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NCT Number: NCT04946279

Decision Aid for the Improvement of Decision-Making in Patients With Non-small Cell Lung Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Non-Small Cell Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stage I Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute, Portland, Oregon, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual/standard of care

Other names: standard of care, standard therapy

Informational intervention

Other

Receive conversation tool

Questionnaire Administration

Other

Ancillary studies - Baseline and follow-up questionnaires

Primary outcomes

  1. Feasibility of the conversation tool

    Time frame: At enrollment

    The number of patients enrolled divided by the number of patients offered enrollment.

  2. Acceptability of the conversation tool

    Time frame: At enrollment

    The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool.

Secondary outcomes

  1. Anxiety

    Time frame: From enrollment to the end of follow-up at 8 weeks

    Assessed using the Hospital Anxiety and Depression Scale.

  2. Decisional conflict

    Time frame: At the end of follow-up at 8 weeks

    Assessed using the Decisional Conflict Scale.

  3. Decisional Regret

    Time frame: At the end of follow-up at 8 weeks

    Assessed using the Decisional Regret Scale.

  4. Perceived involvement in care

    Time frame: At the end of follow-up at 8 weeks

    Assessed using the Perceived Involvement in Care Scale.

  5. Shared decision-making quality

    Time frame: At the end of follow-up at 8 weeks

    Assessed using the Shared Decision Making Questionnaire.

  6. Decision making involvement

    Time frame: From enrollment to the end of follow-up at 8 weeks

    Assessed using the Control Preferences Scale.

  7. Self-efficacy

    Time frame: From enrollment to the end of follow-up at 8 weeks

    Assessed using the Decision Self-Efficacy Scale.

  8. Values-treatment concordance

    Time frame: From enrollment to the end of follow-up at 8 weeks

    Assessed using electronic medical record (EMR).

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • ATS Foundation
  • Hildegard Lamfrom Endowment
  • Medical Research Foundation, Oregon
  • Oregon Health and Science University

Registry information

Official study title

Improving Decision-Making Encounters in Lung Cancer (I DECide): A Low-Literacy Conversation Tool

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2021
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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