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

NCT ID: NCT03820557

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2020-03-28

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Decision Counseling

Patients undergo participation in the DCP prior to an audio-recorded oncology appointment.

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: OTHER

Undergo Decision Counseling Program

Interventions

Educational Intervention

Undergo Decision Counseling Program

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Leader, DrPH

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 10803

Identifier Type: OTHER

Identifier Source: secondary_id

17G.352

Identifier Type: -

Identifier Source: org_study_id