## Protocol Section
### Identification Module
**NCT ID:** NCT04946279

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

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

#### Organization Study ID Info
**ID:** STUDY00020688
#### Organization
**Class:** OTHER
**Full Name:** OHSU Knight Cancer Institute
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2021-05887
**Type:** REGISTRY
**Domain:** OHSU Knight Cancer Institute
**ID:** STUDY00020688
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-14

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-08-07

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2021-06-30
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-23
**Study First Submit QC Date:** 2021-06-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Oregon Health and Science University

**Class:** UNKNOWN

**Name:** ATS Foundation

**Class:** UNKNOWN

**Name:** Hildegard Lamfrom Endowment

**Class:** OTHER

**Name:** Medical Research Foundation, Oregon

#### Lead Sponsor

**Class:** OTHER

**Name:** OHSU Knight Cancer Institute

#### Responsible Party

**Investigator Affiliation:** OHSU Knight Cancer Institute

**Investigator Full Name:** Donald R Sullivan, MD, MA, MCR

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed Description:** 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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 98

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive the conversation tool.

**Intervention Names:**

- Other: Informational Intervention

- Other: Questionnaire Administration

**Label:** Arm I (conversation tool)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients receive usual care.

**Intervention Names:**

- Other: Best Practice

- Other: Questionnaire Administration

**Label:** Arm II (usual care)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm II (usual care)

**Description:** Receive usual/standard of care

**Name:** Best Practice

**Other Names:**

- standard of care

- standard therapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Arm I (conversation tool)

**Description:** Receive conversation tool

**Name:** Informational Intervention

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Arm I (conversation tool)

- Arm II (usual care)

**Description:** Ancillary studies - Baseline and follow-up questionnaires

**Name:** Questionnaire Administration

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The number of patients enrolled divided by the number of patients offered enrollment.

**Measure:** Feasibility of the conversation tool

**Time Frame:** At enrollment

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

**Measure:** Acceptability of the conversation tool

**Time Frame:** At enrollment

#### Secondary Outcomes

**Description:** Assessed using the Hospital Anxiety and Depression Scale.

**Measure:** Anxiety

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

**Description:** Assessed using the Decisional Conflict Scale.

**Measure:** Decisional conflict

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

**Description:** Assessed using the Decisional Regret Scale.

**Measure:** Decisional Regret

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

**Description:** Assessed using the Perceived Involvement in Care Scale.

**Measure:** Perceived involvement in care

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

**Description:** Assessed using the Shared Decision Making Questionnaire.

**Measure:** Shared decision-making quality

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

**Description:** Assessed using the Control Preferences Scale.

**Measure:** Decision making involvement

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

**Description:** Assessed using the Decision Self-Efficacy Scale.

**Measure:** Self-efficacy

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

**Description:** Assessed using electronic medical record (EMR).

**Measure:** Values-treatment concordance

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

### Eligibility Module

**Eligibility Criteria:** 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

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Portland

**Country:** United States

**Facility:** OHSU Knight Cancer Institute

**State:** Oregon

**Zip:** 97239

**Location 2:**

**City:** Portland

**Country:** United States

**Facility:** Portland VA Medical Center

**State:** Oregon

**Zip:** 97239

#### Overall Officials

**Official 1:**

**Affiliation:** OHSU Knight Cancer Institute

**Name:** Donald Sullivan

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Lung Non-Small Cell Carcinoma

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Misc Info Module

- Version Holder: 2024-05-24
