Physical Activity as Self-Management Approach to Improve Health Outcomes in AML

Study Overview
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Brief Summary
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Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid Leukemia

Detailed Description
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Guided by the information-motivation-behavioral skills model and using a quasi-experimental cohort control research design, the primary aim of this study is to: Determine the feasibility of the biobehavioral self management approach (BSMA) program involving physical activity (PA) in patients receiving consolidation treatment for AML. The primary feasibility outcomes for this aim will be rates of recruitment, refusal, retention and attrition; in addition investigators will test methods and procedures of the prescribed BSMA PA program, including assessing adherence, participant acceptance and perceived benefit.

Official Title
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Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid Leukemia

Conditions
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Leukemia, Myeloid, Monocytic

Intervention / Treatment
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* Behavioral: BSMA


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: ≥18 years diagnosis of AML hospitalized for consolidation chemotherapy within 1 day (+/- 2 days) read and write in English able to stand independently not experiencing psychiatric neurological disorders (assessed through clinical team members) that would prevent obtaining consent. Exclusion criteria: currently experiencing psychiatric or neurologic disorders that would prevent their ability to provide consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care control<br>Phase 1 will be observation only, and will be considered a usual care control group, activity at home. | |
| Experimental: Biobehavioral self management approach<br>Phase 2 participants will receive the Biobehavioral self management approach (BSMA) intervention aligned with the IMB model; introduced over three days of each five-day consolidation chemotherapy hospital admission. | Behavioral: BSMA<br>* Biobehavioral self-management approach (BSMA) intervention is aligned with information-motivation-behavioral skills (IMB) model and is guided physical activity (PA). Collects demographic, medical, disease, treatment data, blood specimens and the battery of measures. Includes PA self-assessment, 6 minute walk test(6MWT) and chair squat test (CST) with Physical Therapist (PT); provides PA handouts based on American Cancer Society (ACS) guidelines, discusses known benefits, beliefs and goals of PA (IMB health behavior motivation); assess/discuss perceived barriers to PA. PT or Exercise physiologist (EP) works with subject on various exercises (both strength and aerobic,  30 minutes; IMB behavioral skills);PT or EP reviews exercises, subject practices, and provides a BSMA program (including strength/aerobic training) for subject to begin upon discharge. Subject keeps journal of PA and wears accelerometer (TAA) to record PA levels. 3-weeks at home study nurse calls subjects each week.<br>* Other names: Biobehavioral self management approach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of recruitment, refusal, retention, and attrition will be aggregated to determine the feasibility of the BSMA program for patients receiving consolidation treatment for AML. | These aggregated rates will help determine the feasibility of the biobehavioral self-management approach (BSMA) program involving physical activity (PA) in patients receiving consolidation treatment for acute myeloid leukemia (AML). The primary aim of this study rates of recruitment, refusal, retention, and attrition in the BSMA program for patients receiving consolidation treatment for AML will be reported rates of recruitment (number enrolled, refused), retention, and adherence (trends in exercise capacity as measured by 6minute walk test, strength test and chair to stand test; completed physical activity log; and accelerometer data). | 3 months |