Congratulations to Tara Albrecht, assistant professor, and her entire team who have received an award for their Oncology Nursing Foundation proposal entitled: “Testing a Nurse-Led Evidence-Based Exercise Program to Improve Patient-Reported Outcomes in Adults with Acute Leukemia.” This award is for a two-year period with a start date of September 2020.

Purpose/Specific Aim

The purpose of this study is to test the efficacy of an evidence-based tailored physical activity (PA) program adapted for adults with acute leukemia (AL). The team will also conduct an implementation-related process evaluation of the PA intervention.

Rationale/Significance of Study

ALs 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, such as Otago, that is adapted 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

The team proposes 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

The team proposes 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, six weeks and three months. The team will use mixed methods to collect 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.