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

Not Applicable

Completed

• Conditions: Leukemia; Myeloid; Monocytic
• Interventions: Behavioral: BSMA

• Registration Number: NCT02584296
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biobehavioral self management approach	BSMA	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.

Primary Outcome Measures

Name	Time	Method
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.	3 months	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).

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States