RecruitingNot ApplicableNCT03199651

Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer

Beating Lung Cancer in Ohio (BLCIO) Protocol


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

3,584 participants

Start Date

Jul 17, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized clinical trial studies the Beating Lung Cancer in Ohio protocol in improving survival in patients with stage IV non-small cell lung cancer. The Beating Lung Cancer in Ohio protocol may help in evaluating immunotherapies and targeted therapies that prolong survival, have more favorable toxicity profiles than conventional chemotherapy and impact quality of life.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • AIM 1-3
  • Pathologically confirmed stage IV NSCLC (with any Eastern Cooperative Oncology Group \[ECOG\] performance status, and any NSCLC - adenocarcinoma, squamous cell, etc.) with available imaging OR patients who do not yet have their staging completed, but in the judgment of the physician are likely to be stage IV;
  • Patients may be enrolled if the recruiter cannot reach the patient by the first office visit, preferably prior to starting therapy and no later than one month after starting therapy; (NCCN guidelines allow for a switch to targeted therapy from chemotherapy if testing comes back positive after starting chemotherapy)
  • English speaking; and
  • Willing to provide access to medical records, insurance and billing data, biospecimens and respond to questionnaires, typically by phone, but possibly to include online or in-person surveys
  • AIM 3 ONLY
  • Patients must be current smokers who smoke at least one cigarette most days per week, or recent quitters who smoked at least one cigarette most days per week (\< 3 months); and
  • Household members must be current smokers, defined as smoking at least one cigarette most days per week
  • Hearing and vision impairments that would prevent ability to complete consent, interviews, or sample collection

Exclusion Criteria2

  • Being treated with definitive chemoradiotherapy or surgery
  • Receiving treatment for advanced lung cancer for over one month before enrollment; OR

Interventions

OTHERBest Practice

Receive usual care

PROCEDUREBiospecimen Collection

Undergo collection of tumor tissue and blood sample for repository

PROCEDUREBiospecimen Collection

Undergo tumor tissue and blood sample for AGIT/DS

OTHERLaboratory Biomarker Analysis

Correlative studies

OTHERMedical Chart Review

Undergo medical record abstraction

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

BEHAVIORALSmoking Cessation Intervention

Undergo usual care or NCCN-driven CTC/DS


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT03199651


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