Clinical trial NCT04914338: A Multidisciplinary Approach to Improve the Health of Older Adults With Blood Cancers After Stem Cell Transplantation
Official title: Feasibility of a Multidisciplinary Approach to Circumvent Healthspan Decline After Allogeneic Hematopoietic Cell Transplantation in Older Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Dose intensity of resiliency bolstering
timeFrame: Up to 1 year
measure: Rate of hematopoietic cell transplantation (HCT) utilization
timeFrame: Up to 1 year
measure: Library of MDT-facilitated intervention
timeFrame: Up to 1 year
measure: Functional independent survival (FIS)
timeFrame: Days 30, 60, 100
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Nedical Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Andrew S Artz
role: PRINCIPAL_INVESTIGATOR
References: