Decision Counseling Program in Increasing Shared Decision Making and Clinical Trial Participation in Patients With Stage 0-IV Lung Cancer (Free to Breathe)
|ClinicalTrials.gov Identifier: NCT03820557|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2019
Last Update Posted : December 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Other: Educational Intervention||Not Applicable|
I. Facilitate patient deliberation about participation in a lung cancer clinical trial using the Decision Counseling Program (DCP).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|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 :||August 3, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Decision Counseling
Patients undergo participation in the DCP prior to an audio-recorded oncology appointment.
Other: Educational Intervention
Undergo Decision Counseling Program
- Patient perception related to clinical trials participation, measured by follow up survey questions [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820557
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Amy Leader, DrPH||Sidney Kimmel Cancer Center at Thomas Jefferson University|