Lymphoma, B-CellNCT05940272
Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers
A study testing Hematolo-GIST Training and Participants Appointment in people with Lymphoma, B-Cell and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell, Lymphoma, Large-cell Lymphoma
- What is being tested?
- Hematolo-GIST Training and Participants Appointment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jul 2023to 3 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065
Kelly McConnell, PhD, 646-888-0026
- Not yet recruiting
NEW YORK PRESBYTERIAN HOSPITAL (Data Collection Only)
New York, New York, 10065
Alan Astrow, MD, 646-962-2330
About this study
Official title: Evaluation of a Communication Intervention (Hematolo-GIST) for Large B-Cell Lymphoma Providers
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.
- 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
- Being tested
- Hematolo-GIST Training, Participants Appointment
- 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
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematolo-GIST TrainingBehavioural
Hematologist will participate in a group Hematolo-GIST training provided remotely via the study team.
Participants AppointmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hematologists | Experimental | Hematologists will be recruited from the lymphoma clinics at MSK Receives: Behavioral: Hematolo-GIST Training |
| Participants Patients | Experimental | Participant patients are being treated by a hematologic oncologist participating in this study Receives: Behavioral: Participants Appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start3 Jul 2023
- Primary completion3 Jul 2028 (estimated)
- Study completion3 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly McConnell, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940272
- Sponsor's protocol ID
- 23-164
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: • 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Communication Intervention (Hematolo-GIST) for Large B-Cell Lymphoma Providers
- ClinicalTrials.gov ID
- NCT05940272
- Acronym / sponsor ID
- 23-164
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 3 Jul 2028 (estimated)
- Study completion
- 3 Jul 2028 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematologists | Experimental | Behavioral: Hematolo-GIST TrainingHematologists will be recruited from the lymphoma clinics at MSK |
| Participants Patients | Experimental | Behavioral: Participants AppointmentParticipant patients are being treated by a hematologic oncologist participating in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematolo-GIST TrainingHematologist will participate in a group Hematolo-GIST training provided remotely via the study team. | Behavioural | Hematologists |
| Participants AppointmentParticipants 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. | Behavioural | Participants Patients |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly McConnell, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hematolo-GIST Training and Participants Appointment in people with Lymphoma, B-Cell and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly McConnell, PhD (646-888-0026, McConneK@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Hematolo-GIST intervention among hematologists and participants (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.