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

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04946279
• Collaborator: Oregon Health and Science University (Other)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 58.7
• Patients Per Site: 50
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Non-Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage IA1 Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	Other: Best Practice; Other: Informational Intervention; Other: Questionnaire Administration	N/A

Detailed Description

PRIMARY OBJECTIVES:

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

2. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Decision-Making Encounters in Lung Cancer (I DECide): A Low-Literacy Conversation Tool
• Actual Study Start Date: Aug 7, 2020
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (conversation tool) Patients receive the conversation tool.	Other: Informational Intervention; Receive conversation tool; Other: Questionnaire Administration; Ancillary studies - Baseline and follow-up questionnaires
Active Comparator: Arm II (usual care) Patients receive usual care.	Other: Best Practice; Receive usual/standard of care; Other Names: standard of care standard therapy ; Other: Questionnaire Administration; Ancillary studies - Baseline and follow-up questionnaires

Outcome Measures

Primary Outcome Measures

1. Feasibility of the conversation tool [At enrollment]

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

2. Acceptability of the conversation tool [At enrollment]

   Use the Ottawa Acceptability Tool to determine acceptability of the conversation tool.

Secondary Outcome Measures

1. Anxiety [From enrollment to the end of follow-up at 8 weeks]

   Assessed using the Hospital Anxiety and Depression Scale.

2. Decisional conflict [At the end of follow-up at 8 weeks]

   Assessed using the Decisional Conflict Scale.

3. Decisional Regret [At the end of follow-up at 8 weeks]

   Assessed using the Decisional Regret Scale.

4. Perceived involvement in care [At the end of follow-up at 8 weeks]

   Assessed using the Perceived Involvement in Care Scale.

5. Shared decision-making quality [At the end of follow-up at 8 weeks]

   Assessed using the Shared Decision Making Questionnaire.

6. Decision making involvement [From enrollment to the end of follow-up at 8 weeks]

   Assessed using the Control Preferences Scale.

7. Self-efficacy [From enrollment to the end of follow-up at 8 weeks]

   Assessed using the Decision Self-Efficacy Scale.

8. Values-treatment concordance [From enrollment to the end of follow-up at 8 weeks]

   Assessed using electronic medical record (EMR).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239
2	Portland VA Medical Center	Portland	Oregon	United States	97239

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• Oregon Health and Science University

Investigators

• Principal Investigator: Donald Sullivan, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Donald R Sullivan, MD, MA, MCR, Principal Investigator, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT04946279
• Other Study ID Numbers: STUDY00020688; NCI-2021-05887; STUDY00020688
• First Posted: Jun 30, 2021
• Last Update Posted: Jun 9, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jun 9, 2022