Pilot Trial of Homebound Stem Cell Transplantation
ConditionPlasma Cell Dyscrasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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
This trial accepts healthy volunteersQualifiers
Diagnosis of Plasma cell dyscrasia
Treatment plan including Autologous HSCT
18-80 years of age
Lodging at the MSK Residence.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
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
Treatment groups
91 Participants
are divided into 1 treatment groupGroup A: Homebound After Stem Cell TransplantationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
readmission rate by 21 days post HSCT
the homebound procedure will be considered promising if no more than 10 patients are readmitted to the hospital within 21 days.
Time frame
21 days post HSCTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov