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RecruitingNot ApplicableNCT05292521

Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer

Utilizing Patient Reported Quality of Life to Inform Patient Decision Making in Early-Stage Lung Cancer

Sponsor

Roswell Park Cancer Institute

Enrollment

150 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8Stage IA3 Lung Cancer AJCC v8Stage IA1 Lung Cancer AJCC v8Stage IB Lung Cancer AJCC v8Stage IIA Lung Cancer AJCC v8

Summary

This clinical trial studies the effect of a quality of life intervention on decision-making in patients with early-stage lung cancer who are undergoing standard of care surgery or stereotactic body radiation therapy (SBRT). Providing quality of life outcome data to patients deciding between surgery and SBRT may help decrease decision regret and increase patient satisfaction with their care.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Age \>= 18 years
  • Radiographic stage I-II non-small cell lung cancer (NSCLC)
  • Of note, separate tumor nodule(s) in an ipsilateral lobe different from that of the primary is considered T4 disease. However, these are treated as separate stage I or II lesions and will be eligible for this study.
  • Eligible for both surgery and SBRT
  • Able to provide informed consent in English
  • Have verbal fluency in English
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria9

  • Radiographic stage III-IV NSCLC except as noted above
  • Eligible for either only surgery or SBRT, but not both
  • Eligible for palliative-intent treatments or supportive care only.
  • Pregnant female participants.
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate
  • Cognitively impaired adults/adults with impaired decision-making capacity
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners

Interventions

OTHERBest Practice

Receive usual care

OTHERInformational Intervention

Receive QOL fact sheet

OTHERQuestionnaire Administration

Ancillary studies

Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT05292521

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