GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation

NCT03959046 | Withdrawn

• 2 other identifiers: 18070194705R35CA197730
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Liquid Tumor; Cancer; Psychological Feedback

Outcome Measures

Primary Outcomes (1)

• Change from 1 week post baseline understanding at 3 months

  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.

  1 week, 1 month and 3 months from baseline (T2, T3, and T4)

Secondary Outcomes (2)

• Patient's emotional acceptance of their illness

  1 week, 1 month and 3 months from baseline (T2, T3, and T4)

• Patient's emotional acceptance of their lives

  1 week, 1 month and 3 months from baseline (T2, T3, and T4)

Other Outcomes (4)

• The Human Connection (THC) Scale

  One week, one month and three months from baseline (T2, T3, and T4)

• Levels of anxiety and depression in patients

  1 week, 1 month and 3 months from baseline (T2, T3, and T4)

• Health Literacy in older adults compared to younger adults

  Baseline, 1 week, 1 month and 3 months from baseline (T1, T2, T3, and T4)

Study Arms (2)

GIST

EXPERIMENTAL

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.

Behavioral: GIST

Usual Care

NO INTERVENTION

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

Interventions

GIST BEHAVIORAL

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

GIST

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitively impaired
• Not fluent in English

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Holly G Prigerson, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient participants will be seeing the same physician they usually see, and they won't know if their physician was assigned to GIST or not.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 22, 2019
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 15, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after the final analysis is completed. No end date.
• Access Criteria: Upon request, we will provide the dataset to qualified investigators under a Data Use Agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)