A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 17-010255
Sponsor Protocol Number: 17-010255
About this study
The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients ≥ 18 years old, undergoing aHSCT or receiving chemotherapy for AML/ALL with absolute neutrophil count (ANC) <500 cells/µL with an anticipated hospital stay of greater than 2 weeks.
Exclusion Criteria:
- Active infection requiring antibiotics, fever any time during admission, patients requiring ICU admissions, patients admitted for reasons other than bone marrow transplant or induction chemotherapy for ALL/AML.
- Other important variables that will be measured:
- Age
- Sex
- Admission diagnosis
- Baseline Performance Status (ECOG score) and body mass index
- Type of chemotherapy/conditioning regimen: reduced intensity/myeloablative
- Duration of severe neutropenia
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Prakash Vishnu, M.B.B.S. |
Contact us for the latest status |
Contact information:
Candice Baldeo M.B.B.S.
(904)953-2000
Contact UsBaldeo.Candice@mayo.edu
|
More information
Publications
Publications are currently not available