Trial Information

A Pilot Study of a Home-based Exercise Intervention for Patients With AML

Background: Fatigue is the most common and disabling symptom affecting patients with acute
myeloid leukaemia (AML). Fatigue is negatively associated with quality of life (QOL) and
daily function, and remains a major problem for patients even 6 months after completion of
treatment (12 months after diagnosis). Despite this, there have been no intervention studies
to reduce fatigue and improve QOL in AML. In a number of studies done in mostly younger
patients with solid tumours, exercise has been shown to improve fatigue and QOL. Because of
important differences between older patients with AML and younger patients with solid
tumours, a randomized trial needs to be performed in this population. Prior to embarking on
a definitive study, a pilot study is needed to ensure feasibility, to estimate recruitment
rates, and to demonstrate if exercise is effective in reducing fatigue in older patients
with AML.

Objectives: (1) To determine the feasibility of recruitment to, and patient adherence with,
a 12-week home-based exercise intervention study among patients age 40 or older with AML in
complete remission. (2) To provide estimates of the effects of exercise on fatigue and QOL
to facilitate the design of a RCT. (3) To examine the relationship between exercise
adherence, improvements in fitness, fatigue, and QOL in AML patients undergoing a home-based
exercise intervention.

Methods: Patients age 40 or older with AML who have completed chemotherapy and achieved
complete remission are eligible for the study. Patients will be recruited at the Princess
Margaret Hospital, Canada's largest AML referral centre. Fitness and QOL measures will be
assessed at baseline, half-way through the intervention, at the end of the 12-week exercise
intervention, and 12 weeks later. Patients will be randomized to the intervention arm or a
wait-list control. The intervention consists of a structured, personalized, 12-week
home-based exercise program that is theory-based and modelled after a successful program in
patients with another malignancy. A certified fitness instructor will lead the intervention.
Patients in the wait-list control group will be asked to maintain usual level of activity
for 12 weeks, after which they will be crossed over to the intervention arm to receive an
identical intervention. Fitness measures include anthropometric measures, the 6-minute walk
test, grip strength, and a measure of flexibility. The primary outcome measure is fatigue,
which will be measured with the FACT Fatigue subscale. QOL will be assessed with the EORTC
QLQ-C30. Weekly telephone assessments and 5 in-clinic assessments over the duration of the
program will be done to measure program adherence. The investigators plan to approach 100
patients over a 12-month period and anticipate recruiting 40 patients. A detailed
recruitment log will be maintained. Mixed effects linear regression models will be used to
measure the effect of the intervention on fatigue and QOL. Relationships between changes in
fitness level will be regressed with changes in fatigue and QOL in a secondary analysis. The
impact of exercise adherence on outcomes will also be assessed.

Significance: Despite the importance of fatigue in patients with AML, its treatment remains
poorly understood.The investigators plan to evaluate the most promising intervention,
exercise, in a pilot study. The results of our study will be crucial to the design of a
definitive multi-centre randomized trial to lessen fatigue and improve overall QOL in
middle-aged and older patients with AML.