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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584296
• Other study ID #: MCC-15-11061
• Secondary ID: HM20004012
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: January 5, 2017
• Start date: March 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Leukemia
• Monocytic
• Myeloid

Intervention

Behavioral:
• BSMA
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Massey Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No