Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nursing Educational Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring erlotinib, educational intervention, direct care nurse
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01378598
First Posted
December 27, 2010
Last Updated
June 22, 2012
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01378598
Brief Title
Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer
Official Title
Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer: A Feasibility Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
erlotinib, educational intervention, direct care nurse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Nursing Educational Intervention
Intervention Description
Four educational sessions with the direct care nurse (DCN)
Primary Outcome Measure Information:
Title
Feasibility of a DCN educational intervention to enhance participant knowledge
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Describe the knowledge of and adherence to erlotinib as an oral anticancer agent
Description
To describe the knowledge of (by MOATT) and adherence to (by MMAS 8-item) erlotinib as an oral anticancer agent in thoracic oncology patients.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Lucca, RN, MSN, NP-C, AOCN
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer
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