Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers
Evaluation of a Communication Intervention (Hematolo-GIST) for Large B-Cell Lymphoma Providers
1 other identifier
interventional
48
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
July 3, 2023
CompletedStudy Start
First participant enrolled
July 3, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 3, 2028
October 9, 2025
October 1, 2025
5 years
July 3, 2023
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Hematologists
EXPERIMENTALHematologists will be recruited from the lymphoma clinics at MSK
Participants Patients
EXPERIMENTALParticipant patients are being treated by a hematologic oncologist participating in this study
Interventions
Hematologist will participate in a group Hematolo-GIST training provided remotely via the study team.
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.
Eligibility Criteria
You may qualify if:
- Providers
- Currently a an MSK provider caring for patients with DLBCL (including DLBCL-transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) which are histologically similar and treated as large-cell lymphoma)
- Patients
- Per medical record, is currently being treated by a provider who is participating in this study (for the purposes of this study, "treating provider" will be defined as any provider who provides care related to the patient's lymphoma diagnosis)
- Per medical record, has a diagnosis of DLBCL including 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, relapse/ refractory disease within 12 months of 4 cycles of first line therapy OR relapse after 2 cycles of later line therapy or or autologous stem cell transplant (ASCT)
- 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:
- 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)
- What is your preferred language for healthcare? (must respond English)
You may not qualify if:
- Providers
- Per self-report, planning to leave the cancer center in the next 12 months
- Patients
- Cognitively impaired as demonstrated by (Blessed Orientation- Memory- Concentration (BOMC) score of ≥ 11
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065, United States
NEW YORK PRESBYTERIAN HOSPITAL (Data Collection Only)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly McConnell, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2023
First Posted
July 11, 2023
Study Start
July 3, 2023
Primary Completion (Estimated)
July 3, 2028
Study Completion (Estimated)
July 3, 2028
Last Updated
October 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
• 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.