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

January 5, 2017 updated by: Virginia Commonwealth University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.
Time Frame: 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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Massey Cancer Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (ESTIMATE)

October 22, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-15-11061
  • HM20004012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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