Lung CancerNCT01378598
Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer
A study testing Nursing Educational Intervention in people with Lung Cancer, run by Dana-Farber Cancer Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nursing Educational Intervention
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer: A Feasibility Pilot Study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Nursing Educational Intervention
- Keywords
- erlotinib, educational intervention, direct care nurse
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Educational InterventionOther
Four educational sessions with the direct care nurse (DCN)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Lucca, RN, Dana-Farber Cancer Institute
- Investigators
- Joan Lucca, RN, MSN, NP-C, AOCN, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378598
- Sponsor's protocol ID
- 10-171
- Status last verified
- Jun 2012
- First submitted
- 27 Dec 2010
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT01378598
- Acronym / sponsor ID
- 10-171
- Conditions
- Lung Cancer
- Keywords
- erlotinib, educational intervention, direct care nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Educational InterventionFour educational sessions with the direct care nurse (DCN) | Other | – |
Primary outcome
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
1 secondary outcome
Describe the knowledge of and adherence to erlotinib as an oral anticancer agent
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Lucca, RN, MSN, NP-C, AOCN principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Educational Intervention in people with Lung Cancer, run by Dana-Farber Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a DCN educational intervention to enhance participant knowledge (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.