Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool

Официальное название

Improving Decision-Making Encounters in Lung Cancer (I DECide) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool

Обзор

This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.

Подробное описание

PRIMARY OBJECTIVES:

I. Conduct a randomized, controlled trial evaluating the efficacy of a conversation tool on patient-centered health and decision-making outcomes among patients making lung cancer treatment decisions. A subset of participants from control and intervention groups will also have their clinic conversations with providers recorded II. Conduct in-depth, semi-structured qualitative audio or video recorded interviews among a subset of Aim 1 participants.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients review decision aid.

GROUP II: Patients receive standard of care.

After completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months.

Вмешательства

• Другое Best Practice
  Receive standard of care
• Другое Health Promotion and Education
  View decision aid
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Decision Conflict [Срок оценки: Up to 6 months]
• Efficacy of a conversation tool on patients' knowledge of lung cancer [Срок оценки: Up 6 months]
• Satisfaction with Communication/Confidence in Decision [Срок оценки: Up to 6 months]
• Self-Efficacy [Срок оценки: Up to 6 months]

Вторичные конечные точки (8)

• FACT-L [Срок оценки: Up to 6 months.]
• Depression/Anxiety [Срок оценки: Up to 6 months]
• Participation in Decision-Making [Срок оценки: Up to 6 months]
• Decision Regret [Срок оценки: Up to 6 months]
• Quality of Communication [Срок оценки: Up to 6 months]
• Number of Palliative Care Referrals [Срок оценки: Up to 6 months]
• Treatment Decision-Making Concordance [Срок оценки: Up to 6 months]
• Acceptability [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• AIM 1: Suspected lung cancer
• AIM 1: English fluency
• AIM 1: > 6-month life expectancy
• AIM 1: Score of ≥ 3 on the cognitive impairment screener
• AIM 2 PARTICIPANTS: Participation in Aim 1
• AIM 2 CLINICIANS: Discussing lung cancer treatment decisions with Aim 1 participants

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

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 4 центра

• Hillsboro Medical Center — Hillsboro
• Adventist Health Portland — Portland
• OHSU Knight Cancer Institute — Portland
• Portland VA Medical Center — Portland

Публикации

• Disher N, Dieckmann NF, Case JR, Rubim F, Eden KB, Golden SE, Matlock DD, Coleman C, Lyons KS, Saha S, Slatore CG, Vranas KC, Sullivan DR. Improving lung cancer decision-making using a conversation tool (iDECIDE): a stepped wedge pragmatic clinical trial. Future Oncol. 2025 Apr;21(9):1045-1056. doi: 10.1080/14796694.2025.2475733. Epub 2025 Mar 18. PMID 40098532

Идентификаторы

NCT: NCT05407168 · STUDY00023160 · NCI-2021-09819 · STUDY00023160

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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