Developing Self-Management Interventions After HCT

NCT03710031 | Completed

• 3 other identifiers: IRB201802329R21NR017749OCR18772
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, longitudinal, observational trial to evaluate quality of life in hematopoietic stem cell transplant survivors.

Conditions

Hematopoietic Stem Cell Transplant (HSCT)

Keywords

psychoneurological symptoms (PNS); quality of life (QOL); hematopoietic stem cell transplant (HSCT); microbiota gut-brain axis; inflammation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Baseline; Day 30; Day 100

• Change in behavioral responses (symptoms) of individuals post allogeneic HSCT

  Baseline; Day 30; Day 100

Secondary Outcomes (6)

• 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

• Brief Fatigue Inventory (BFI)

  Baseline; Day 30; Day 100

• Memorial Symptom Assessment Scale (MSAS-SF)

  Baseline; Day 30; Day 100

Study Arms (1)

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.

Other: PNS Tracking

Interventions

PNS Tracking OTHER

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).

HSCT Survivors

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

UF Health Cancer Hospital

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• 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.

  PMID: 26110573 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiome: Stool, Cytokines and C-Reactive Protein: Blood.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Debra L Kelly, PhD, RN, OCN

  College of Nursing, University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 17, 2018
• Study Start: February 4, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

US (1)