Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
Conditions
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.
Interventions
OTHERBest Practice
Receive usual/standard of care
OTHERInformational Intervention
Receive conversation tool
OTHERQuestionnaire Administration
Ancillary studies - Baseline and follow-up questionnaires
Sponsors
Oregon Health and Science University
ATS Foundation
Hildegard Lamfrom Endowment
Medical Research Foundation, Oregon
OHSU Knight Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the conversation tool | At enrollment | The number of patients enrolled divided by the number of patients offered enrollment. |
| Acceptability of the conversation tool | At enrollment | The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared decision-making quality | At the end of follow-up at 8 weeks | Assessed using the Shared Decision Making Questionnaire. |
| Anxiety | From enrollment to the end of follow-up at 8 weeks | Assessed using the Hospital Anxiety and Depression Scale. |
| Decisional conflict | At the end of follow-up at 8 weeks | Assessed using the Decisional Conflict Scale. |
| Decisional Regret | At the end of follow-up at 8 weeks | Assessed using the Decisional Regret Scale. |
| Self-efficacy | From enrollment to the end of follow-up at 8 weeks | Assessed using the Decision Self-Efficacy Scale. |
| Values-treatment concordance | From enrollment to the end of follow-up at 8 weeks | Assessed using electronic medical record (EMR). |
| Decision making involvement | From enrollment to the end of follow-up at 8 weeks | Assessed using the Control Preferences Scale. |
| Perceived involvement in care | At the end of follow-up at 8 weeks | Assessed using the Perceived Involvement in Care Scale. |
Countries
United States
Outcome results
None listed