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CompletedNCT03820557Updated Apr 29, 2025

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

An interventional study of Educational Intervention in Lung Cancer, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Aug 2017, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Lung Cancer

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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 44 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 125 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Decision Counseling

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

    Other: Educational Intervention

Interventions

  • OtherEducational Intervention

    Undergo Decision Counseling Program

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 30 days

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Study locations

1 site
  • Sidney Kimmel Cancer Center at Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03820557
Lead sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Responsible party
Sponsor
First posted
Jan 29, 2019
Start date
Aug 3, 2017
Primary completion
Feb 1, 2020
Completion
Mar 28, 2020
Last update
Apr 29, 2025

Study contacts

Amy Leader, DrPH
principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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