Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool

Lung Carcinoma Clinical Trial

— iDECIDE  

Official title:

Improving Decision-Making Encounters in Lung Cancer (I DECide) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407168
• Other study ID #: STUDY00023160
• Secondary ID: NCI-2021-09819ST
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.

Description:

PRIMARY OBJECTIVES: I. Conduct a randomized, controlled trial evaluating the efficacy of a conversation tool on patient-centered health and decision-making outcomes among patients making lung cancer treatment decisions. A subset of participants from control and intervention groups will also have their clinic conversations with providers recorded II. Conduct in-depth, semi-structured qualitative audio or video recorded interviews among a subset of Aim 1 participants. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients review decision aid. GROUP II: Patients receive standard of care. After completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• AIM 1: Suspected lung cancer
• AIM 1: English fluency
• AIM 1: > 6-month life expectancy
• AIM 1: Score of = 3 on the cognitive impairment screener
• AIM 2 PARTICIPANTS: Participation in Aim 1
• AIM 2 CLINICIANS: Discussing lung cancer treatment decisions with Aim 1 participants
• VA-SPECIFIC REQUIREMENT (inclusion of non-Veterans): Non-Veterans will be recruited for this study. Non-Veterans are an important component to this project since they will provide outside perspective. In this way, results of this study will be more generalizable

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Other:
• Best Practice
Receive standard of care
• Health Promotion and Education
View decision aid
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Hillsboro Medical Center	Hillsboro	Oregon
United States	Adventist Health Portland	Portland	Oregon
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	American Cancer Society, Inc., Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision Satisfaction	Will be assessed using two scales: 1) The Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict. 2) The Decisional Self-Efficacy Scale, which contains 11 items. Higher scores indicate higher self-efficacy.	Up to 6 months
Primary	Efficacy of a conversation tool on patients' knowledge of lung cancer	Will be assessed using nine questions from previously validated measures.	Up 6 months
Primary	Satisfaction with Communication/Confidence in Decision	Will be assessed using the 20-item COMRADE scale. Higher scores indicate better outcomes.	Up to 6 months
Secondary	Functional Assessment of Cancer Therapy -- Lung scale	Will be assessed by the Functional Assessment of Cancer Therapy -- Lung scale. This scale has 27 items. Higher scores indicate higher quality of life.	Up to 6 months.
Secondary	Depression/Anxiety	Will be assessed using the 4 item Patient Health Questionnaire for Anxiety and Depression scale. Scores greater than or equal to 3 on the first two questions suggest anxiety, and scores greater than or equal to 3 on the last two questions suggest depression.	Up to 6 months
Secondary	Participation in Decision-Making	Will be assessed using the 2-item Control Preferences Scale. Answers of 1 or 2 on both items are categorized as "patient controlled", answers of 3 are categorized as "shared", and answers of 4 or 5 are categorized as "physician-controlled."	Up to 6 months
Secondary	Decision Regret	Will be assessed using the 5-item Decision Regret Scale. Higher scores indicate high regret.	Up to 6 months
Secondary	Quality of Communication	Will be assessed using the ~30 item Patient Assessment of cancer Communication Experiences scale. Higher scores indicate higher perceived quality of communication.	Up to 6 months
Secondary	Number of Palliative Care Referrals	Will be assessed by conducting chart review	Up to 6 months
Secondary	Treatment Decision-Making Concordance	Will be assessed by observing the treatment received and the treatment most aligned with responses to the conversation tool. If the treatment received is the same treatment the patient preferred according to the conversation tool, the treatment decision will be considered concordant.	Up to 6 months
Secondary	Acceptability	Will be assessed using the Ottawa Acceptability scale for patients in the intervention group only.	Up to 6 months