Pilot Trial of Homebound Stem Cell Transplantation
Part of paid clinical trials in New York, New York.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT02671448
- Status
- Recruiting
Conditions
- Plasma Cell Dyscrasia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Accepted
Interventions
- Home monitoring teleconsult visits — BEHAVIORALA 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.
- Patient Reported Outcomes (PRO) — BEHAVIORALDistress Thermometer, MSK-Modified M.D. Anderson Symptom Inventory (MDASI) Instrument, FACT-G Instrument, FACT-BMT Instrument
- Caregiver Reported Outcomes instruments — BEHAVIORALDistress Thermometer, Caregiver Reaction Assessment (CRA) Instrument, The Caregiver Quality of Life Index-Cancer (CQOLC) Scale, Satisfaction Questionnaire, Video Diary Entries
Study Details
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).
Key Dates
- Start date
- Jan 31, 2016
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 91 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SCREENING
Arms
- Experimental: Homebound After Stem Cell TransplantationThe primary research outputs and measurements are the instruments/surveys, assessments, and video diaries to be completed by the patients, their caregivers and the healthcare providers during the time of the home transplantation care. Protocol-specific interventions during homebound care will continue until patient has achieved neutrophil engraftment. Post engraftment, standard of care practice will resume. Once discharged from homebound care, the patient will complete routine post-HSCT follow-up visits in the clinic setting.
Primary Outcome Measure
readmission rate by 21 days post HSCT [ Time Frame: 21 days post HSCT ]
Central Contacts
- Heather Landau, MD
- Sergio Giralt, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Heather Landau, MD Sergio Giralt, MD Heather Landau, MD (PRINCIPAL_INVESTIGATOR) |
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