Liquid TumorNCT03959046
GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation
A study testing GIST in people with Liquid Tumor and Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Liquid Tumor, Cancer, Psychological Feedback
- What is being tested?
- GIST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2021to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitively impaired
- Not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical Center
New York, New York, 10021
About this study
Official title: Giving Information Strategically and Transparently in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation
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.
Read the 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.
- Conditions
- Liquid Tumor, Cancer, Psychological Feedback
- Being tested
- GIST
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GISTBehavioural
The GIST intervention will train physicians in an alternative way of communicating with their patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: GIST |
| Usual Care | No intervention | These are physician and patient participants that will communicate in their normal, unchanged way. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
Secondary outcomes (2)
Patient's emotional acceptance of their illness
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).
Measured: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
Patient's emotional acceptance of their lives
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).
Measured: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study startJun 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: The study has been withdrawn due to delays caused by COVID-19 and practical barriers to conducting the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liquid TumorStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Holly G Prigerson, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959046
- Sponsor's protocol ID
- 1807019470
- Other IDs
- 5R35CA197730
- Status last verified
- Jun 2021
- First submitted
- 14 May 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giving Information Strategically and Transparently in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT03959046
- Acronym / sponsor ID
- 1807019470
- Conditions
- Liquid Tumor, Cancer, Psychological Feedback
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been withdrawn due to delays caused by COVID-19 and practical barriers to conducting the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIST | Experimental | Behavioral: GISTGIST 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. |
| Usual Care | No intervention | –These are physician and patient participants that will communicate in their normal, unchanged way. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitively impaired
- Not fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GISTThe GIST intervention will train physicians in an alternative way of communicating with their patients. | Behavioural | GIST |
Primary outcome
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.
2 secondary outcomes
Patient's emotional acceptance of their illness
Time frame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
Patient's emotional acceptance of their lives
Time frame: 1 week, 1 month and 3 months from baseline (T2, T3, and T4)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly G Prigerson, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIST in people with Liquid Tumor and Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.