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

Duke University

Status: Enrolling

Conditions: Well-being of Caregivers (Caregiver Strain Index)

Treatments: Other: home care

Study type: Interventional

Funder types: Other

Identifiers

NCT03667599

Pro00089697

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Home care

Experimental group

Description:

This is the arm for patients who receive their transplant care in their homes.

Treatment:

Other: home care

Hospital Care

No Intervention group

Description:

Standard of care for stem cell transplant recipients where the aftercare is done in hospital.

Clinic Care

No Intervention group

Description:

Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.