Hematopoietic Stem Cell Transplant (HSCT)NCT03710031
Developing Self-Management Interventions After HCT
An observational study of Hematopoietic Stem Cell Transplant (HSCT), run by University of Florida at 1 site in United States.
Trial summary
This is a prospective, longitudinal, observational trial to evaluate quality of life in hematopoietic stem cell transplant survivors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplant (HSCT)
- What is being tested?
- PNS Tracking
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 31 Jul 2021
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hematopoietic Stem Cell Transplant (HSCT) Survivors. Survival rates continue to increase as treatment protocols improve; by 2030, an estimated half-million HSCT recipients in the United States will be long-term survivors. However, HSCT survivors continue to face many mental, emotional, and physical challenges that threaten QOL, which, according to the American Society of Clinical Oncology, is the most important treatment outcome next to survival. Therefore, a prospective, observational design to longitudinally examine these factors in 50 adult (at least 18 years of age) survivors of HSCT to lay the groundwork for the future development of a targeted dietary self-management intervention to mitigate PN symptoms in this growing group of HSCT survivors is being planned.
Who may be able to join
- patients scheduled for HSCT with the Bone Marrow Transplant Program at the UF Health Cancer Center (UFHCC) [specifically bone marrow diseases, myelodysplastic-myeloproliferative diseases, lymphoma, bone marrow neoplasm or leukemia]
- Written informed consent obtained from the subject to take Mini-Mental State Examination (MMSE) prior to enrollment on the study and to comply with all the study-related procedures.
- Score at least a 24 on the Mini-Mental State Examination (MMSE) prior to enrollment
Who cannot join
- Subjects with any of the following will not be eligible for study participation:
- Patient has prior history of HSCT
- Patient has diagnosis that could interfere with neurocognitive function such as dementia, a concurrent diagnosis of systemic lupus erythematous or multiple sclerosis, diagnosis of a major depressive disorder, schizophrenia or untreated bipolar disease.
- Pregnant women are not eligible for transplant therefore will not be enrolled on the study
- Inability to comply with the study and/or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Cancer Hospital
Gainesville, Florida, 32608
About this study
Official title: Developing the Bio-behavioral Foundation for Self-Management of Psycho-neurological Symptoms in Hematopoietic Cell Transplant (HCT) Survivors
This is a prospective, longitudinal, observational trial to evaluate quality of life in hematopoietic stem cell transplant survivors.
Read the detailed description
Hematopoietic stem cell transplant (HSCT) survival rates continue to increase as treatment protocols improve. However, HSCT survivors face many mental, emotional, and physical challenges that threaten quality of life (QOL), which, according to the American Society of Clinical Oncology, is the most important treatment outcome next to survival. Psychoneurologic symptoms (PNS) significantly diminish QOL after HSCT. PNS often co-occur and may be associated with inflammation related to perturbations of the gut microbiota. This project will track the interplay among these factors in 50 adult survivors of HSCT to lay the groundwork for a targeted dietary self-management intervention to mitigate PN symptoms.This is to be achieved by elucidating the complex bio-behavioral mechanisms of distressing symptoms in HCT patients such as neurocognitive dysfunction, fatigue, anxiety, depression and pain, inflammation (cytokines and C-reactive protein), gut microbiota [(GM) richness and diversity] and diet (macronutrients: carbohydrates, fats and proteins).
- Being tested
- PNS Tracking
- Keywords
- psychoneurological symptoms (PNS), quality of life (QOL), hematopoietic stem cell transplant (HSCT), microbiota gut-brain axis, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNS TrackingOther
Through blood and stool samples the study team will track the interplay among PNS as they relate to diminished QOL. Symptoms tracked include neurocognitive dysfunction, fatigue, anxiety, depression and pain, inflammation (cytokines and C-reactive protein), gut microbiota [(GM) richness and diversity] and diet (macronutrients: carbohydrates, fats and proteins).
| Study group | Role | What they receive |
|---|---|---|
| HSCT Survivors | PNS tracking will occur through blood and stool samples to track the interplay among psychoneurologic symptoms (PNS) as they relate to diminished QOL among survivors of HSCT. Receives: Other: PNS Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT
Cytokines will be analyzed using a multiplex assay by Millipore Company. Compared to the traditional enzyme-linked immunosorbant assays (ELISA), the multiplex is comparable and more sensitive to lower concentration levels of cytokines than the ELISA. One laser identifies a specific bead and another laser identifies the reported antibody associated with the bead-bound cytokine. One hundred beads for each of the 17 cytokines in every sample are assayed and a mean cytokine binding for the sample is determined. The manufacturer reports that the assay accurately measures cytokine values in a range of 1-2500pg/ml. Serum CRP will be measured using the ALPCO's (American Laboratory Products Company) high-sensitivity CRP assay which uses latex particle enhanced immunoturbidimetry for quantitative CRP determination.
Measured: Baseline; Day 30; Day 100
Change in diversity and levels of fecal microbes of individuals post allogeneic HSCT
Fecal microbial DNA will be extracted from between 50-200 mg of fecal material. The 16S ribosomal gene (V4 region) of each sample will be amplified using a barcoding system to allow multiplexing with the Illumina MiSeq system. We will use UNIFRAC algorithm to evaluate the null hypothesis that the structure of the microbial community is insensitive to cGVHD and symptoms of cGVHD. Differences in taxa are implicated by our high throughput sequencing methods will be confirmed by other techniques including culturing (where appropriate) and qPCR with taxa-specific primers.
Measured: Baseline; Day 30; Day 100
Change in behavioral responses (symptoms) of individuals post allogeneic HSCT
Measured: Baseline; Day 30; Day 100
Secondary outcomes (6)
Health Promoting Lifestyle Profile II (HPLPII)
The Health Promoting Lifestyle Profile II (HPLPII) will be used to identify lifestyle choices that may affect relationships and differences between groups. HPLPII measures health promoting behaviors across several dimensions with subscales of health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations and stress management. This is a 52-item summated behavior rating scale using a 4-point response format to measure the frequency of self-reported health-promoting behaviors. It is a well validated toll and takes approximately 10 minutes to complete.
Measured: Baseline; Day 30; Day 100
Brief Pain Inventory (BPI)
Pain will be assessed using the Brief Pain Inventory (BPI). The BPI was created to evaluate two dimensions of pain: 1) the severity and 2) the interference. This tool is well validated with Cronbach's alpha .80-.87 pain severity and .89-.92 for interference.22 The BPI consists of a body diagram to indicate location of pain and a general question asking if pain is present. Four items assess pain intensity or severity and seven item s assess pain interference. Both use an eleven point scale ranging from 0 (no pain or interference) to 10 (worst pain or interference). This instrument takes approximate five minutes to complete.
Measured: Baseline; Day 30; Day 100
Hospital Anxiety and Depression Scale (HADS)
Depressive symptoms will be assessed using the subscale for depression from the Hospital Anxiety and Depression Scale (HADS). 23This instrument is used to assess the presence and severity of anxiety and depressive symptoms over a seven day period. The depression subscale is comprised of seven items using a four point scale ranging from 0 (least severe) to 3 (most severe). Cronbach's alpha has been found to be high (.82-.90) for the HADS depression subscale.
Measured: Baseline; Day 30; Day 100
Brief Fatigue Inventory (BFI)
Fatigue will be assessed using the Brief Fatigue Inventory (BFI). The BFI is a nine item, eleven point scale that assesses physical, affective, cognitive and social domains in a two dimensions, fatigue intensity and interference. Severity scores are as follows: 1) mild (1-3), 2) moderate (4-6) and 3) severe (7-10). This tool is well establish and validated. The Cronbach's alpha ranged from .95-.96 for individual items and an internal consistency of .96 overall. The questionnaire takes approximately five minutes to complete and a global score can be ascertained by averaging the total score.
Measured: Baseline; Day 30; Day 100
Memorial Symptom Assessment Scale (MSAS-SF)
To comprehensively explore symptoms, the Memorial Symptom Assessment Scale (MSAS-SF) will be used to measure multiple dimensions (frequency, severity, and distress) of 32 common cancer symptoms. The Cronbach alpha for the MSAS-SF subscales ranged from .76-.86 and the test-retest correlation coefficients ranged from .86-.94 at one day and one week respectively. The total time to complete this form is approximately 10 minutes. This form allows for patients to identify and quantify "other" symptoms.
Measured: Baseline; Day 30; Day 100
Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT)
Health related quality of life (HRQOL) will be measured using the Functional Assessment of Cancer Therapy- Bone Marrow Transplantation (FACT-BMT). This is a well validated HRQOL measure. This is a 27-item questionnaire asking questions across four domains: physical well-being, social well-being, emotional well-being and functional well-being. This measure takes about 10 minutes to complete.
Measured: Baseline; Day 30; Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start4 Feb 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell Transplant (HSCT)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Debra L Kelly, PhD, RN, OCN, Principal investigator, College of Nursing, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710031
- Sponsor's protocol ID
- IRB201802329
- Other IDs
- R21NR017749, OCR18772
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2018
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kelly DL, Lyon DE, Yoon SL, Horgas AL. The Microbiome and Cancer: Implications for Oncology Nursing Science. Cancer Nurs. 2016 May-Jun;39(3):E56-62. doi: 10.1097/NCC.0000000000000286.
PubMed 26110573
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing the Bio-behavioral Foundation for Self-Management of Psycho-neurological Symptoms in Hematopoietic Cell Transplant (HCT) Survivors
- ClinicalTrials.gov ID
- NCT03710031
- Acronym / sponsor ID
- IRB201802329
- Keywords
- psychoneurological symptoms (PNS), quality of life (QOL), hematopoietic stem cell transplant (HSCT), microbiota gut-brain axis, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 17 Oct 2018 (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.
This is a prospective, longitudinal, observational trial to evaluate quality of life in hematopoietic stem cell transplant survivors.
Detailed description
Hematopoietic stem cell transplant (HSCT) survival rates continue to increase as treatment protocols improve. However, HSCT survivors face many mental, emotional, and physical challenges that threaten quality of life (QOL), which, according to the American Society of Clinical Oncology, is the most important treatment outcome next to survival. Psychoneurologic symptoms (PNS) significantly diminish QOL after HSCT. PNS often co-occur and may be associated with inflammation related to perturbations of the gut microbiota. This project will track the interplay among these factors in 50 adult survivors of HSCT to lay the groundwork for a targeted dietary self-management intervention to mitigate PN symptoms.This is to be achieved by elucidating the complex bio-behavioral mechanisms of distressing symptoms in HCT patients such as neurocognitive dysfunction, fatigue, anxiety, depression and pain, inflammation (cytokines and C-reactive protein), gut microbiota [(GM) richness and diversity] and diet (macronutrients: carbohydrates, fats and proteins).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSCT Survivors | – | Other: PNS TrackingPNS tracking will occur through blood and stool samples to track the interplay among psychoneurologic symptoms (PNS) as they relate to diminished QOL among survivors of HSCT. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hematopoietic Stem Cell Transplant (HSCT) Survivors. Survival rates continue to increase as treatment protocols improve; by 2030, an estimated half-million HSCT recipients in the United States will be long-term survivors. However, HSCT survivors continue to face many mental, emotional, and physical challenges that threaten QOL, which, according to the American Society of Clinical Oncology, is the most important treatment outcome next to survival. Therefore, a prospective, observational design to longitudinally examine these factors in 50 adult (at least 18 years of age) survivors of HSCT to lay the groundwork for the future development of a targeted dietary self-management intervention to mitigate PN symptoms in this growing group of HSCT survivors is being planned.
Key inclusion criteria (3 listed)
- patients scheduled for HSCT with the Bone Marrow Transplant Program at the UF Health Cancer Center (UFHCC) [specifically bone marrow diseases, myelodysplastic-myeloproliferative diseases, lymphoma, bone marrow neoplasm or leukemia]
- Written informed consent obtained from the subject to take Mini-Mental State Examination (MMSE) prior to enrollment on the study and to comply with all the study-related procedures.
- Score at least a 24 on the Mini-Mental State Examination (MMSE) prior to enrollment
Key exclusion criteria (5 listed)
- Subjects with any of the following will not be eligible for study participation:
- Patient has prior history of HSCT
- Patient has diagnosis that could interfere with neurocognitive function such as dementia, a concurrent diagnosis of systemic lupus erythematous or multiple sclerosis, diagnosis of a major depressive disorder, schizophrenia or untreated bipolar disease.
- Pregnant women are not eligible for transplant therefore will not be enrolled on the study
- Inability to comply with the study and/or follow-up procedures.
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 |
|---|---|---|
| PNS TrackingThrough blood and stool samples the study team will track the interplay among PNS as they relate to diminished QOL. Symptoms tracked include neurocognitive dysfunction, fatigue, anxiety, depression and pain, inflammation (cytokines and C-reactive protein), gut microbiota [(GM) richness and diversity] and diet (macronutrients: carbohydrates, fats and proteins). | Other | HSCT Survivors |
Primary outcome
Change in plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT
Time frame: Baseline; Day 30; Day 100
Cytokines will be analyzed using a multiplex assay by Millipore Company. Compared to the traditional enzyme-linked immunosorbant assays (ELISA), the multiplex is comparable and more sensitive to lower concentration levels of cytokines than the ELISA. One laser identifies a specific bead and another laser identifies the reported antibody associated with the bead-bound cytokine. One hundred beads for each of the 17 cytokines in every sample are assayed and a mean cytokine binding for the sample is determined. The manufacturer reports that the assay accurately measures cytokine values in a range of 1-2500pg/ml. Serum CRP will be measured using the ALPCO's (American Laboratory Products Company) high-sensitivity CRP assay which uses latex particle enhanced immunoturbidimetry for quantitative CRP determination.
Change in diversity and levels of fecal microbes of individuals post allogeneic HSCT
Time frame: Baseline; Day 30; Day 100
Fecal microbial DNA will be extracted from between 50-200 mg of fecal material. The 16S ribosomal gene (V4 region) of each sample will be amplified using a barcoding system to allow multiplexing with the Illumina MiSeq system. We will use UNIFRAC algorithm to evaluate the null hypothesis that the structure of the microbial community is insensitive to cGVHD and symptoms of cGVHD. Differences in taxa are implicated by our high throughput sequencing methods will be confirmed by other techniques including culturing (where appropriate) and qPCR with taxa-specific primers.
Change in behavioral responses (symptoms) of individuals post allogeneic HSCT
Time frame: Baseline; Day 30; Day 100
6 secondary outcomes
Health Promoting Lifestyle Profile II (HPLPII)
Time frame: Baseline; Day 30; Day 100
Brief Pain Inventory (BPI)
Time frame: Baseline; Day 30; Day 100
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline; Day 30; Day 100
Brief Fatigue Inventory (BFI)
Time frame: Baseline; Day 30; Day 100
Memorial Symptom Assessment Scale (MSAS-SF)
Time frame: Baseline; Day 30; Day 100
Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT)
Time frame: Baseline; Day 30; Day 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Background: PubMed 26110573Kelly DL, Lyon DE, Yoon SL, Horgas AL. The Microbiome and Cancer: Implications for Oncology Nursing Science. Cancer Nurs. 2016 May-Jun;39(3):E56-62. doi: 10.1097/NCC.0000000000000286.
- Individual participant dataSharing planned: Undecided
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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.
Debra L Kelly, PhD, RN, OCN principal investigator
College of Nursing, University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplant (HSCT), run by University of Florida 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Sep 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT (time frame: Baseline; Day 30; Day 100). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03710031, which also lists 1 linked publication.
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 9 Sep 2021.