Session 1 (Day that erlotinib is prescribed): During this clinic visit the physician or nurse practitioner will provide the participant with the DFCI Erlotinib Fact Sheet that reviews how to take the oral cancer medication and possible side effects to watch for. The TOP nurse will discuss the study and consent the participant. The TOP nurse will also provide participants with an Erlotinib Drug Log and instruct them on how use it to keep track of taking the erlotinib.

• Educational Session 2 (Within 72 hours of starting erlotinib): During this educational session, participants will talk with the TOP nurse by phone or in the clinic. The TOP nurse will use an oral cancer medication teaching tool (MOATT - Parts 1-4) to provide additional education about erlotinib. The MOATT tool was developed by the Multinational Association for Supportive Care in Cancer. This session will take about 20-30 minutes. Feasibility information will also be recorded by the nurse.

• Educational Session 3 (Phone follow-up 72 hours after Session 2): During this phone session, the TOP nurse will administer Parts 3-4 of the MOATT and discuss any side effects the participant is experiencing. This session will take 15-30 minutes. Feasibility information will also be documented.

• Educational Session 4 (First clinic visit after starting on Erlotinib): The TOP nurse will meet with the participant during their first DFCI clinic visit (with their physician or nurse practitioner), after starting erlotinib. During this session the participant will complete the Morisky Medication Adherence Scale 8-Item (MMAS-8), a Knowledge Rating Scale, and a demographic form. Parts 3-4 of the MOATT will also be administered, the Erlotinib Drug Log will be collected, and side effects will be discussed/recorded. This meeting will add 30-40 minutes to the clinic visit.

• After the participant completes Educational Session 4, their participation in the study will end.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• 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:

• 18 years of age or older

• Non-small cell lung cancer diagnosis

• Patient/provider decision to start erlotinib monotherapy

• No prior treatment with erlotinib

• Willingness to follow the protocol visit schedule

• Ability to understand and converse in English

• No major physical or psychological limitation that would interfere with study participation

• Not participating in other studies involving nurse/patient interactions

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Nursing Educational Intervention
Four educational sessions with the direct care nurse (DCN)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a DCN educational intervention to enhance participant knowledge	To test the feasibility of direct care nurse (DCN) educational intervention to enhance participant knowledge of erlotinib and improve patient-reported adherence with regard to: 1) enrollment and retention rates, 2) DCN availability, 3) Completion of educational sessions and 4) Resources used or required for each session	1 year	No
Secondary	Describe the knowledge of and adherence to erlotinib as an oral anticancer agent	To describe the knowledge of (by MOATT) and adherence to (by MMAS 8-item) erlotinib as an oral anticancer agent in thoracic oncology patients.	1 year	No