Clinical trial NCT04552912: Physical Activity to Improve Patient Reported Outcomes for Adults With Acute Leukemia
Official title: Testing a Nurse-Led Evidence-Based Exercise Program to Improve Patient-Reported Outcomes in Adults With Acute Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Exercise
Acute Leukemia
Consolidation
Maintenance Therapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Society
First posted: 2020-09-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* Diagnosed with either acute leukemia
* Receiving either maintenance or consolidation chemotherapy
* Able to walk independently for 4 meters with or without gait aid.

Exclusion Criteria:

* non-English speaking
* receiving induction chemotherapy.

Primary outcomes:
measure: Physical Function- Short Physical Performance Battery Protocol
timeFrame: 12-weeks
measure: Physical Function- 6 Minute walk test
timeFrame: 12-weeks
Secondary outcomes:
measure: Patient-Reported Outcomes- Cognition
timeFrame: 12-weeks
measure: Patient-Reported Outcomes-Fatigue
timeFrame: 12-weeks
measure: Patient-Reported Outcomes-Disturbed Sleep
timeFrame: 12-weeks
measure: Patient-Reported Outcomes-Anxiety
timeFrame: 12-weeks
measure: Patient-Reported Outcomes-Depression
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Tara A Albrecht, PhD, ACNP-BC, ACNP-BC, ACHPN
role: PRINCIPAL_INVESTIGATOR
References: