A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation

March 13, 2025 updated by: Duke University

A Randomized Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation

This is a research study to compare the well-being (caregiver strain index) of caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Patient Inclusion Criteria:

  • Scheduled to undergo an autologous hematopoietic stem cell transplant for any cancer or non-cancer illness
  • Age 18-80 years
  • Karnofsky Performance Scale KPS> 80
  • Able to read/write English
  • A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke

Patient Exclusion Criteria:

  • Lack of a caregiver
  • Pregnant women
  • Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
  • Use of homeopathic medications, prebiotics, or probiotics that may impact gut microbiota

Caregiver Inclusion Criteria:

  • Identified by patient as their primary caregiver
  • Meet standard clinical criteria for being a caregiver (able to drive and take care of patient)
  • Age 18-80 years

Caregiver Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Home care
This is the arm for patients who receive their transplant care in their homes.
Other: home care
This is the interventional arm where patients receive the transplant care in their homes.
No Intervention: Hospital Care
Standard of care for stem cell transplant recipients where the aftercare is done in hospital.
No Intervention: Clinic Care
Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Life in Caregivers (Caregiver Strain Index)
Time Frame: 14 days
To compare the quality of life (Caregiver Strain Index) in caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival
Time Frame: 1 year
1 year
Disease Free Survival
Time Frame: 1 year
1 year
Measuring Caregiver Burden as recorded in a Time Diary
Time Frame: 1 year
1 year
Measuring Caregiver Self-Efficacy assessed by the Modified Lorig
Time Frame: 1 year
1 year
Measuring Caregiver Satisfaction assessed by Caregiver Satisfaction
Time Frame: 1 year
1 year
Measuring Caregiver Quality of Life as assessed by the FACT-GP
Time Frame: 1 year
1 year
Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health
Time Frame: 1 year
1 year
Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue
Time Frame: 1 year
1 year
Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep
Time Frame: 1 year
1 year
Measuring Caregiver Mental Health as assessed by the PROMIS-Depression
Time Frame: 1 year
1 year
Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety
Time Frame: 1 year
1 year
Measuring Return to Work in Caregivers (Work Assessment)
Time Frame: 1 year
1 year
Rates of Overall Infections
Time Frame: 1 year
1 year
Rates of Bacterial Infections
Time Frame: 1 year
1 year
Rates of Viral Infections
Time Frame: 1 year
1 year
Rates of Fungal Infections
Time Frame: 1 year
1 year
Rates of Hospital Admission
Time Frame: 1 year
1 year
Transplant Length of Stay
Time Frame: 1 year
1 year
Measuring Quality of Life as assessed by the EQ-5D-5L
Time Frame: 1 year
1 year
Measuring Symptoms as assessed by MDASI scale
Time Frame: 1 year
1 year
Measuring Self-Efficacy as assessed by the Lorig
Time Frame: 1 year
1 year
Measuring Fatigue as assessed by the PROMIS-Fatigue
Time Frame: 1 year
1 year
Measuring Fatigue as assessed by the PROMIS-Sleep
Time Frame: 1 year
1 year
Measuring Mental Health as assessed by the PROMIS-Anxiety
Time Frame: 1 year
1 year
Measuring Mental Health as assessed by the PROMIS-Depression
Time Frame: 1 year
1 year
Measuring Out-of-Pocket Costs as recorded in a Cost Diary
Time Frame: 1 year
1 year
Measuring Return to Work as assessed by the Work Assessment
Time Frame: 1 year
1 year
Measuring Social Support as assessed by the PROMIS-Social Isolation
Time Frame: 1 year
1 year
Measuring Nutrition as assessed by the PG-SGA
Time Frame: 30 days
30 days
Measuring Hand Grip Strength
Time Frame: 1 year
1 year
Measuring Exercise as assessed by 6 minute walk test
Time Frame: 1 year
1 year
Measuring Changes in fecal samples as measured by 16s rRNA sequencing
Time Frame: 1 year
1 year
Measuring Changes in the skin flora (microbiome)
Time Frame: 1 year
1 year
Measuring treatment related mortality (TRM)
Time Frame: 1 year
1 year
Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time Frame: 1 year
1 year
Measuring Direct Medical Costs
Time Frame: 6 months
6 months
Measuring Health Resource Utilization using Duke University Health System (DUHS) records
Time Frame: 1 year
1 year
Measuring Indirect Costs (Patient's and Caregivers' Time)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anthony Sung, MD, Duke Health
  • Principal Investigator: Nelson Chao, MD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00089697

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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