Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant in Older, Medically Infirm, or Frail Patients With Blood Diseases
NCT ID: NCT03870750
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
458 participants
INTERVENTIONAL
2019-08-15
2025-12-31
Brief Summary
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Detailed Description
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ARM I: Patients undergo SPC on days -15 before to +56 after transplant.
ARM II: Patients undergo a CMC program on days -15 before to +56 after transplant.
ARM III: Patients undergo interventions as outlined in Arm I and Arm II.
ARM IV: Patients receive standard of care.
In all arms, patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment and 30, 90, 180, and 365 days post HCT. In all arms patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (SPC)
Patients undergo SPC on days -15 before to +56 after transplant. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Supportive Palliative Care
focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HCT
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete surveys
Arm II (CMC)
Patients undergo a CMC program on days -15 to 56. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Clinical Management
physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HCT
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete surveys
Arm III (SPC and CMC)
Patients undergo interventions as outlined in Arm I and Arm II. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Supportive Palliative Care
focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects
Clinical Management
physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HCT
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete surveys
Arm IV (standard of care)
Patients receive standard of care. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Best Practice
Given standard of care
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete surveys
Interventions
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Supportive Palliative Care
focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects
Clinical Management
physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education
Best Practice
Given standard of care
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HCT
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete surveys
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 65 years or older
* Having Hematopoietic Cell Transplantation - Comorbidity Index (HCT-CI) scores of \>= 3 (for patients that could be 20 years old and older)
* Having frailty as determined by walk speed of \< 0.8 m/s using 4-meter walk test (for patients 50 years old and older)
* Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
* Able to speak and read English - interaction with the interventionist trainer and endpoint measurement must occur in English
* Willing and able to provide informed consent
* Planned allogeneic HCT within 3 weeks - all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g. suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant
* Able to exercise at low to moderate intensity, specifically taking into consideration the rare circumstances where subjects are not able to exercise due to either birth deformity or prior traumatic injury that affects their gait
* Adequate cardiopulmonary reserve, as judged by data from the patient's electronic medical record as to whether a patient could walk up one flight of stairs, no need for supplemental oxygen, and/or physician judgment
Exclusion Criteria
* Participation in another intervention clinical trial with HRQOL as a primary endpoint
* Planned donor lymphocyte infusion (DLI) within 90 days post-transplant
* Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol principal investigator (PI)
20 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mohamed Sorror, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
University of California San Francisco
San Francisco, California, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health Cancer Institute
New Hyde Park, New York, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2019-01097
Identifier Type: REGISTRY
Identifier Source: secondary_id
9885
Identifier Type: OTHER
Identifier Source: secondary_id
RG1004746
Identifier Type: -
Identifier Source: org_study_id
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