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Active, Not Recruiting

NCT Number: NCT02671448

Pilot Trial of Homebound Stem Cell Transplantation

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home monitoring teleconsult visits

Behavioral

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.

Patient Reported Outcomes (PRO)

Behavioral

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

Caregiver Reported Outcomes instruments

Behavioral

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

Primary outcomes

  1. readmission rate by 21 days post HSCT

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2016
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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