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

NCT03870750 | Terminated Phase 2

• 4 other identifiers: RG1004746NCI-2019-010979885R01CA227092
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Non-Neoplastic Hematologic and Lymphocytic Disorder; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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.

  First 90 days after HCT

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

  At 1 year after HCT

• Change in HRQOL (Phase III)

  Will be measured by the FACT-BMT.

  Baseline to 90 days post-HCT

Secondary Outcomes (11)

• Rate of overall survival

  Up to 1 year

• Non-relapse mortality

  At 90 days and up to 1 year

• Cumulative incidence of relapse

  Up to 1 year

• Relapse-free survival

  Up to 1 year

• Cumulative incidence of frailty

  Up to 1 year

Study Arms (4)

Arm I (SPC)

EXPERIMENTAL

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.

Other: Supportive Palliative Care; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration

Arm II (CMC)

EXPERIMENTAL

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.

Other: Clinical Management; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration

Arm III (SPC and CMC)

EXPERIMENTAL

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.

Other: Supportive Palliative Care; Other: Clinical Management; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration

Arm IV (standard of care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration

Interventions

Supportive Palliative Care OTHER

focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects

Also known as: Comfort Care, palliation, palliative care, palliative therapy, Palliative Treatment, Symptom Management, Symptoms Management, PA-Palliative Therapy

Arm I (SPC); Arm III (SPC and CMC)

Clinical Management OTHER

physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education

Arm II (CMC); Arm III (SPC and CMC)

Best Practice OTHER

Given standard of care

Also known as: standard of care, standard therapy

Arm IV (standard of care)

Allogeneic Hematopoietic Stem Cell Transplantation PROCEDURE

Undergo HCT

Also known as: Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT, Stem Cell Transplantation

Arm I (SPC); Arm II (CMC); Arm III (SPC and CMC)

Questionnaire Administration OTHER

Ancillary studies

Arm I (SPC); Arm II (CMC); Arm III (SPC and CMC); Arm IV (standard of care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (SPC); Arm II (CMC); Arm III (SPC and CMC); Arm IV (standard of care)

Survey Administration OTHER

Complete surveys

Arm I (SPC); Arm II (CMC); Arm III (SPC and CMC); Arm IV (standard of care)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (11)

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Northwell Health Cancer Institute

New Hyde Park, New York, 11042, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Palliative Care; Patient Comfort; Practice Guidelines as Topic; Standard of Care; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation; Surgical Procedures, Operative

Study Officials

• Mohamed Sorror, MD, MSc

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: August 15, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)