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

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04914338
• Other study ID #: 21026
• Secondary ID: NCI-2021-0393921
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Other:
• Health Promotion
Participate in MDT-intervention
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Nedical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)	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.	Up to 1 year
Secondary	Dose intensity of resiliency bolstering	Adequate dose intensity arbitrarily will be defined as completion of at least 11 of 16 process metrics (i.e, approximately 70 percent of more of process measures).	Up to 1 year
Secondary	Rate of hematopoietic cell transplantation (HCT) utilization	Measured by summarizing proportion of patients proceeding to allogeneic HCT.	Up to 1 year
Secondary	Library of MDT-facilitated intervention	Will provide a standardized library of evaluation and interventions from the MDT approach. A manual of procedures will be created and a database to capture metrics. Will be categorized by the MDT in a Likert scale to the following question: "Is the library of MDT-facilitated interventions ready to be exposure for a randomized controlled trial".	Up to 1 year
Secondary	Functional independent survival (FIS)	FIS will be calculated as with first observed failure events of intensive care unit admissions, delirium, falls, or frail 4 meter walk at day 30 or day 100. Functional impairment will use the milestones of day 30, day 60 day 100.	Days 30, 60, 100