Pilot Trial of Homebound Stem Cell Transplantation

Not Applicable

Recruiting

• Conditions: Plasma Cell Dyscrasia
• Interventions: Behavioral: Home monitoring teleconsult visits; Behavioral: Patient Reported Outcomes (PRO); Behavioral: Caregiver Reported Outcomes instruments

• Registration Number: NCT02671448
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 91

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Homebound After Stem Cell Transplantation	Caregiver Reported Outcomes instruments	The 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.
Homebound After Stem Cell Transplantation	Patient Reported Outcomes (PRO)	The 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.
Homebound After Stem Cell Transplantation	Home monitoring teleconsult visits	The 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 Measures

Name	Time	Method
readmission rate by 21 days post HSCT	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States