CompletedNot applicableNCT01924416
Official study title

Lung Cancer Information Study (LCIS-R01)

Study summary

The primary specific aim is to test the hypothesis that use of a decision aid to enhance informed, shared decision making coupled with quality of life assessment in patients with advanced lung cancer receiving first-, second-, or third-line therapy will lead to a reduction in two major contributors of cost (number of chemotherapy cycles; number of advanced imaging studies) compared with the control arm.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedEnhanced Care (intervention group and comparison group) and Usual care (routine chemotherapy cycles and imaging studies)

The study team can explain what participation involves.

Who it may be forNon-Small-Cell Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 19, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Virginia

Study sponsor

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Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
University of Virginia
Interventions being studied
Behavioral: Enhanced Care (intervention group and comparison group); Behavioral: Usual care (routine chemotherapy cycles and imaging studies)
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

A. for lung cancer subject: 1. Pathologically or cytologically determined non-small cell lung cancer (NSCLC) 2. Receiving either first-line, second-line, or third-line chemotherapy for advanced NSCLC. Any chemotherapy will be acceptable 3. Stage IIIB or IV 4. Performance status of KPS 60-100% or ECOG 0-2 5. Hematologic and metabolic parameters suitable for chemotherapy 6. Patients previously treated with adjuvant therapy who now have recurrent NSCLC, will be included as receiving first line therapy 7. Patients with brain metastasis are eligible provided: they are at least 1 week from completion of surgery or RT for brain metastasis, have stable and adequate neurological status to proceed with chemotherapy, and meet all other eligibility criteria 8. Patients with prior cancer diagnoses (with or without prior chemotherapy), are eligible provided the previous malignancy is well controlled 9. Ages greater than 18 with NSCLC 10. Life expectancy greater than three months 11. Able to understand English or Spanish, but is not required to be literate B.

Reasons someone may not be able to joinExclusion criteria

for lung cancer subject: 1. Patients treated with molecular targeted therapy as their sole treatment 2. Patients with documented severe psychiatric diagnoses from the medical record, which may prevent full study participation 3. Patients receiving protocol chemotherapy that mandates either the number of cycles of treatment to be received or a fixed schedule of imaging studies 4. Patients receiving concomitant chemotherapy and radiation therapy are not eligible for this protocol 5. Patients who are prisoners 6. Patients who are pregnant (self reporting by patient) 7. Patients who are cognitively impaired C. Inclusion criteria for supporter: 1. Ages greater than 18 2. Able to understand English or Spanish, but is not required to be literate D.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of VirginiaCharlottesville, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 19, 2018. Always confirm current availability with the study team.

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