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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
98
Receive usual/standard of care
Receive conversation tool
Ancillary studies - Baseline and follow-up questionnaires
OHSU Knight Cancer Institute
Portland, Oregon, United States
Portland VA Medical Center
Portland, Oregon, United States
Feasibility of the conversation tool
The number of patients enrolled divided by the number of patients offered enrollment.
Time frame: At enrollment
Acceptability of the conversation tool
The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool.
Time frame: At enrollment
Anxiety
Assessed using the Hospital Anxiety and Depression Scale.
Time frame: From enrollment to the end of follow-up at 8 weeks
Decisional conflict
Assessed using the Decisional Conflict Scale.
Time frame: At the end of follow-up at 8 weeks
Decisional Regret
Assessed using the Decisional Regret Scale.
Time frame: At the end of follow-up at 8 weeks
Perceived involvement in care
Assessed using the Perceived Involvement in Care Scale.
Time frame: At the end of follow-up at 8 weeks
Shared decision-making quality
Assessed using the Shared Decision Making Questionnaire.
Time frame: At the end of follow-up at 8 weeks
Decision making involvement
Assessed using the Control Preferences Scale.
Time frame: From enrollment to the end of follow-up at 8 weeks
Self-efficacy
Assessed using the Decision Self-Efficacy Scale.
Time frame: From enrollment to the end of follow-up at 8 weeks
Values-treatment concordance
Assessed using electronic medical record (EMR).
Time frame: From enrollment to the end of follow-up at 8 weeks
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