Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers

July 3, 2023 updated by: Memorial Sloan Kettering Cancer Center

Evaluation of a Communication Intervention (Hematolo-GIST) for Large B-Cell Lymphoma Providers

The purpose of this study is to develop and test a new communication training intervention called Hematolo-GIST to help oncologists communicate with patients about their lymphoma diagnosis and advance care planning.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Revecca Saracino, PhD
  • Phone Number: 646-888-0263
  • Email: jamesr@mskcc.org

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Kelly McConnell, PhD
          • Phone Number: 646-888-0026
      • New York, New York, United States, 10065
        • Not yet recruiting
        • NEW YORK PRESBYTERIAN HOSPITAL (Data Collection Only)
        • Contact:
          • Andy Huang, MD
          • Phone Number: 646-888-0026
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Weill Cornell Medical College (Data analysis only)
        • Contact:
          • Holly Prigerson, PhD
          • Phone Number: 646-962-9655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hematologists and participants with advanced lymphomas will be recruited from MSK and NYP/BMH.

Description

Inclusion Criteria:

Hematologists

  • Currently a hemotologic oncologist providing care to patients with DLBCL

Patients

  • Per medical record, is being treated by a hematologic oncologist participating in this study
  • Per medical record, has a diagnosis of DLBCL-transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) which are histologically similar and clinically treated as large-cell lymphoma
  • Per medical record, receipt of ≥ 4 cycles of first-line therapy or 2 cycles of later-line therapy as best response to chemotherapy or relapse ≤ 12 months after autologous stem cell transplant (ACST)
  • Per medical record, received an anti-CD20 monoclonal antibody or an anthracycline as one of their qualifying regiments
  • Self-identify as Black and/or White
  • Per medical record, 18 years of age or older

  • Per self-report, fluent in English** ** Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study:

    1. How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
    2. What is your preferred language for healthcare? (must respond English)

Exclusion Criteria:

Hematologists

  • Per self-report, planning to leave the cancer center in the next 12 months

Patients

  • Moderately or severely cognitively impaired as demonstrated by Short Portable Mental Status Questionnaire score > 4
  • Per research staff judgment and/or self-report, too ill or weak to complete study procedures
  • Per medical record or self-report, receiving hospice care at the time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Behavioral: Participants Appointment
Participants will meet with Hematolo-GIST trained hematologists. Participants will consent to having their appointment audio-recorded on password-protected devices or MSK approved secure platforms.
Hematologists
Behavioral: Hematolo-GIST Training
Hematologist will participate in a group Hematolo-GIST training provided remotely via the study team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the Hematolo-GIST intervention among hematologists and participants
Time Frame: Up to 1 year
Feasbility is defined as ≥70% of screened eligible hematologists and participants enrolling in the study and ≥80% of hematologists learning the approach
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Kelly McConnell, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Estimated)

July 3, 2028

Study Completion (Estimated)

July 3, 2028

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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