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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joan Lucca, RN, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01378598
First received: December 27, 2010
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Lung Cancer
Other: Nursing Educational Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer: A Feasibility Pilot Study

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Feasibility of a DCN educational intervention to enhance participant knowledge [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Describe the knowledge of and adherence to erlotinib as an oral anticancer agent [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To describe the knowledge of (by MOATT) and adherence to (by MMAS 8-item) erlotinib as an oral anticancer agent in thoracic oncology patients.


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Nursing Educational Intervention
    Four educational sessions with the direct care nurse (DCN)
Detailed 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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378598

Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Joan Lucca, RN, MSN, NP-C, AOCN Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Joan Lucca, RN, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01378598     History of Changes
Other Study ID Numbers: 10-171
Study First Received: December 27, 2010
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
erlotinib
educational intervention
direct care nurse

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014