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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Active, not recruiting; Phase 3; Phase 2

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03870750

NCI-2019-01097 (Registry Identifier)

R01CA227092 (U.S. NIH Grant/Contract)

9885 (Other Identifier)

RG1004746

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 458 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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458 participants in 4 patient groups

Arm I (SPC)

Experimental group

Description:

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.

Treatment:

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

Other: Questionnaire Administration

Other: Supportive Palliative Care

Other: Quality-of-Life Assessment

Other: Survey Administration

Arm II (CMC)

Experimental group

Description:

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.

Treatment:

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

Other: Clinical Management

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Survey Administration

Arm III (SPC and CMC)

Experimental group

Description:

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.

Treatment:

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

Other: Clinical Management

Other: Questionnaire Administration

Other: Supportive Palliative Care

Other: Quality-of-Life Assessment

Other: Survey Administration

Arm IV (standard of care)

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Survey Administration

Other: Best Practice