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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive usual care

  • Informational Intervention

    Other intervention

    Receive QOL fact sheet

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Group A (QOL fact sheet)Experimental treatment 2 interventions
Group B: Group B (usual care)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 6 months

Secondary outcomes

1

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.

Time frame
Up to 6 months
2

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.

Time frame
Up to 6 months
3

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.

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

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Roswell Park Cancer Institute

Lead sponsor

National Comprehensive Cancer Network

Collaborator