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

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03820557

Collaborator

(none)

Enrollment

Location

Arm

46.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: Educational Intervention	N/A

Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

Document the extent to which patient values and preferences are incorporated into physician-patient shared decision making (SDM) about cancer clinical trials.
Assess changes in patient knowledge, anxiety, and decisional conflict related to clinical trial participation.
Characterize patient and physician experience with intervention exposure.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Aug 3, 2017

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decision Counseling Patients undergo participation in the DCP prior to an audio-recorded oncology appointment.	Other: Educational Intervention Undergo Decision Counseling Program

Arm

Intervention/Treatment

Experimental: Decision Counseling

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

Other: Educational Intervention

Undergo Decision Counseling Program

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

Principal Investigator: Amy Leader, DrPH, Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Sidney Kimmel Cancer Center at Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT03820557

Other Study ID Numbers:

17G.352

First Posted:

Jan 29, 2019

Last Update Posted:

Jun 4, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Jun 4, 2021