NCT01378598

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2010

Status
completed

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

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2010

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1.4 years

First QC Date

December 27, 2010

Last Update Submit

June 22, 2012

Conditions

Keywords

erlotinibeducational interventiondirect care nurse

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Joan Lucca, RN, MSN, NP-C, AOCN

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

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