A Multidisciplinary Approach to Improve the Health of Older Adults With Blood Cancers After Stem Cell Transplantation
Primary Purpose
Hematopoietic and Lymphoid Cell Neoplasm
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Promotion
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm
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
Sites / Locations
- City of Hope Nedical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (MDT-intervention)
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Rate of hematopoietic cell transplantation (HCT) utilization
Measured by summarizing proportion of patients proceeding to allogeneic HCT.
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".
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.
Full Information
NCT ID
NCT04914338
First Posted
May 24, 2021
Last Updated
August 14, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04914338
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (MDT-intervention)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Health Promotion
Other Intervention Name(s)
Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, Salutogenesis
Intervention Description
Participate in MDT-intervention
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Dose intensity of resiliency bolstering
Description
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).
Time Frame
Up to 1 year
Title
Rate of hematopoietic cell transplantation (HCT) utilization
Description
Measured by summarizing proportion of patients proceeding to allogeneic HCT.
Time Frame
Up to 1 year
Title
Library of MDT-facilitated intervention
Description
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".
Time Frame
Up to 1 year
Title
Functional independent survival (FIS)
Description
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.
Time Frame
Days 30, 60, 100
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew S Artz
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Nedical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Multidisciplinary Approach to Improve the Health of Older Adults With Blood Cancers After Stem Cell Transplantation
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