Clinical trial NCT04946279: Decision Aid for the Improvement of Decision-Making in Patients With Non-small Cell Lung Cancer
Official title: Improving Decision-Making Encounters in Lung Cancer (I DECide): A Low-Literacy Conversation Tool
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Non-Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: ATS Foundation
name: Hildegard Lamfrom Endowment
name: Medical Research Foundation, Oregon
First posted: 2021-06-30
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process.

II. Conduct a trial at two comprehensive cancer treatment centers representing academic and Veterans Affairs medical centers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive the conversation tool.

ARM II: Patients receive usual care.

Patients in both arms are followed up within 4-8 weeks after baseline to complete a second questionnaire.

Eligibility criteria: Inclusion Criteria:

* PART I: Completed treatment for suspected or confirmed stage I-IV non-small cell lung cancer (NSCLC)
* PART I: English fluency
* PART II: Undergoing diagnostic work-up for suspected stage I-IV NSCLC
* PART II: English fluency
* PART II: \> 6-month life expectancy
* PART II: Score of \> 3 on the 6-Item Screener for Cognitive Impairment

Primary outcomes:
measure: Feasibility of the conversation tool
timeFrame: At enrollment
measure: Acceptability of the conversation tool
timeFrame: At enrollment
Secondary outcomes:
measure: Anxiety
timeFrame: From enrollment to the end of follow-up at 8 weeks
measure: Decisional conflict
timeFrame: At the end of follow-up at 8 weeks
measure: Decisional Regret
timeFrame: At the end of follow-up at 8 weeks
measure: Perceived involvement in care
timeFrame: At the end of follow-up at 8 weeks
measure: Shared decision-making quality
timeFrame: At the end of follow-up at 8 weeks
measure: Decision making involvement
timeFrame: From enrollment to the end of follow-up at 8 weeks
measure: Self-efficacy
timeFrame: From enrollment to the end of follow-up at 8 weeks
measure: Values-treatment concordance
timeFrame: From enrollment to the end of follow-up at 8 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Donald Sullivan
role: PRINCIPAL_INVESTIGATOR
References: