Pilot Trial of Homebound Stem Cell Transplantation

NCT ID: NCT02671448

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2027-01-31

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).

Conditions

Plasma Cell Dyscrasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING

Study Groups

Homebound After Stem Cell Transplantation

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.

Group Type: EXPERIMENTAL

Home monitoring teleconsult visits

Intervention Type: 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)

Intervention Type: BEHAVIORAL

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

Caregiver Reported Outcomes instruments

Intervention Type: BEHAVIORAL

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

Interventions

Home 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.

Intervention Type: BEHAVIORAL

Patient Reported Outcomes (PRO)

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

Intervention Type: BEHAVIORAL

Caregiver Reported Outcomes instruments

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Landau, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heather Landau, MD

Role: CONTACT

ABMTTrials@mskcc.org

Sergio Giralt, MD

Role: CONTACT

ABMTTrials@mskcc.org

Facility Contacts

Heather Landau, MD

Role: primary

ABMTTrials@mskcc.org

Sergio Giralt, MD

Role: backup

ABMTTrials@mskcc.org

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

15-022

Identifier Type: -

Identifier Source: org_study_id