GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation

Weill Cornell Medicine (WCM)

Status: Withdrawn

Conditions: Psychological Feedback; Cancer; Liquid Tumor

Treatments: Behavioral: GIST

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03959046

5R35CA197730 (U.S. NIH Grant/Contract)

1807019470

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of using GIST language when speaking to patients about bone marrow and hematopoietic stem cell transplantation.

Full description

Hematopoietic stem cell/bone marrow transplantation (HSCT/BMT) is a high-risk, complicated procedure that is poorly understood by patients, posing a challenge for informed decision-making. One study found that 69.7% of patients needed more information about HSCT to make an informed decision. Furthermore, for most patients who seek HSCT/BMT as treatment, transplantation is the only viable option for long-term, disease-free survival. In light of limited options, it is often assumed that patients will choose to undergo transplantation by default, which might undermine efforts to ensure that patients are fully informed. Given the context in which the decision to undergo transplantation are made, there is a clear and present need to ensure that patients are properly informed about HSCT/BMT.

Unfortunately, this need does not seem to be adequately met. For example, studies have shown that patients tend not to remember rates of risks and complications. One study found that after completing HSCT, patients recalled a mortality risk rate lower than those provided by physicians at their initial consultation (20% vs. 30%, respectively). Findings such as this highlight the need to improve the informed consent process for patients confronting the decision to undergo HSCT/BMT.

The present study aims to improve the informed consent process by proposing a new approach to patient-physician communication, called Giving Information Simply and Transparently (GIST), that will train physicians to speak more understandably, with the goal of improving patients understanding of the procedures they intend to pursue. This approach is based upon Dr. Valerie Reyna's Fuzzy Trace Theory which posits that patients focus on the bottom-line gist of information when formulating their treatment preferences. Patient understanding will be tested via assessments administered after their consultation visit, 30 days after initiation of chemotherapy, and 100 days after initiation of chemotherapy.

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute myeloid leukemia with high or intermediate risk in first complete remission acute myeloid leukemia OR myelodysplastic syndrome beyond first remission chronic myeloid leukemia with accelerated phase or blast crisis acute lymphocytic leukemia Myeloma lymphoma with a sensitive relapse lymphoma with a resistant relapse first time undergoing consultation at this institution's HSCT/BMT program Fluent in English

Exclusion criteria

• Cognitively impaired
• Not fluent in English

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

GIST

Experimental group

Description:

GIST is an alternative way of speaking to patients. In order for patients to get the "gist," Hematologists will ensure that patients walk away from their initial consultation understanding: why they are candidates for bone marrow transplant (BMT), what the process for BMT is, and the major risks involved.

Treatment:

Behavioral: GIST

Usual Care

No Intervention group

Description:

These are physician and patient participants that will communicate in their normal, unchanged way.