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

Status: closed to accrual

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.

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)

PRIMARY OBJECTIVES:

I. Compare in a randomized phase II study the effectiveness of supportive and palliative care, a clinical multi-modal program, or a combined approach versus usual care only (UCO) to determine the winning arm in improving health-related quality of life (HRQOL) (Day-90 Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT] scores) for vulnerable recipients of allogeneic hematopoietic cell transplantation (HCT). (Phase II)

II. Compare in a randomized phase III study the effectiveness of the winning arm from the preceding phase II study versus UCO in improving HRQOL (Day-90 FACT-BMT scores) and/or overall survival at 1-year for vulnerable recipients of allogeneic HCT. (Phase III)

SECONDARY OBJECTIVES:

I. Compare each of the three arms versus UCO regarding rates of overall survival. (Phase II and III)

II. Compare each of the three arms versus UCO regarding cumulative incidences of non-relapse mortality (NRM). (Phase II and III)

III. Compare each of the three arms versus UCO regarding cumulative incidences of relapse. (Phase II and III)

IV. Compare each of the three arms versus UCO regarding rates of relapse-free survival (RFS). (Phase II and III)

V. Compare each of the three arms versus UCO regarding cumulative incidence of frailty. (Phase II and III)

VI. Compare each of the three arms versus UCO regarding cumulative incidence of disability. (Phase II and III)

VII. Compare each of the three arms versus UCO regarding cumulative incidence of grades III-IV cardiac, hepatic, pulmonary and renal toxicities according to the Common Toxicity Criteria (CTC) version 4. (Phase II)

VIII. Compare each of the three arms versus UCO regarding use of resources within first 90 days after HCT: Frequency of hospitalization. (Phase II and III)

IX. Compare each of the three arms versus UCO regarding use of resources within first 90 days after HCT: Duration of each hospitalization. (Phase II and III)

X. Compare each of the three arms versus UCO regarding use of resources within first 90 days after HCT: Number and duration of admissions to intensive care unit. (Phase II and III)

XI. Compare each of the three arms versus UCO regarding use of resources within first 90 days after HCT: Days out of hospital alive (DOHA). (Phase II and III)

COST OF CANCER CARE OBJECTIVE:

I. Explore the effects of the supportive care and clinical management of comorbidities interventions on out-of-pocket costs in the six months after HCT.

OUTLINE: Patients are randomized to 1 of 4 arms.

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.

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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

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