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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02732834
Other study ID # 16-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date January 2025

Study information

Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to better understand communication between patients with lung cancer and their clinicians. The investigators are also interested in patient's perceptions of the quality of communication with his/her clinician and how these perceptions may impact patient outcomes. The clinician participating in this study and has given us permission to approach his/her eligible patients for study participation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 294
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with confirmed lung cancer diagnosis or mass suspicious of lung cancer as per clinician report and/or EMR - Lung cancer diagnosis or suspicious mass as per clinician report/EMR within 0-6 months of consent or within no more than three visits to participating clinician - Participating clinician approves his/her patient's participation in this study per clinician report. - Former (at least 100 cigarettes in lifetime and quit more than 30 days prior to enrollment) or current smoker (lifetime smoker who reports cigarette smoking within the past 30 days) as per self report or EMR; - English fluency (determined through EMR or clinician report), as we do not have the resources to translate the consultations from other languages or the surveys to other languages; - Patients must be 18 years old or older Clinician Inclusion Criteria: - An MSK attending physician (radiologists, medical oncologists, and surgeons), Nurse Practitioner (NP), Physician Assistant (PA), Fellow, Resident or Clinical Nurse Specialist (CNS) or Clinical Nurse (RN) who is a member of the Thoracic Disease Management Team or Pulmonary Service currently treating thoracic patients at MSK as per self report - Clinical has individual clinic consultations to discuss adult health assessment and/or smoking history with the target patient population: English-speaking, at least 18 years of age, has a suspicious lung mass or confirmed diagnosis, is a former/current smoker, has had no more than 3 visits with clinician or had diagnosis in past 6 months as per self-report. Exclusion Criteria: Clinician Exclusion Criteria - N/A

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaire
patients will fill out a questionnaire about their perceived stigma, satisfaction with communication, and psychological distress.
Patient Interview
Then they will participate in a brief in-person interview about their perceived stigma during the clinical consultation
Audio recordings of clinical consultations

Questionnaire
Patients will fill out a questionnaire about their perceived stigma and satisfaction with their clinician's communication.
2-hour empathic communication skills training
2-hour empathic communication skills training
Standardized Patient Assessments
pre-training SPA, post-training SPA
Training evaluation
Clinicians will complete an evaluation assessing the empathic communication training module.
Patient recruitment
6 of the clinician's patients (3 pre-training, 3 post-training) will be recruited to complete brief surveys assessing clinician communication

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (Consent and follow-up only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent and follow-up only) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent and follow-up only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent and follow-up only) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent and Follow-Up only) Uniondale New York

Sponsors (5)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Hamad Medical Corporation, University of Arizona, University of Florida, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Systematic coding of clinical encounters and the perceived stigma within the clinical consultation interview along with patient-reported data from the post-consultation questionnaire will be used. 1 year
Primary Part 1: All variables (stigma, satisfaction with communication, psychological distress) will be measured via post-consultation questionnaires 1 year
Primary Part 2: We will pilot test the effectiveness of the empathic communication skills training module for clinicians: physicians, nurse practitioners, physician assistants, fellows, residents, clinical nurses, and clinical nurse specialists by using the communication skills training module 1 year
Secondary # of patients referred to MSK's Tobacco Treatment Program (TTP) will be determined via review of the medical record and/or Tobacco Treatment Program database 1 year
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