Developing the Bio-behavioral Foundation for Self-Management of Psycho-neurological Symptoms in Hematopoietic Cell Transplant (HCT) Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT
研究概览
简要总结
This is a prospective, longitudinal, observational trial to evaluate quality of life in hematopoietic stem cell transplant survivors.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT
时间窗: 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
时间窗: 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
时间窗: Baseline; Day 30; Day 100
次要结局
- Health Promoting Lifestyle Profile II (HPLPII)(Baseline; Day 30; Day 100)
- Brief Pain Inventory (BPI)(Baseline; Day 30; Day 100)
- Hospital Anxiety and Depression Scale (HADS)(Baseline; Day 30; Day 100)
- Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT)(Baseline; Day 30; Day 100)
- Brief Fatigue Inventory (BFI)(Baseline; Day 30; Day 100)
- Memorial Symptom Assessment Scale (MSAS-SF)(Baseline; Day 30; Day 100)