GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation

NCT ID: NCT03959046

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-06-30

Brief Summary

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.

Detailed 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.

Conditions

Liquid Tumor; Cancer; Psychological Feedback

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

GIST

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.

Group Type: EXPERIMENTAL

GIST

Intervention Type: BEHAVIORAL

The GIST intervention will train physicians in an alternative way of communicating with their patients.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

GIST

The GIST intervention will train physicians in an alternative way of communicating with their patients.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly G Prigerson, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

5R35CA197730

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1807019470

Identifier Type: -

Identifier Source: org_study_id