Clinical trial NCT03959046: GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation
Official title: Giving Information Strategically and Transparently in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Liquid Tumor
Cancer
Psychological Feedback
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2019-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from 1 week post baseline understanding at 3 months
timeFrame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
Secondary outcomes:
measure: Patient's emotional acceptance of their illness
timeFrame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
measure: Patient's emotional acceptance of their lives
timeFrame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
Other outcomes:
measure: The Human Connection (THC) Scale
timeFrame: One week, one month and three months from baseline (T2, T3, and T4)
measure: Levels of anxiety and depression in patients
timeFrame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
measure: Health Literacy in older adults compared to younger adults
timeFrame: Baseline, 1 week, 1 month and 3 months from baseline (T1, T2, T3, and T4)
measure: Assessment of patient's health literacy
timeFrame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Holly G Prigerson, PhD
role: PRINCIPAL_INVESTIGATOR
References: