NCT02732834

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2016Jan 2027

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

11 years

First QC Date

March 14, 2016

Last Update Submit

February 3, 2026

Conditions

Keywords

Clinician-Patient Communication16-001

Outcome Measures

Primary Outcomes (3)

  • 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

  • Part 1: All variables (stigma, satisfaction with communication, psychological distress)

    will be measured via post-consultation questionnaires

    1 year

  • 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 Outcomes (1)

  • # of patients referred to MSK's Tobacco Treatment Program (TTP)

    1 year

Study Arms (4)

Part 1: Lung patients

Following informed consent, the patient will complete the patient questionnaire, either electronically, by phone, or on paper. Patients who prefer to complete the survey electronically will be emailed a link to access to a secure electronic (web-based) version of the study assessment which they will have access to from any computer. We will include an introductory email with the survey link. Will audio-record actual patient-physician clinical consultations with lung cancer patients at Memorial Sloan Kettering (MSK). Completing the survey will take about 15 minutes. Answer a few open-ended questions about the consultation with the doctor. We will audio record your answers to these questions. This will take about 15 minutes.

Behavioral: QuestionnaireBehavioral: Patient InterviewBehavioral: Audio recordings of clinical consultations

Part 1: Thoracic physicians and clinicians

Will have 5 visits/consultations with their patients audio recorded.

Behavioral: Audio recordings of clinical consultations

Part 2: Lung patients

Following informed consent, the patient will complete the patient questionnaire, either electronically, by phone, or on paper. Patients who prefer to complete the survey electronically will be emailed a link to access to a secure electronic (web-based) version of the study assessment which they will have access to from any computer. Completing the survey will take about 15 minutes.

Behavioral: Questionnaire

Part 2: Thoracic and pulmonary clinicians

Following informed consent, clinicians will be scheduled to participate in a 2 hour training on empathic communication with lung cancer patients. Surveys will be collected from 6 patients (3 pre-training, 3 post-training). Clinicians will complete one standardized patient assessment before training (pre-SPA) and one assessment after training (post-SPA). These are 12-minute video-recorded clinic consultations with standardized patients (trained actors).

Behavioral: 2-hour empathic communication skills trainingBehavioral: Standardized Patient AssessmentsBehavioral: Training evaluationBehavioral: Patient recruitment

Interventions

Part 1: Lung patientsPart 1: Thoracic physicians and clinicians
QuestionnaireBEHAVIORAL

patients will fill out a questionnaire about their perceived stigma, satisfaction with communication, and psychological distress.

Part 1: Lung patients

2-hour empathic communication skills training

Part 2: Thoracic and pulmonary clinicians

pre-training SPA, post-training SPA

Part 2: Thoracic and pulmonary clinicians

Clinicians will complete an evaluation assessing the empathic communication training module.

Part 2: Thoracic and pulmonary clinicians

6 of the clinician's patients (3 pre-training, 3 post-training) will be recruited to complete brief surveys assessing clinician communication

Part 2: Thoracic and pulmonary clinicians

Then they will participate in a brief in-person interview about their perceived stigma during the clinical consultation

Part 1: Lung patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSK thoracic clinic, pulmonary clinic

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth (Consent and follow-up only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and follow-up only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent and follow-up only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent and follow-up only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent and Follow-Up only)

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surveys and QuestionnairesPatient Selection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthResearch DesignMethodsPatient Care ManagementHealth Services Administration

Study Officials

  • Jamie Ostroff, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

April 11, 2016

Study Start

January 1, 2016

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations