Allogeneic Transplantation
Conditions
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.
Interventions
BEHAVIORALExercise 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.
BEHAVIORALExercise 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.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort A (Prehab) 1. Age 60 years or older. 2. Planned allogeneic HCT in the next 1-6 months. 3. Hematological malignancy as the indication for HCT. 4. Pre-frail or frail by Fried frailty phenotype. Cohort B (Rehab) 1. Age 60 years or older. 2. Planned allogeneic HCT or HCT within the last 30 days. 3. Hematological malignancy as the indication for HCT.
Exclusion criteria
Cohorts A and B 1\. Comorbid disability or illness that prevents safe exercise.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Hospital LOS for HCT | From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months |
| 1-year and 2-year PFS | From day 0 of HCT to 1-year and 2-years |
| 1-year and 2-year OS | From day 0 of HCT to 1-year and 2-years |
| Rate of readmission | From time of discharge from initial hospital stay up through 1-2 years after HCT |
Countries
United States
Contacts
Primary ContactJacqui Rick
Outcome results
None listed