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Pilot Trial of Homebound Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671448
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Plasma Cell Dyscrasia Behavioral: Home monitoring teleconsult visits Behavioral: Patient Reported Outcomes (PRO) Behavioral: Caregiver Reported Outcomes instruments

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Trial of Homebound Stem Cell Transplantation
Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Behavioral: 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.

Behavioral: Patient Reported Outcomes (PRO)
Distress Thermometer, MSK-Modified M.D. Anderson Symptom Inventory (MDASI) Instrument, FACT-G Instrument, FACT-BMT Instrument

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Prior to study enrollment, MSK attending physicians and transplant coordinators will review the eligibility of new patients.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671448


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Heather Landau, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02671448    
Other Study ID Numbers: 15-022
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Homebound
Homecare
15-022
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders