Improving decision-making for early-stage lung cancer patients
Utilizing Patient Reported Quality of Life to Inform Patient Decision Making in Early-Stage Lung Cancer
NA · Roswell Park Cancer Institute · NCT05292521
This study is testing whether giving early-stage lung cancer patients a quality of life fact sheet during their treatment decision-making helps them feel better about their choices compared to usual care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT05292521 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of a quality of life intervention on decision-making for patients with early-stage lung cancer who are considering standard treatment options such as surgery or stereotactic body radiation therapy (SBRT). Participants are randomly assigned to receive either a quality of life fact sheet or usual care during their initial consultation. The study aims to assess how this information affects decision regret and overall quality of life. Follow-up assessments are conducted at 1, 3, and 6 months post-treatment to gather data on patient satisfaction and outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage I-II non-small cell lung cancer who are eligible for both surgery and SBRT.
Not a fit: Patients with advanced stage lung cancer (stage III-IV) or those eligible for only one treatment option may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance patient satisfaction and reduce decision regret for those facing treatment choices in early-stage lung cancer.
How similar studies have performed: Similar studies have shown that providing quality of life information can positively influence patient decision-making and satisfaction, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Anurag K Singh — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8