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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-07

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (conversation tool)

Patients receive the conversation tool.

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive conversation tool

Questionnaire Administration

Intervention Type OTHER

Ancillary studies - Baseline and follow-up questionnaires

Arm II (usual care)

Patients receive usual care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual/standard of care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies - Baseline and follow-up questionnaires

Interventions

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Best Practice

Receive usual/standard of care

Intervention Type OTHER

Informational Intervention

Receive conversation tool

Intervention Type OTHER

Questionnaire Administration

Ancillary studies - Baseline and follow-up questionnaires

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No