Decision Counseling Program in Increasing Shared Decision Making and Clinical Trial Participation in Patients With Stage 0-IV Lung Cancer (Free to Breathe)

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Other: Educational Intervention

• Registration Number: NCT03820557
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

This clinical trial studies how well the Decision Counseling Program works in increasing patient-physician shared decision making and participation in clinical trials for lung cancer patients. Decision aids help provide patients with information that may help them select a course of action related to their cancer care when more than one alternative is available. It also encourages shared decision making allowing patients and their providers to make health decisions together. Determining how patients make decisions about participating in a clinical trial may help doctors facilitate patient decision making and improve participation in lung cancer clinical trials.

Detailed Description

PRIMARY OBJECTIVES:

I. Facilitate patient deliberation about participation in a lung cancer clinical trial using the Decision Counseling Program (DCP).

SECONDARY OBJECTIVES:

I. Document the extent to which patient values and preferences are incorporated into physician-patient shared decision making (SDM) about cancer clinical trials.

II. Assess changes in patient knowledge, anxiety, and decisional conflict related to clinical trial participation.

III. Characterize patient and physician experience with intervention exposure.

Study Timeline

• Study Start: 2017-08-03
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Primary Completion: 2020-02-01
• Study Completion: 2020-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients diagnosed with lung cancer (Stages 0, 1, 2, 3, 4)
• Lung cancer patients for which there is an available interventional clinical trial open at Jefferson Kimmel Cancer Center
• Patients being treated by a lung medical oncologist on the Center City Campus of Thomas Jefferson University
• Able to provide informed consent
• English-speaking

Exclusion Criteria

• Inability to communicate in English
• Unable to provide informed consent
• Not eligible for an open, actively accruing interventional trial at Jefferson

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decision Counseling	Educational Intervention	Patients undergo participation in the DCP prior to an audio-recorded oncology appointment.

Primary Outcome Measures

Name	Time	Method
Patient perception related to clinical trials participation, measured by follow up survey questions	Baseline to 30 days	Will compute descriptive statistics for all sections and determine the variables on which to compare patient responses at the two time points (baseline and endpoint) using paired t-tests.

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States