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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT02584296
Collaborator
Massey Cancer Center (Other)
23
Enrollment
1
Location
2
Arms
20.1
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BSMA
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid Leukemia
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual care control

Phase 1 will be observation only, and will be considered a usual care control group, activity at home.
Experimental: Biobehavioral self management approach

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
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.
Other Names:
  • Biobehavioral self management approach

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University
    • Massey Cancer Center

    Investigators

    • Principal Investigator: Tara Albrecht, PhD, ACNP-BC, Virginia Commonwealth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT02584296
    Other Study ID Numbers:
    • MCC-15-11061
    • HM20004012
    First Posted:
    Oct 22, 2015
    Last Update Posted:
    Jan 6, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Leukemia

    Study Results

    No Results Posted as of Jan 6, 2017