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

Phase 3TerminatedNCT03870750

Fred Hutchinson Cancer Center458 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

458

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (11)

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

...and 1 more locations

Outcomes

Primary Outcomes

Improvement in health-related quality of life (HRQOL) (Phase II)

The arm with the largest mean change in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) from baseline to day 90. The Wilcoxon rank-sum test will be used to compare change in FACT-BMT between arms, and this will also be the test to be used in computation of the conditional power at the end of phase II.

Time frame: First 90 days after HCT

Survival after hematopoietic cell transplantation (HCT) (Phase III)

Time frame: At 1 year after HCT

Change in HRQOL (Phase III)

Will be measured by the FACT-BMT.

Time frame: Baseline to 90 days post-HCT

Secondary Outcomes

Rate of overall survival

Overall survival will be compared between each of the experimental arms and the usual care only (UCO) arm using the log-rank test. Arms that do not survive the screening phase will also be included for comparison.

Time frame: Up to 1 year

Non-relapse mortality

Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; analysis of variance (ANOVA) or Kruskal-Wallis test for comparisons involving more than two groups). Will use generalized estimating equations (GEEs) approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.

Time frame: At 90 days and up to 1 year

Cumulative incidence of relapse

Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.

Time frame: Up to 1 year

Relapse-free survival

Time frame: Up to 1 year

Cumulative incidence of frailty

Time frame: Up to 1 year

Cumulative incidence of disability

Time frame: Up to 1 year

Frequency of hospitalization