N/A
N=24
A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)
Hematologic Malignancy
Bottom Line
View on ClinicalTrials.gov: NCT03823651 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interval training (Behavioral); Psychiatric consult (Behavioral); Nutrition/diet evaluation (Behavioral); Referral to Social Worker (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions |
9 | — |
Summary
The purpose of this study is to evaluate the feasibility and outcomes of a research pre- and peri-transplant optimization program (R-PPOP) to improve multiple domains of health including physical function, cognitive function, mental health, and diet and nutrition for patients planning to undergo or undergoing hematopoietic stem cell transplantation (HCT).
Eligibility Criteria
Patient Inclusion Criteria:
- Plan to undergo an allogeneic hematopoietic stem cell transplant for any cancer or non-cancer illness within the next 6 months
- Age 18-80 years
Patient Exclusion Criteria:
- Both patient and caregiver are unable to read and follow directions in English (ok if only patient cannot read and follow directions in English as caregiver will be able to help).
- Any absolute contraindications to exercise:
- recent (< 6 months) acute cardiac event;
- unstable angina;
- uncontrolled dysrhythmias causing symptoms or hemodynamic compromise;
- symptomatic aortic stenosis;
- uncontrolled symptomatic heart failure;
- acute pulmonary embolus;
- acute myocarditis or pericarditis;
- suspected or known dissecting aneurism; or
- coronary artery disease.
- Functional impairment resulting in inability to exercise
Caregiver inclusion criteria
- Identified by patient as their primary caregiver
- Age 18-80 years
Caregiver exclusion criteria
- None
Data sourced from ClinicalTrials.gov (NCT03823651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.