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Pilot Trial of Homebound Stem Cell Transplantation

Pilot Trial of Homebound Stem Cell Transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02671448
Enrollment
83
Registered
2016-02-02
Start date
2016-01-01
Completion date
2027-01-01
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasma Cell Dyscrasia

Keywords

Homebound, Homecare, 15-022

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).

Interventions

BEHAVIORALHome monitoring teleconsult visits

A tablet will be provided to both the patient and the caregiver during the homecare portion of the study. The tablet will remain at the home, to be used by the patient and the caregiver during daily homecare visits to complete instruments/surveys and video diary recording sessions.

BEHAVIORALPatient Reported Outcomes (PRO)

Distress Thermometer, MSK-Modified M.D. Anderson Symptom Inventory (MDASI) Instrument, FACT-G Instrument, FACT-BMT Instrument

BEHAVIORALCaregiver Reported Outcomes instruments

Distress Thermometer, Caregiver Reaction Assessment (CRA) Instrument, The Caregiver Quality of Life Index-Cancer (CQOLC) Scale, Satisfaction Questionnaire, Video Diary Entries

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Intervention model description

This pilot trial will be the first attempt at developing a homebound hematopoietic stem cell transplant (HSCT) program at MSK.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
readmission rate by 21 days post HSCT21 days post HSCTthe homebound procedure will be considered promising if no more than 10 patients are readmitted to the hospital within 21 days.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHeather Landau, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026