Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Best Practice, Health Promotion and Education, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Lung Carcinoma. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Decision-Making Encounters in Lung Cancer (I DECide) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool
Overview
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.
Detailed description
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.
Interventions
- Other Best Practice
Receive standard of care - Other Health Promotion and Education
View decision aid - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Decision Conflict [Time frame: Up to 6 months]
- Efficacy of a conversation tool on patients' knowledge of lung cancer [Time frame: Up 6 months]
- Satisfaction with Communication/Confidence in Decision [Time frame: Up to 6 months]
- Self-Efficacy [Time frame: Up to 6 months]
Secondary outcome measures (8)
- FACT-L [Time frame: Up to 6 months.]
- Depression/Anxiety [Time frame: Up to 6 months]
- Participation in Decision-Making [Time frame: Up to 6 months]
- Decision Regret [Time frame: Up to 6 months]
- Quality of Communication [Time frame: Up to 6 months]
- Number of Palliative Care Referrals [Time frame: Up to 6 months]
- Treatment Decision-Making Concordance [Time frame: Up to 6 months]
- Acceptability [Time frame: Up to 6 months]
Eligibility criteria
Inclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 4 centers
- Hillsboro Medical Center — Hillsboro
- Adventist Health Portland — Portland
- OHSU Knight Cancer Institute — Portland
- Portland VA Medical Center — Portland
Publications
- 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
Identifiers
NCT: NCT05407168 · STUDY00023160 · NCI-2021-09819 · STUDY00023160