N/A
Completed N=711
Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902)
Physiological Stress
Source: ClinicalTrials.gov NCT01278927 ↗
Enrolled (actual)
711
Serious AEs
0.1%
Results posted
Dec 2015
Primary outcomePrimary: Functional Status — 42.2; 41.8; 40.6; 42.5 units on a scale
Summary
This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The purpose of this study is to test whether exercise or stress management training delivered to autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to transplantation can improve functional status and the transplant experience.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Status |
42.2; 41.8; 40.6; 42.5; 50.8; 52.4 | — |
| SECONDARY Symptoms |
66.46; 66.12; 65.83; 67.38; 54.79; 53.49 | — |
| SECONDARY Cancer and Treatment Distress (CTXD) |
0.96; 0.88; 1.04; 0.94 | — |
| SECONDARY The Pittsburgh Sleep Quality Index (PSQI) |
4.55; 3.49; 4.44; 4.02 | — |
| SECONDARY Nausea |
2.74; 2.63; 2.80; 2.85 | — |
| SECONDARY Days of Hospitalization |
21.1; 22.7; 21.6; 20.9 | — |
| SECONDARY SF-36 Late Outcomes |
44.5; 42.3; 43.4; 42.8; 51.6; 52.5 | — |
| SECONDARY Survival |
89; 89; 86; 92; 85; 82 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Able to speak and read English
- Able to exercise at low to moderate intensity - adequate cardiopulmonary reserve, as judged by self-reported ability to walk up one flight of stairs, no requirement for supplemental oxygen, and physician judgment
- Willing and able to provide informed consent.
- Stated willingness to comply with study procedures and reporting requirements
- Planned autologous or allogeneic transplantation within 6 weeks.
Exclusion Criteria
- Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence
- Participation in another clinical trial with quality of life or functional status as a primary endpoint
Data sourced from ClinicalTrials.gov (NCT01278927). 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. Informational only — not medical advice.