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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05940272
Collaborator
(none)
48
3
60
16
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hematolo-GIST Training
  • Behavioral: Participants Appointment

Study Design

Study Type:
Observational
Anticipated Enrollment :
48 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of a Communication Intervention (Hematolo-GIST) for Large B-Cell Lymphoma Providers
Actual Study Start Date :
Jul 3, 2023
Anticipated Primary Completion Date :
Jul 3, 2028
Anticipated Study Completion Date :
Jul 3, 2028

Arms and Interventions

Arm Intervention/Treatment
Hematologists

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

Patients

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of the Hematolo-GIST intervention among hematologists and participants [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center (All protocol activities) New York New York United States 10065
2 NEW YORK PRESBYTERIAN HOSPITAL (Data Collection Only) New York New York United States 10065
3 Weill Cornell Medical College (Data analysis only) New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Kelly McConnell, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT05940272
Other Study ID Numbers:
  • 23-164
First Posted:
Jul 11, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2023