Lung Non-Small Cell CarcinomaNCT05292521
Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer
A study testing Best Practice, Informational Intervention and Questionnaire Administration in people with Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8
- What is being tested?
- Best Practice, Informational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2023to 21 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Cognitively impaired adults/adults with impaired decision-making capacity
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Anurag K. Singh, 716-845-1179, Anurag.Singh@RoswellPark.org
Anurag K. Singh
About this study
Official title: Utilizing Patient Reported Quality of Life to Inform Patient Decision Making in Early-Stage Lung Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Being tested
- Best Practice, Informational Intervention, Questionnaire Administration
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Informational InterventionOther
Receive QOL fact sheet
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group A (QOL fact sheet) | Experimental | 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). Receives: Other: Informational Intervention; Other: Questionnaire Administration |
| Group B (usual care) | Active comparator | Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision regret
Compare the extent of decision regret based on Decision Regret Scale between the provision of quality of life (QOL) information versus usual care for standard of care surgery or stereotactic body radiation therapy (SBRT) treatment. The five-point decision regret score will be converted to a 100-point score as described by others, where a higher score reflects an increased decision regret. In this schema, a decision regret score > 25 % is deemed moderate to severe regret. The dichotomized decision regret will be modeled as a function of group, time, and their interaction using a generalized estimating equations (GEE) logistic regression model with an autoregressive covariance structure. The rates of less than moderate to severe regret will be compared between groups at 6-months using a one-sided test about the appropriate contrast of model estimates.
Measured: At 6 months
Secondary outcomes (3)
Quality of Life (EORTC QLQ-C30)
Will compare QOL measures based on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) between the provision of QOL information versus usual care for standard of care surgery or SBRT treatment.
Measured: Up to 6 months
Quality of Life (QOL)
Will compare QOL measures based on the lung cancer- specific questionnaire (EORTC QLQ-LC13) between the provision of QOL information versus usual care for standard of care surgery or SBRT treatment.
Measured: Up to 6 months
Difference in consideration of regret
Compare decisions about treatment for early stage lung cancer and examined whether regret is a consideration in treatment decisions between those who received the quality of life fact sheet and those who did not.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start21 Dec 2023
- Primary completion21 Dec 2028 (estimated)
- Study completion21 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Anurag K Singh, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292521
- Sponsor's protocol ID
- I 2220321
- Other IDs
- NCI-2022-01257, I 2220321
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No