Clinical trial NCT03710031: Developing Self-Management Interventions After HCT
Official title: Developing the Bio-behavioral Foundation for Self-Management of Psycho-neurological Symptoms in Hematopoietic Cell Transplant (HCT) Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplant (HSCT)
Keywords: psychoneurological symptoms (PNS)
quality of life (QOL)
hematopoietic stem cell transplant (HSCT)
microbiota gut-brain axis
inflammation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-10-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT
timeFrame: Baseline; Day 30; Day 100
measure: Change in diversity and levels of fecal microbes of individuals post allogeneic HSCT
timeFrame: Baseline; Day 30; Day 100
measure: Change in behavioral responses (symptoms) of individuals post allogeneic HSCT
timeFrame: Baseline; Day 30; Day 100
Secondary outcomes:
measure: Health Promoting Lifestyle Profile II (HPLPII)
timeFrame: Baseline; Day 30; Day 100
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline; Day 30; Day 100
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline; Day 30; Day 100
measure: Brief Fatigue Inventory (BFI)
timeFrame: Baseline; Day 30; Day 100
measure: Memorial Symptom Assessment Scale (MSAS-SF)
timeFrame: Baseline; Day 30; Day 100
measure: Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT)
timeFrame: Baseline; Day 30; Day 100
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cancer Hospital
state: Florida
Study officials:
affiliation: College of Nursing, University of Florida
name: Debra L Kelly, PhD, RN, OCN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.