Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01378598|
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : June 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Other: Nursing Educational Intervention||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Other: Nursing Educational Intervention
- Feasibility of a DCN educational intervention to enhance participant knowledge [ Time Frame: 1 year ]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
- Describe the knowledge of and adherence to erlotinib as an oral anticancer agent [ Time Frame: 1 year ]To describe the knowledge of (by MOATT) and adherence to (by MMAS 8-item) erlotinib as an oral anticancer agent in thoracic oncology patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378598
|Principal Investigator:||Joan Lucca, RN, MSN, NP-C, AOCN||Dana-Farber Cancer Institute|