Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04552912 |
| Other study ID # |
Pro00106590 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to test the efficacy of an evidence-based tailored physical
activity program adapted for adults with acute leukemia. Implementation-related process
evaluation of the physical activity program will also be assessed.
Description:
Rationale/Significance of Study: Acute leukemias (AL) are an aggressive and often
debilitating cancer with increasing incidence among those with a prior history of cancer and
older adults. Initial treatment is complex and even when remission is initially achieved,
there is a high risk for disease relapse. Research shows that individual characteristics such
as decreased physical function are associated with poor survival in AL. Intensive
chemotherapy remains the standard treatment necessary for survival. Chemotherapy
administration entails extended hospitalization for treatment and to monitor and manage
multiple symptoms, life-threatening complications, and other adverse events which often
necessitate intensive care unit admissions. Given the significance of this illness and its
complications, adults with AL are commonly encouraged to rest during induction treatment.
Unfortunately, the long periods of hospitalization and rest result in diminished physical
function during and after treatment. In fact, patients are unable to function at pre-cancer
levels which can delay or prevent future intensive treatments, such as hematopoietic stem
cell transplant, that are most likely to be life-saving. Currently there are no clinical
interventions specific to assisting adults recovering from intense induction treatment.
However, PA programs have been shown to improve physical function and reduce symptoms in many
other clinical/disease contexts. Specifically, the Otago home-based program, has undergone
extensive testing internationally and has demonstrated effectiveness for improving strength,
mobility, balance and preventing falls in vulnerable older adults. Efforts to assess the
clinical efficacy of evidence-based PA programs for adults recovering from induction
treatment for AL are critically needed.
Conceptual/Theoretical Framework: The evaluation approach for this study is guided by the
RE-AIM (reach, efficacy, adoption, implementation, maintenance) evaluation framework. The
tailored PA intervention is guided by the information-motivation-behavioral (IMB) change
theory.
Main Research Variable(s): Reach: percent of eligible patients enrolled; Efficacy: physical
function assessments; Adoption: qualitative interviews to understand what is needed to adopt
the intervention into practice; Implementation: intervention fidelity/adherence; Maintenance:
qualitative interviews to understand what is needed to sustain the intervention in practice.
Design: This is a two-group randomized controlled trial (RCT) with an implementation-related
process evaluation of the tailored PA intervention. Participants will be randomized to either
the nurse-led PA intervention or the attention-control group.
Setting: NCI designated Comprehensive Cancer Center Sample: Adults diagnosed with AL
receiving consolidation/maintenance chemotherapy Methods: A longitudinal RCT over 3-months to
evaluate the efficacy of our nurse-led tailored home-based PA program versus
attention-control. Participants will complete physical function tests and questionnaires at
baseline, 6-weeks and 3-months. Both quantitative and qualitative data will be collected for
summative and formative data relevant to the reach, adoption, implementation, and maintenance
domains of RE-AIM.
Implications for Practice: Adults with AL experience decreased physical function and
concurrent symptoms that negatively affects quality of life (QOL) and may increase their risk
for further adverse events. This intervention would provide oncology nurses with tools to
support patients to engage in behaviors that improve their QOL.
