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Improve Outcomes for Older Allogeneic Transplant Recipients

Primary Purpose

Allogeneic Transplantation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program (Cohort A Prehab)
Exercise Program (Cohort B Rehab)
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allogeneic Transplantation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cohort A (Prehab) Age 60 years or older. Planned allogeneic HCT in the next 1-6 months. Hematological malignancy as the indication for HCT. Pre-frail or frail by Fried frailty phenotype. Cohort B (Rehab) Age 60 years or older. Planned allogeneic HCT or HCT within the last 30 days. Hematological malignancy as the indication for HCT. Exclusion Criteria: Cohorts A and B 1. Comorbid disability or illness that prevents safe exercise.

Sites / Locations

  • Penn MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A (Prehab)

Cohort B (Rehab)

Arm Description

Pre-frail and frail subjects will attend at least twice weekly exercise sessions with a physical therapist and be given an exercise program to complete at home prior to admission for HCT. Patients enrolled in this cohort can continue on to Cohort B.

All patients 60 years and older upon discharge from their initial hospital stay for HCT will attend at least weekly exercise sessions with a physical therapist and be given an exercise program to complete at home with sessions continued through Day +100 after HCT.

Outcomes

Primary Outcome Measures

Proportion of enrolled subjects who participate in the supervised exercise program
Median number of exercise sessions delivered pre-HCT and post-HCT.

Secondary Outcome Measures

Hospital LOS for HCT
Rate of readmission
6-month and 1-year overall mortality
1-year and 2-year OS
1-year and 2-year PFS

Full Information

First Posted
October 21, 2022
Last Updated
February 21, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05612789
Brief Title
Improve Outcomes for Older Allogeneic Transplant Recipients
Official Title
Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an interventional pilot study to determine whether implementation of a supervised exercise program can improve outcomes in subjects undergoing allogeneic HCT. The primary objective is to determine feasibility. Up to 60-72 evaluable subjects will be enrolled. Evaluable subjects are defined as those participating in the exercise intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allogeneic Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A (Prehab)
Arm Type
Experimental
Arm Description
Pre-frail and frail subjects will attend at least twice weekly exercise sessions with a physical therapist and be given an exercise program to complete at home prior to admission for HCT. Patients enrolled in this cohort can continue on to Cohort B.
Arm Title
Cohort B (Rehab)
Arm Type
Experimental
Arm Description
All patients 60 years and older upon discharge from their initial hospital stay for HCT will attend at least weekly exercise sessions with a physical therapist and be given an exercise program to complete at home with sessions continued through Day +100 after HCT.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program (Cohort A Prehab)
Intervention Description
Pre-frail and frail potential HCT recipients 60 years and older will participate in a supervised exercise program from the time of enrollment up until HCT admission. Exercise compliance will be measured in part through physical activity trackers.from time of discharge from HCT until day +100 post-HCT. All HCT recipients 60 years and older will participate in a supervised exercise program from the time of discharge from HCT admission until day +100 post-HCT. Exercise compliance will be measured in part through physical activity trackers.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program (Cohort B Rehab)
Intervention Description
All HCT recipients 60 years and older will participate in a supervised exercise program from the time of discharge from HCT admission until day +100 post-HCT. Exercise compliance will be measured in part through physical activity trackers.
Primary Outcome Measure Information:
Title
Proportion of enrolled subjects who participate in the supervised exercise program
Time Frame
From 3 months prior to HCT to 100 days after HCT
Title
Median number of exercise sessions delivered pre-HCT and post-HCT.
Time Frame
From 3 months prior to HCT to 100 days after HCT
Secondary Outcome Measure Information:
Title
Hospital LOS for HCT
Time Frame
From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months
Title
Rate of readmission
Time Frame
From time of discharge from initial hospital stay up through 1-2 years after HCT
Title
6-month and 1-year overall mortality
Time Frame
From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS
Title
1-year and 2-year OS
Time Frame
From day 0 of HCT to 1-year and 2-years
Title
1-year and 2-year PFS
Time Frame
From day 0 of HCT to 1-year and 2-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cohort A (Prehab) Age 60 years or older. Planned allogeneic HCT in the next 1-6 months. Hematological malignancy as the indication for HCT. Pre-frail or frail by Fried frailty phenotype. Cohort B (Rehab) Age 60 years or older. Planned allogeneic HCT or HCT within the last 30 days. Hematological malignancy as the indication for HCT. Exclusion Criteria: Cohorts A and B 1. Comorbid disability or illness that prevents safe exercise.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqui Rick
Phone
2152209675
Email
Jacqui.Rick@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon McCurdy, MD
Organizational Affiliation
Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqui Rick
Phone
215-220-9675
Email
Jacqui.Rick@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Improve Outcomes for Older Allogeneic Transplant Recipients

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