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GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03959046
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date January 3, 2020
Actual Study Start Date  ICMJE November 30, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 20, 2019)
  • The Human Connection (THC) Scale [ Time Frame: One week, one month and three months from baseline (T2, T3, and T4) ]
    The effect on changing physician communication on patient-physician relationships will be measured by The Human Connection (THC) scale. THC is a validated 16 item questionnaire that measures the extent to which patients felt a sense of mutual understanding, caring, and trust with their physicians. Patients are asked to circle one of four phrases that answers the questions. The 16-item THC questionnaire was internally consistent (Cronbach's α =.90) and valid, based on its expected positive association with emotional acceptance of the terminal illness (r=.31, P<.0001). Scores range from 16 (the lowest score, indicating a weak therapeutic alliance) and 64 (the high score, indicating a strong therapeutic alliance).
  • Levels of anxiety and depression in patients [ Time Frame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4) ]
    levels of anxiety and depression will be assessed via the Hospital Anxiety and Depression Scale (HADS). It is a verified and brief 14-item tool that asks patients to choose a 1 out of 4 possible responses to each statement, with each response being assigned to a score of 0, 1, 2, or 3. 7 statements correspond to measuring depression, while the other 7 corresponding to measuring anxiety. Score of 0-7 indicates that the patient is "normal; 8-10 indicates the patient is borderline; and 11-21 indicates abnormal.
  • Health Literacy in older adults compared to younger adults [ Time Frame: Baseline, 1 week, 1 month and 3 months from baseline (T1, T2, T3, and T4) ]
    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. We will compare the scores of older adults (>65) to younger adults (<65) to see which group overall has a higher score.
  • Assessment of patient's health literacy [ Time Frame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4) ]
    Assessment of patient's health literacy via Rapid Estimate of Adult Literacy in Medicine - Short Form(REALM-SF) will be administered to control for variable health literacy. REALM-SF is a validated and brief literacy assessment tool of a patient's health literacy. REALM-SF consists of a list of 7 medically related words that is shown to the patient. Patients are asked to read the words out loud in order of the list, with the option of saying "pass" when they encounter a word that they do not recognize, allowing them to move onto the next word; alternatively, patients taking longer than 5 seconds to read a word will be told to move onto the next word by the interviewer. Each word a patient recognizes is a point that is used to score the assessment. 0 points is equivalent to a 3rd grade reading level, 1-3 points is equivalent to a 4th to 6th grade level, 4-6 points is equivalent to a 7th to 8th grade level, and 7 points is equivalent to at least a high school level.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation
Official Title  ICMJE Giving Information Strategically and Transparently in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
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.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Liquid Tumor
  • Cancer
  • Psychological Feedback
Intervention  ICMJE Behavioral: GIST
The GIST intervention will train physicians in an alternative way of communicating with their patients.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: GIST
  • No Intervention: Usual Care
    These are physician and patient participants that will communicate in their normal, unchanged way.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
133
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joseph Sklar, BA 646-962-5637 jos4006@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959046
Other Study ID Numbers  ICMJE 1807019470
5R35CA197730 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Results will be presented at scientific meetings in the form of posters and oral presentations
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.
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Holly G Prigerson, PhD Weill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP