Developing Self-Management Interventions After HCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-04

Study Completion Date

2021-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Positive Psychology Intervention In HSCT

NCT05147311

Hematologic Malignancy Hematopoietic/Lymphoid Cancer Blood Cancer

COMPLETED NA

Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)

NCT03042715

Stem Cell Transplant Complications

COMPLETED

Intervention for Fatigue in HCT Recipients

NCT05715047

Hematologic Cancer Hematologic Malignancy

RECRUITING NA

In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients

NCT03859765

Stem Cell Transplant

COMPLETED NA

Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

NCT06328127

Hematopoietic Stem Cell Transplant

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hematopoietic Stem Cell Transplant (HSCT)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

PNS Tracking

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No