Hematopoietic and Lymphoid Cell NeoplasmNCT04557709
Major Complication Rate in Cancer Patients With Neutropenic Fever Potentially Eligible for a Hospital at Home Program
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center.
Trial summary
This study investigates the major complication rate in cancer patients potentially eligible for a hospital at home program for management of neutropenic fever. "Hospital at Home" is a home care program that provides acute, inpatient care in a patient's home in place of a traditional hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Medical Chart Review
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Jul 2020to 18 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019
Who may be able to join
- Admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019
- Be at low risk for major complications as defined by a Multinational Association for Supportive Care in Cancer (MASCC) score < 21
Who cannot join
- Reside in a nursing home
- Homelessness
- Hospice enrollment
- A secondary reason for admission to the hospital or high risk clinical feature not captured in the MASCC score that places them at high risk for major complications in a hospital at home program
About this study
Official title: A Descriptive Study of Major Complications in Oncology Patients With Neutropenic Fever Potentially Eligible for a Hospital at Home Program
This study investigates the major complication rate in cancer patients potentially eligible for a hospital at home program for management of neutropenic fever. "Hospital at Home" is a home care program that provides acute, inpatient care in a patient's home in place of a traditional hospital stay. Learning more about the characteristics of potentially eligible patients, including reasons for inpatient admission, rates of major complications, and situations or treatments that would be difficult to deliver in an at home setting may help to inform future program development.
Read the detailed description
PRIMARY OBJECTIVE:
- Estimate the major complication rate among patients potentially eligible for a hospital at home program for management of neutropenic fever.
SECONDARY OBJECTIVES:
- Describe the demographic and clinical characteristics of patients potentially eligible for admission to a hospital at home program for management of neutropenic fever.
II. Describe situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home program (e.g., blood transfusions, echocardiograms, computed tomography [CT] scans).
OUTLINE:
Patients' medical charts are reviewed.
- Being tested
- Medical Chart Review
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart ReviewOther
Also called Chart Review
Review of medical charts
| Study group | Role | What they receive |
|---|---|---|
| Observational (chart review) | Patients' medical charts are reviewed. Receives: Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who experience major complications that require escalated care
Percentages will be presented with exact binomial 95% confidence interval. Also, will identify significant predictors of major complications (yes or no) using univariable logistic regression.
Measured: 1 month
Secondary outcomes (2)
Patient demographic, clinical, and psychosocial features
Will describe the study sample demographic, clinical, and psychosocial features. Descriptors will include frequencies, percentages, means with standard deviations, or medians with interquartile ranges, and minimum and maximum values as appropriate.
Measured: 1 month
Situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home (HaH) program
Will enumerate situations and treatments observed in the study sample that could not be handled optimally in the HaH environment.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start13 Jul 2020
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Why it stopped: 0 participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tacara N Soones, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557709
- Sponsor's protocol ID
- 2020-0394
- Other IDs
- NCI-2020-06606, 2020-0394
- Status last verified
- Aug 2025
- First submitted
- 15 Sep 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study of Major Complications in Oncology Patients With Neutropenic Fever Potentially Eligible for a Hospital at Home Program
- ClinicalTrials.gov ID
- NCT04557709
- Acronym / sponsor ID
- 2020-0394
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 0 participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the major complication rate in cancer patients potentially eligible for a hospital at home program for management of neutropenic fever. "Hospital at Home" is a home care program that provides acute, inpatient care in a patient's home in place of a traditional hospital stay. Learning more about the characteristics of potentially eligible patients, including reasons for inpatient admission, rates of major complications, and situations or treatments that would be difficult to deliver in an at home setting may help to inform future program development.
Detailed description
PRIMARY OBJECTIVE:
- Estimate the major complication rate among patients potentially eligible for a hospital at home program for management of neutropenic fever.
SECONDARY OBJECTIVES:
- Describe the demographic and clinical characteristics of patients potentially eligible for admission to a hospital at home program for management of neutropenic fever.
II. Describe situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home program (e.g., blood transfusions, echocardiograms, computed tomography [CT] scans).
OUTLINE:
Patients' medical charts are reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (chart review) | – | Other: Medical Chart ReviewPatients' medical charts are reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019
Key inclusion criteria (2 listed)
- Admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019
- Be at low risk for major complications as defined by a Multinational Association for Supportive Care in Cancer (MASCC) score < 21
Key exclusion criteria (4 listed)
- Reside in a nursing home
- Homelessness
- Hospice enrollment
- A secondary reason for admission to the hospital or high risk clinical feature not captured in the MASCC score that places them at high risk for major complications in a hospital at home program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewReview of medical charts | Other | Observational (chart review) |
Primary outcome
Percentage of patients who experience major complications that require escalated care
Time frame: 1 month
Percentages will be presented with exact binomial 95% confidence interval. Also, will identify significant predictors of major complications (yes or no) using univariable logistic regression.
2 secondary outcomes
Patient demographic, clinical, and psychosocial features
Time frame: 1 month
Situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home (HaH) program
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tacara N Soones principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who experience major complications that require escalated care (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.