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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Decision regret [Срок оценки: At 6 months]

Вторичные конечные точки (3)

• Quality of Life (EORTC QLQ-C30) [Срок оценки: Up to 6 months]
• Quality of Life (QOL) [Срок оценки: Up to 6 months]
• Difference in consideration of regret [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Roswell Park Cancer Institute — Buffalo

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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