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

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

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

Baldeo.Candice@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20423512

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