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

18 Years
Not Enrolling
Lung Cancer

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Trial Information

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

- 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

- 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.

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

- Not participating in other studies involving nurse/patient interactions

Type of Study:


Study Design:

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

Outcome Measure:

Feasibility of a DCN educational intervention to enhance participant knowledge

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Joan Lucca, RN, MSN, NP-C, AOCN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

February 2012

Related Keywords:

  • Lung Cancer
  • erlotinib
  • educational intervention
  • direct care nurse
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms