A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: home care.
- Who it may be relevant to
- Registry conditions: Well-being of Caregivers (Caregiver Strain Index). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
Overview
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.
Interventions
- Other home care
This is the interventional arm where patients receive the transplant care in their homes.
Primary outcome measures
- Quality of Life in Caregivers (Caregiver Strain Index) [Time frame: 14 days]
Secondary outcome measures (12)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT03667599 · Pro00089697