Clinical trial NCT05940272: Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers
Official title: Evaluation of a Communication Intervention (Hematolo-GIST) for Large B-Cell Lymphoma Providers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoma, B-Cell
Lymphoma
Large-cell Lymphoma
Large B-cell Lymphoma
DLBCL - Diffuse Large B Cell Lymphoma
Mediastinal B-Cell Diffuse Large Cell Lymphoma
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Feasibility of the Hematolo-GIST intervention among hematologists and participants
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activities)
state: New York
city: New York
country: United States
facility: NEW YORK PRESBYTERIAN HOSPITAL (Data Collection Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kelly McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
References: