Well-being of Caregivers (Caregiver Strain Index)NCT03667599
A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
A study testing home care in people with Well-being of Caregivers (Caregiver Strain Index), run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Well-being of Caregivers (Caregiver Strain Index)
- What is being tested?
- home care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2018to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Anthony Sung, MD, 919-668-5710, anthony.sung@duke.edu
About this study
Official title: 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.
- Being tested
- home care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home careOther
This is the interventional arm where patients receive the transplant care in their homes.
| Study group | Role | What they receive |
|---|---|---|
| Home care | Experimental | This is the arm for patients who receive their transplant care in their homes. Receives: Other: home care |
| Hospital Care | No intervention | Standard of care for stem cell transplant recipients where the aftercare is done in hospital. |
| Clinic Care | No intervention | Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life in Caregivers (Caregiver Strain Index)
To compare the quality of life (Caregiver Strain Index) in caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.
Measured: 14 days
Secondary outcomes (38)
Measuring Caregiver Burden as recorded in a Time Diary
Measured: 1 year
Measuring Caregiver Self-Efficacy assessed by the Modified Lorig
Measured: 1 year
Measuring Caregiver Satisfaction assessed by Caregiver Satisfaction
Measured: 1 year
Measuring Caregiver Quality of Life as assessed by the FACT-GP
Measured: 1 year
Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health
Measured: 1 year
Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue
Measured: 1 year
Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep
Measured: 1 year
Measuring Caregiver Mental Health as assessed by the PROMIS-Depression
Measured: 1 year
Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety
Measured: 1 year
Measuring Return to Work in Caregivers (Work Assessment)
Measured: 1 year
Overall Survival
Measured: 1 year
Disease Free Survival
Measured: 1 year
Rates of Overall Infections
Measured: 1 year
Rates of Bacterial Infections
Measured: 1 year
Rates of Viral Infections
Measured: 1 year
Rates of Fungal Infections
Measured: 1 year
Rates of Hospital Admission
Measured: 1 year
Transplant Length of Stay
Measured: 1 year
Measuring Quality of Life as assessed by the EQ-5D-5L
Measured: 1 year
Measuring Symptoms as assessed by MDASI scale
Measured: 1 year
Measuring Self-Efficacy as assessed by the Lorig
Measured: 1 year
Measuring Fatigue as assessed by the PROMIS-Fatigue
Measured: 1 year
Measuring Fatigue as assessed by the PROMIS-Sleep
Measured: 1 year
Measuring Mental Health as assessed by the PROMIS-Anxiety
Measured: 1 year
Measuring Mental Health as assessed by the PROMIS-Depression
Measured: 1 year
Measuring Out-of-Pocket Costs as recorded in a Cost Diary
Measured: 1 year
Measuring Return to Work as assessed by the Work Assessment
Measured: 1 year
Measuring Social Support as assessed by the PROMIS-Social Isolation
Measured: 1 year
Measuring Nutrition as assessed by the PG-SGA
Measured: 30 days
Measuring Hand Grip Strength
Measured: 1 year
Measuring Exercise as assessed by 6 minute walk test
Measured: 1 year
Measuring Changes in fecal samples as measured by 16s rRNA sequencing
Measured: 1 year
Measuring Changes in the skin flora (microbiome)
Measured: 1 year
Measuring treatment related mortality (TRM)
Measured: 1 year
Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Measured: 1 year
Measuring Direct Medical Costs
Measured: 6 months
Measuring Health Resource Utilization using Duke University Health System (DUHS) records
Measured: 1 year
Measuring Indirect Costs (Patient's and Caregivers' Time)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start28 Sep 2018
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-being of Caregivers (Caregiver Strain Index)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Sung, MD, Principal investigator, Duke HealthNelson Chao, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667599
- Sponsor's protocol ID
- Pro00089697
- Status last verified
- Mar 2025
- First submitted
- 3 Jul 2018
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03667599
- Acronym / sponsor ID
- Pro00089697
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 12 Sep 2018 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home care | Experimental | Other: home careThis is the arm for patients who receive their transplant care in their homes. |
| Hospital Care | No intervention | –Standard of care for stem cell transplant recipients where the aftercare is done in hospital. |
| Clinic Care | No intervention | –Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| home careThis is the interventional arm where patients receive the transplant care in their homes. | Other | Home care |
Primary outcome
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.
38 secondary outcomes
Measuring Caregiver Burden as recorded in a Time Diary
Time frame: 1 year
Measuring Caregiver Self-Efficacy assessed by the Modified Lorig
Time frame: 1 year
Measuring Caregiver Satisfaction assessed by Caregiver Satisfaction
Time frame: 1 year
Measuring Caregiver Quality of Life as assessed by the FACT-GP
Time frame: 1 year
Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health
Time frame: 1 year
Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue
Time frame: 1 year
Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep
Time frame: 1 year
Measuring Caregiver Mental Health as assessed by the PROMIS-Depression
Time frame: 1 year
Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety
Time frame: 1 year
Measuring Return to Work in Caregivers (Work Assessment)
Time frame: 1 year
Overall Survival
Time frame: 1 year
Disease Free Survival
Time frame: 1 year
Rates of Overall Infections
Time frame: 1 year
Rates of Bacterial Infections
Time frame: 1 year
Rates of Viral Infections
Time frame: 1 year
Rates of Fungal Infections
Time frame: 1 year
Rates of Hospital Admission
Time frame: 1 year
Transplant Length of Stay
Time frame: 1 year
Measuring Quality of Life as assessed by the EQ-5D-5L
Time frame: 1 year
Measuring Symptoms as assessed by MDASI scale
Time frame: 1 year
Measuring Self-Efficacy as assessed by the Lorig
Time frame: 1 year
Measuring Fatigue as assessed by the PROMIS-Fatigue
Time frame: 1 year
Measuring Fatigue as assessed by the PROMIS-Sleep
Time frame: 1 year
Measuring Mental Health as assessed by the PROMIS-Anxiety
Time frame: 1 year
Measuring Mental Health as assessed by the PROMIS-Depression
Time frame: 1 year
Measuring Out-of-Pocket Costs as recorded in a Cost Diary
Time frame: 1 year
Measuring Return to Work as assessed by the Work Assessment
Time frame: 1 year
Measuring Social Support as assessed by the PROMIS-Social Isolation
Time frame: 1 year
Measuring Nutrition as assessed by the PG-SGA
Time frame: 30 days
Measuring Hand Grip Strength
Time frame: 1 year
Measuring Exercise as assessed by 6 minute walk test
Time frame: 1 year
Measuring Changes in fecal samples as measured by 16s rRNA sequencing
Time frame: 1 year
Measuring Changes in the skin flora (microbiome)
Time frame: 1 year
Measuring treatment related mortality (TRM)
Time frame: 1 year
Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: 1 year
Measuring Direct Medical Costs
Time frame: 6 months
Measuring Health Resource Utilization using Duke University Health System (DUHS) records
Time frame: 1 year
Measuring Indirect Costs (Patient's and Caregivers' Time)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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.
Anthony Sung, MD principal investigator
Duke Health
Nelson Chao, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home care in people with Well-being of Caregivers (Caregiver Strain Index), run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pires, MS (919-613-1546, andrea.pires@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in Caregivers (Caregiver Strain Index) (time frame: 14 days). 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 17 Mar 2025.