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Clinical Trials/NCT05940272
NCT05940272
Recruiting
N/A

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

Memorial Sloan Kettering Cancer Center2 sites in 1 country48 target enrollmentJuly 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lymphoma, B-Cell
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
48
Locations
2
Primary Endpoint
Feasibility of the Hematolo-GIST intervention among hematologists and participants
Status
Recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 3, 2023
End Date
July 3, 2028
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)
  • 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)

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (2)

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