GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation

Overview

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 Title of Study: “Giving Information Strategically and Transparently in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: Usual Care
    • These are physician and patient participants that will communicate in their normal, unchanged way.

Clinical Trial Outcome Measures

Primary Measures

  • Change from 1 week post baseline understanding at 3 months
    • Time Frame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
    • Evidence that patients assigned to physicians trained in the GIST approach will have improved recall of information and be able to answer more questions correctly about HSCT/BMT than those assigned to care as usual. The researchers have developed a brief assessment of patient knowledge of: a) why the participants are a candidate for HSCT/BMT; b) what the procedure involves; c) risks and benefits posed by HSCT/BMT. The assessment will consist of multiple choice questions, with one fill-in-the-diagram question. The high score is 90, and the low score is 18. A score of 90 means that the participant fully understands the three points listed above. A score of 18 means that the participant has little to no understanding of the three points listed above.

Secondary Measures

  • Patient’s emotional acceptance of their illness
    • Time Frame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
    • We will use 5 relevant items from the validated PEACE scale which asks patients about how accepting they are of their illness. Responses include “not at all”, “to a slight extent”, “to some extent”, “to a large extent”. The questionnaire is composed of two combined subscales: a 2-item “Peaceful Acceptance” and a 3-item “Struggle with Illness” subscale. Both subscales are associated with patients’ self-reported peacefulness “Struggle with Illness” scores are associated with acknowledgement of cognitive terminal illness. The low score for this scale is 5 (indicating little acceptance) and the high score is 20 (indicating high acceptance).
  • Patient’s emotional acceptance of their lives
    • Time Frame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
    • The MEPSI is an 8 item questionnaire (shortened from the original) that asks patients to respond to phrases regarding how they view their lives. Responses include “not at all”, “to a slight extent”, “to some extent”, “to a large extent”. The questionnaire is composed of two combined subscales: a 4 item “Positive” subscale and a 4-item “Negative” subscale. The low score for this scale is 8 (indicating little acceptance) and the high score is 32 (indicating high acceptance).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Weill Medical College of Cornell University
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Holly G Prigerson, PhD, Principal Investigator, Weill Medical College of Cornell University

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