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Home Care or Hospital Care after Stem Cell Transplant in Participants with Cancer or Non-cancer Illness
Trial Status: active
This phase II trial studies how well home care or hospital care works after stem cell transplant in participants with cancer or non-cancer illness. Receiving after-transplant care at home may help to decrease the development of graft-versus-host-disease and may improve clinical outcomes such as survival.
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 >= 70
Able to read and 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
*Note: Patients who have relocated to Duke for their hematopoietic cell transplantation (HCT) and are staying in temporary lodging (such as a nearby apartment) may also be included in the “home care” arm of this study; therefore, from here on in the protocol, references to patients receiving “home care” may also be referring to patients receiving care in temporary lodging
CAREGIVER: Identified by patient as their primary caregiver
CAREGIVER: Meet standard clinical criteria for being a caregiver (able to drive and take care of patient)
CAREGIVER: Age 18-80 years
Exclusion Criteria
Lack of a caregiver
Pregnancy
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03667599.
I. To compare the quality of life (Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT]) in patients receiving home versus (vs) standard care after autologous hematopoietic stem cell transplant.
SECONDARY OBJECTIVES:
I. Compare additional clinical endpoints to include: overall survival, disease-free survival, rates of bacterial, fungal, and viral infections as well as overall infections, rates of hospital admission, transplant length of stay, return to work, quality of life (QOL) as assessed by the European Quality of Life Five Dimension Five Level (EQ-5D-5L), patient symptoms as assessed by the MD Anderson Symptom Inventory (MDASI) and Patient Reported Outcomes Measurement Information System (PROMIS) Depression and Anxiety.
II. Compare additional mediators of outcomes to include: social support as assessed by the Medical Outcomes Study Social Support Survey (MOS-SSS), nutrition as assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) and Automated Self-Administered 24-Hour (ASA24), hand grip testing, exercise as assessed by the activity diary, 6 minute walk test, ability to “do for oneself” as assed by the Lorig, changes in the gut and skin flora (microbiome).
III. Compare safety to include treatment-related mortality (TRM), adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
IV. Compare effects on caregivers and how caregiver outcomes impact patient outcomes caregiver QOL, health resource utilization, indirect costs (patients’ and caregivers’ time).
V. Compare costs to include direct medical costs, health resource utilization, indirect costs (patients’ and caregivers’ time).
OUTLINE: Participants are randomized into 1 of 2 arms.
ARM I: Participants receive standard of care from advanced practice providers (APPs) at hospital until suitable for discharge as determined by standard clinical criteria.
ARM II: Participants receive standard of care from APPs at home and have daily videoconferences with their physicians until suitable for discharge as determined by standard clinical criteria.
After completion of study, participants are followed up for at least 1 year and then periodically.
