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

Lung Cancer Clinical Trial

Official title:

Increasing Shared Decision Making and Patient Participation in Lung Cancer Clinical Trials (Free to Breathe)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820557
• Other study ID #: 17G.352
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: March 28, 2020

Study information

• Verified date: September 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 28, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Educational Intervention
Undergo Decision Counseling Program

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient perception related to clinical trials participation, measured by follow up survey questions	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.	Baseline to 30 days

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University
•   Thomas Jefferson University Hospital