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

NCT04946279 | Active Not Recruiting

• 2 other identifiers: STUDY00020688NCI-2021-05887
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of the conversation tool

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

  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.

  At enrollment

Secondary Outcomes (8)

• Anxiety

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

• Decisional conflict

  At the end of follow-up at 8 weeks

• Decisional Regret

  At the end of follow-up at 8 weeks

• Perceived involvement in care

  At the end of follow-up at 8 weeks

• Shared decision-making quality

  At the end of follow-up at 8 weeks

Study Arms (2)

Arm I (conversation tool)

EXPERIMENTAL

Patients receive the conversation tool.

Other: Informational Intervention; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

Patients receive usual care.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual/standard of care

Also known as: standard of care, standard therapy

Arm II (usual care)

Informational Intervention OTHER

Receive conversation tool

Arm I (conversation tool)

Questionnaire Administration OTHER

Ancillary studies - Baseline and follow-up questionnaires

Arm I (conversation tool); Arm II (usual care)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator
• ATS Foundation: collaborator
• Hildegard Lamfrom Endowment: collaborator
• Medical Research Foundation, Oregon: collaborator

Study Sites (2)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Donald Sullivan

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 30, 2021
• Study Start: August 7, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

US (2)