Developing Self-Management Interventions After HCT

University of Florida

Status: Completed

Conditions: Hematopoietic Stem Cell Transplant (HSCT)

Treatments: Other: PNS Tracking

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03710031

OCR18772 (Other Identifier)

IRB201802329

R21NR017749 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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).

Enrollment: 49 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

49 participants in 1 patient group

HSCT Survivors

Description:

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.

Treatment:

Other: PNS Tracking