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Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy


N/A
60 Years
N/A
Open (Enrolling)
Both
Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult 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), Recurrent Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

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Trial Information

Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy


PRIMARY OBJECTIVES:

I. To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral
intervention designed to improve physical function in older adults receiving chemotherapy
for AML.

II. To estimate the effect size of the physical activity intervention on change in an
objective measure of physical function, SPPB (short physical performance battery).

SECONDARY OBJECTIVES:

I. To estimate the effects of the physical activity intervention on self-reported physical
function, health-related quality of life, and symptoms (depression, distress, fatigue).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients participate in an orientation session introducing the exercise program and
protocol, reviewing fundamental principles, and demonstrating each activity. Patients also
receive educational materials to facilitate orientation and adherence. Patients are offered
20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days
a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes
once weekly.

ARM II: Patients undergo usual care for 4 weeks.

After completion of study treatment, patients are followed up every two weeks for two months
and then monthly until week 24.


Inclusion Criteria:



- Diagnosis of AML with pathologic confirmation by World Health Organization (WHO)
criteria

- Planned induction chemotherapy

- Absence of active medical problems that preclude participation in exercise
(including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic
instability, uncontrolled pain)

- Patient must be ambulatory or able to walk with a cane

- Patients must have limited cognitive deficits (< 3 incorrect responses on the
Pfeiffer Mental Status Scale)

- Adequate English skills to understand and complete questionnaires

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Presence of active medical conditions precluding participation to exercise (e.g.,
ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)

- Inability to ambulate

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Feasibility, in terms of participation rates and barriers to recruitment and retention

Outcome Description:

Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.

Outcome Time Frame:

Approximately 4 weeks

Safety Issue:

No

Principal Investigator

Heidi Klepin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 97711

NCT ID:

NCT01519596

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult 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)
  • Recurrent Adult Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Wake Forest University Health Sciences Winston-Salem, North Carolina  27157