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NCT Number: NCT05292521

Quality of Life Intervention 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.

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Key information

Conditions

Lung Non-Small Cell Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms 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 Stage IIB Lung Cancer AJCC v8 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Anurag K. Singh

CONTACT

[email protected]

716-845-1179

Anurag K. Singh

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Informational intervention

Other

Receive QOL fact sheet

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Decision regret

    Time frame: At 6 months

    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.

Secondary outcomes

  1. Quality of Life (EORTC QLQ-C30)

    Time frame: Up to 6 months

    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.

  2. Quality of Life (QOL)

    Time frame: Up to 6 months

    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.

  3. Difference in consideration of regret

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 23, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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