NCT02584296

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable leukemia

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

September 28, 2015

Last Update Submit

January 5, 2017

Conditions

LeukemiaMyeloidMonocytic

Outcome Measures

Primary Outcomes (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.

    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

Study Arms (2)

Usual care control

NO INTERVENTION

Phase 1 will be observation only, and will be considered a usual care control group, activity at home.

Biobehavioral self management approach

EXPERIMENTAL

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

Interventions

BSMABEHAVIORAL

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.

Also known as: Biobehavioral self management approach
Biobehavioral self management approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • currently experiencing psychiatric or neurologic disorders that would prevent their ability to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Tara Albrecht, PhD, ACNP-BC

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 22, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

US(1)