Improve Outcomes for Older Allogeneic Transplant Recipients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A (Prehab) 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. |
Behavioral: Exercise Program (Cohort A Prehab)
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.
|
| Experimental: Cohort B (Rehab) 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. |
Behavioral: Exercise Program (Cohort B Rehab)
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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of enrolled subjects who participate in the supervised exercise program [From 3 months prior to HCT to 100 days after HCT]
- Median number of exercise sessions delivered pre-HCT and post-HCT. [From 3 months prior to HCT to 100 days after HCT]
Secondary Outcome Measures
- Hospital LOS for HCT [From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months]
- Rate of readmission [From time of discharge from initial hospital stay up through 1-2 years after HCT]
- 6-month and 1-year overall mortality [From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS]
- 1-year and 2-year OS [From day 0 of HCT to 1-year and 2-years]
- 1-year and 2-year PFS [From day 0 of HCT to 1-year and 2-years]
Eligibility Criteria
Criteria
Inclusion Criteria:
Cohort A (Prehab)
-
Age 60 years or older.
-
Planned allogeneic HCT in the next 1-6 months.
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Hematological malignancy as the indication for HCT.
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Pre-frail or frail by Fried frailty phenotype.
Cohort B (Rehab)
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Age 60 years or older.
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Planned allogeneic HCT or HCT within the last 30 days.
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Hematological malignancy as the indication for HCT.
Exclusion Criteria:
Cohorts A and B
- Comorbid disability or illness that prevents safe exercise.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn Medicine | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
- Principal Investigator: Shannon McCurdy, MD, Penn Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 07422
- Penn IRB# 851615