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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
Recruiting
I'm InterestedTrial ID: NCT03870750
Purpose
This phase II/III trial studies the best approach in improving quality of life and survival
after a donor stem cell transplant in older, weak, or frail patients with blood diseases.
Patients who have undergone a transplant often experience increases in disease and death. One
approach, supportive and palliative care (SPC), focuses on relieving symptoms of stress from
serious illness and care through physical, cultural, psychological, social, spiritual, and
ethical aspects. While a second approach, clinical management of comorbidities (CMC) focuses
on managing multiple diseases, other than cancer, such as heart or lung diseases through
physical exercise, strength training, stress reduction, medication management, dietary
recommendations, and education. Giving SPC, CMC, or a combination of both may work better in
improving quality of life and survival after a donor stem cell transplant compared to
standard of care in patients with blood diseases.
Official Title
Seamless Phase II-Phase III Randomized Clinical Trial to Identify and Confirm the Most Promising Novel Intervention to Alleviate Morbidity and Mortality After Allogeneic Hematopoietic Cell Transplantation Among Older, Medically Infirm, or Frail Patients With Hematological Diseases
Stanford Investigator(s)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Inclusion Criteria:
- Vulnerable patients as defined by one or more of the following 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:
- Orthopedic, neurologic or other problems which prevent safe ambulation and protocol
adherence. Information on prior falls and other recent orthopedic or neurologic
problems will be used to make judgment about protocol eligibility
- 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)
Intervention(s):
other: Supportive Palliative Care
other: Clinical Management
other: Best Practice
procedure: Allogeneic Hematopoietic Stem Cell Transplantation
other: Questionnaire Administration
other: Quality-of-Life Assessment
other: Survey Administration
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Melanie Gaudinez
650-725-4983