Clinical trial NCT02671448: Pilot Trial of Homebound Stem Cell Transplantation
Official title: Pilot Trial of Homebound Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plasma Cell Dyscrasia
Keywords: Homebound
Homecare
15-022
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot trial will be the first attempt at developing a homebound hematopoietic stem cell transplant (HSCT) program at MSK.
Primary purpose: SCREENING

Brief summary: In this study, the investigators plan to see what happens when a person receives care in the home setting. They want to find out if caring for a patient who has been treated with an ASCT in the home setting is feasible. They want to find out what effects good and/or bad this will have on the patient's recovery and treatment after ASCT. Studies in other institutions have shown that providing care in the home setting after ASCT is safe, increases patient satisfaction, and can decrease the risk of infection. It is our hope that this new approach of providing care in the home setting will prove to be a feasible and safe option for patients at Memorial Sloan Kettering Cancer Center (MSK).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Plasma cell dyscrasia
* Treatment plan including Autologous HSCT
* 18-80 years of age
* Appropriate homebound setting as defined by one of the following:

  * Lodging at the MSK Residence.
  * Staying at home or a "home equivalent" in any one of the zip codes as outlined in the appendix. Home equivalent is defined as a residence which may or may not be the primary residence of the patient.
  * "Home equivalent" must pass the "Home Environment Screening Tool" for homebound stem cell transplantation (not required for other MSK recognized lodging facility).
* Adequate caregiver support as defined by:

  * Single or multiple informal caregivers willing and able to provide 24 hour a day, seven day a week supervision of the transplant recipient in their home or "home-like" environment.
  * Caregiver willing and able to fulfill the basic stem cell transplant caregiver education requirements as determined by caregiver and healthcare team, including social worker
* Have Wi-Fi connection
* Appropriate third party payer coverage for "Homebound Stem Cell Transplant Program"
* Both patient and caregiver willing to give and sign informed consent.

Exclusion Criteria:

* Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
* Uncontrolled arrhythmias
* Active or uncontrolled pulmonary disease
* Karnofsky Performance Scale (KPS) score \<80
* Sorror Co-morbidity index ≥ 4 except in patients with history of resected cancers
* Creatinine clearance (calculated or measured) of \< 50 cc/minute
* Inability of patient or caregiver to speak or read English (we currently do not have the manpower to translate nor staff a multilingual homebound stem cell transplant program with adequate educational materials).
* Inadequate housing arrangements
* Inadequate caregiver arrangements

Primary outcomes:
measure: readmission rate by 21 days post HSCT
timeFrame: 21 days post HSCT
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heather Landau, MD
role: PRINCIPAL_INVESTIGATOR
References: