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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

About this trial

This is an interventional health services research trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Studies a U.S. FDA-regulated Device Product

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

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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