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Recruiting NCT05292521

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

No phase Interventional Lung Non-Small Cell Carcinoma Stage I Lung Cancer AJCC v8 Stage IA1 Lung Cancer AJCC v8 Stage IA2 Lung Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Informational Intervention, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

PRIMARY OBJECTIVE:

I. Determine the effect of provision of quality-of-life (QOL) information versus usual care for standard of care surgery or SBRT treatment on decision regret.

SECONDARY OBJECTIVES:

I. Determine the effect of provision of QOL information versus usual care for standard of care surgery or SBRT treatment on QOL measures.

II. Determine the influence of socioeconomic status on the relationship between decision regret and QOL information associated with each treatment modality.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: Patients receive study QOL intervention fact sheet during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. Patients have an opportunity to review the QOL fact sheet in person and discuss any questions with the treating physician(s).

GROUP B: Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT.

Patients are followed up at 1, 3, and 6 months after standard of care surgery or SBRT.

Interventions

  • Other Best Practice
    Receive usual care
  • Other Informational Intervention
    Receive QOL fact sheet
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Decision regret [Time frame: At 6 months]
Secondary outcome measures (3)
  • Quality of Life (EORTC QLQ-C30) [Time frame: Up to 6 months]
  • Quality of Life (QOL) [Time frame: Up to 6 months]
  • Difference in consideration of regret [Time frame: Up to 6 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Roswell Park Cancer Institute — Buffalo

Identifiers

NCT: NCT05292521 · I 2220321 · NCI-2022-01257 · I 2220321

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗