Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Sep 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 27, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJune 26, 2012
June 1, 2012
1.4 years
December 27, 2010
June 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Describe the knowledge of and adherence to erlotinib as an oral anticancer agent
1 year
Interventions
Four educational sessions with the direct care nurse (DCN)
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan Lucca, RN, MSN, NP-C, AOCN
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 27, 2010
First Posted
June 22, 2011
Study Start
September 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
June 26, 2012
Record last verified: 2012-06