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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940272
• Other study ID #: 23-164
• Status: Recruiting
• Start date: July 3, 2023
• Est. completion date: July 3, 2028

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kelly McConnell, PhD
• Phone: 646-888-0026
• Email: McConneK[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 3, 2028
• Est. primary completion date: July 3, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Large B-cell Lymphoma
• Large-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Intervention

Behavioral:
• Hematolo-GIST Training
Hematologist will participate in a group Hematolo-GIST training provided remotely via the study team.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All protocol activities)	New York	New York
United States	NEW YORK PRESBYTERIAN HOSPITAL (Data Collection Only)	New York	New York
United States	Weill Cornell Medical College (Data analysis only)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Hematolo-GIST intervention among hematologists and participants	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

External Links

•   Memorial Sloan Kettering Cancer Center