Pilot Trial of Homebound Stem Cell Transplantation

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02671448
Collaborator
(none)
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Study Details

Study Description

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 Phase
  • Behavioral: Home monitoring teleconsult visits
  • Behavioral: Patient Reported Outcomes (PRO)
  • Behavioral: Caregiver Reported Outcomes instruments

Study Design

Study Type:
Observational
Anticipated Enrollment :
91 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pilot Trial of Homebound Stem Cell Transplantation
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Heather Landau, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02671448
Other Study ID Numbers:
  • 15-022
First Posted:
Feb 2, 2016
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022