Condition or disease | Intervention/treatment | Phase |
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Liquid Tumor Cancer Psychological Feedback | Behavioral: GIST | Not Applicable |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 133 participants |
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 |
Official Title: | Giving Information Strategically and Transparently in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation |
Estimated Study Start Date : | May 2021 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
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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.
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Behavioral: GIST
The GIST intervention will train physicians in an alternative way of communicating with their patients.
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No Intervention: Usual Care
These are physician and patient participants that will communicate in their normal, unchanged way.
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Ages Eligible for Study: | 21 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Weill Cornell Medical Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Holly G Prigerson, PhD | Weill Medical College of Cornell University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 14, 2019 | ||||||||
First Posted Date ICMJE | May 22, 2019 | ||||||||
Last Update Posted Date | January 28, 2021 | ||||||||
Estimated Study Start Date ICMJE | May 2021 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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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. |
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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
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Condition ICMJE |
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Intervention ICMJE | Behavioral: GIST
The GIST intervention will train physicians in an alternative way of communicating with their patients.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Suspended | ||||||||
Estimated Enrollment ICMJE |
133 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2021 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 99 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
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 ) |
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Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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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 |
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PRS Account | Weill Medical College of Cornell University | ||||||||
Verification Date | January 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |