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Trial Title:
Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers
NCT ID:
NCT05940272
Condition:
Lymphoma, B-Cell
Lymphoma
Large-cell Lymphoma
Large B-cell Lymphoma
DLBCL - Diffuse Large B Cell Lymphoma
Mediastinal B-Cell Diffuse Large Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
oncologist
hemotologic oncologist
lymphoma
large cell lymphoma
large b-cell lymphoma
DLBCL
Diffuse Large B Cell Lymphoma
Mediastinal B-Cell Diffuse Large Cell Lymphoma
Hematolo-GIST
23-164
Memorial Sloan Kettering Cancer Center
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Hematolo-GIST Training
Description:
Hematologist will participate in a group Hematolo-GIST training provided remotely via the
study team.
Arm group label:
Hematologists
Intervention type:
Behavioral
Intervention name:
Participants Appointment
Description:
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.
Arm group label:
Participants Patients
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.
Criteria for eligibility:
Criteria:
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 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 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:
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
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All protocol activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly McConnell, PhD
Phone:
646-888-0026
Facility:
Name:
NEW YORK PRESBYTERIAN HOSPITAL (Data Collection Only)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Alan Astrow, MD
Phone:
646-962-2330
Facility:
Name:
Weill Cornell Medical College (Data analysis only)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Holly Prigerson, PhD
Phone:
646-962-9655
Start date:
July 3, 2023
Completion date:
July 3, 2028
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05940272
http://www.mskcc.org
