NCT00554489

Brief Summary

RATIONALE: Physical activity sessions may help improve physical function, quality of life, and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia. PURPOSE: This clinical trial is studying how well physical activity works in improving quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable leukemia

Timeline
Completed

Started Jul 2007

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

November 6, 2007

Last Update Submit

August 14, 2017

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)

Outcome Measures

Primary Outcomes (5)

  • Percentage of adults 50 years of age or older admitted for induction or reinduction chemotherapy for acute myeloid leukemia (AML) who are eligible for the study

    day 1

  • Percentage of eligible patients recruited into the study

    day 1

  • Number and frequency of reported barriers to eligibility and enrollment

    day 1

  • Percentage of study participants who successfully completed the physical and the psychosocial measures

    week 13

  • Record barriers to completion of the physical activity program

    week 13

Secondary Outcomes (2)

  • Physical function as measured by the Short Physical Performance Battery (SPPB)

    week 13

  • Quality of Life as measured with the Distress Thermometer

    week 13

Interventions

exercise interventionBEHAVIORAL

participation in physical activity intervention program weeks 2 through 5

Eligibility Criteria

Age50 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (AML) by WHO criteria * Planning to undergo induction or reinduction chemotherapy * Inpatient status at Wake Forest University Baptist Medical Center * Must not require intensive care unit support PATIENT CHARACTERISTICS: * Able to understand English * Medical eligibility confirmed with Leukemia Service Attending * Ambulatory or able to walk with a cane * No hemodynamic instability * No acute thrombosis within the past 7 days * No active ischemia within the past 7 days * No uncontrolled pain * Must have \< 3 incorrect responses on the Pfeiffer Mental Status Exam PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteCongenital Abnormalities

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Suzanne C. Danhauer, PhD

    Wake Forest University Health Sciences

    STUDY CHAIR

  • Heidi D. Klepin, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Shannon Mihalko, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 7, 2007

Study Start

July 1, 2007

Primary Completion

November 1, 2008

Study Completion

April 1, 2011

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations

US(1)