A Multidisciplinary Approach to Improve the Health of Older Adults With Blood Cancers After Stem Cell Transplantation

City of Hope

Status: Active, not recruiting

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Treatments: Other: Health Promotion; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04914338

NCI-2021-03939 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

21026 (Other Identifier)

Details and patient eligibility

About

This clinical trial studies the usefulness and process of a multidisciplinary intervention, where patients see multiple healthcare professionals, aimed at improving fitness and the ability to bounce back after transplant for older adults with blood cancers planned for stem cell transplantation. Using a multidisciplinary team approach may increase patients' ability to withstand the transplant by optimizing health to better prepare patients for the expected complications after stem cell transplantation.

Full description

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of delivering a geriatric assessment guided by a multi-disciplinary team (MDT) intervention before allogeneic hematopoietic cell transplantation (HCT) in older patients.

SECONDARY OBJECTIVES:

I. Establish successful dose intensity of resiliency bolstering. II. Describe HCT utilization among enrolled patients. III. Create a standardized and exportable library of MDT-facilitated interventions.

IV. Estimate the benefit derived from the MDT approach compared to historic controls for day +100 outcomes of falls, delirium and functional decline.

V. Quantify early functionally independent survival (FIS) to estimate HCT-associated health span decline.

EXPLORATORY OBJECTIVES:

I. Characterize reasons patients do not undergo HCT after MDT intervention. II. Associate early FIS with 1-year non-relapse mortality (NRM) and overall survival (OS).

III. Integrate virtual assessment and interventions. IV. Correlate image defined sarcopenia with objective function. V. Biobank blood and stool for future studies of accelerated aging.

OUTLINE:

Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT.

After completion of study, patients are followed up for up to 1 year.

Enrollment: 40 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented informed consent of the participant
• >= 65 years at time of planned HCT infusion
• Anticipated to be candidate for allogeneic transplant per treating physician at the time of enrollment
• Ability to read English, Spanish or Mandarin. Other languages will be acceptable with principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures
• Any conditioning regimen and allogeneic donor permitted
• Hematologic malignancy or disease as indication for HCT
• Willing and able to complete study requirements

Exclusion criteria

• Prior allogeneic stem cell transplant
• Syngeneic donors for HCT
• Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Supportive care (MDT-intervention)

Experimental group

Description:

Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Health Promotion