NCT03710031

Developing Self-Management Interventions After HCT

Developing the Bio-behavioral Foundation for Self-Management of Psycho-neurological Symptoms in Hematopoietic Cell Transplant (HCT) Survivors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hematopoietic Stem Cell Transplant (HSCT)

Interventions

Type	Name	Description
OTHER	PNS Tracking	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).

Timeline

• Start date: 2019-02-04
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2018-10-17
• Last updated: 2021-09-09

Locations

1 site across 1 country: United States