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Clinical Trials/NCT04914338
NCT04914338
Active, Not Recruiting
N/A

Feasibility of a Multidisciplinary Approach to Circumvent Healthspan Decline After Allogeneic Hematopoietic Cell Transplantation in Older Patients

City of Hope Medical Center1 site in 1 country40 target enrollmentJune 3, 2021

Overview

Phase
N/A
Intervention
Health Promotion
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Sponsor
City of Hope Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)
Status
Active, Not Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 3, 2021
End Date
February 2, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

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

Arms & Interventions

Supportive care (MDT-intervention)

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.

Intervention: Health Promotion

Supportive care (MDT-intervention)

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.

Intervention: Quality-of-Life Assessment

Supportive care (MDT-intervention)

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.

Intervention: Questionnaire Administration

Outcomes

Primary Outcomes

Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)

Time Frame: Up to 1 year

Patients are expected to see 6 providers. Success is defined as enrolled patients seen at least 4 out of six providers. The study will meet feasibility endpoint if 90 percent or more of the enrolled patients are flagged as successful. Each patient will be measured as success or failure according to these rules.

Secondary Outcomes

  • Rate of hematopoietic cell transplantation (HCT) utilization(Up to 1 year)
  • Dose intensity of resiliency bolstering(Up to 1 year)
  • Library of MDT-facilitated intervention(Up to 1 year)
  • Functional independent survival (FIS)(Days 30, 60, 100)

Study Sites (1)

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