Decision Counseling Program in Increasing Shared Decision Making and Clinical Trial Participation in Patients With Stage 0-IV Lung Cancer (Free to Breathe)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Lung Cancer
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
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Decision Counseling
Arm Description
Patients undergo participation in the DCP prior to an audio-recorded oncology appointment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03820557
First Posted
January 25, 2019
Last Updated
September 7, 2022
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT03820557
Brief Title
Decision Counseling Program in Increasing Shared Decision Making and Clinical Trial Participation in Patients With Stage 0-IV Lung Cancer (Free to Breathe)
Official Title
Increasing Shared Decision Making and Patient Participation in Lung Cancer Clinical Trials (Free to Breathe)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
March 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision Counseling
Arm Type
Experimental
Arm Description
Patients undergo participation in the DCP prior to an audio-recorded oncology appointment.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Intervention Description
Undergo Decision Counseling Program
Primary Outcome Measure Information:
Title
Patient perception related to clinical trials participation, measured by follow up survey questions
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Leader, DrPH
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Decision Counseling Program in Increasing Shared Decision Making and Clinical Trial Participation in Patients With Stage 0-IV Lung Cancer (Free to Breathe)
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