A Study of a Home-based Exercise Intervention for Patients With Acute Myeloid Leukaemia (AML)
Condition: Acute Myeloid Leukemia; Exercise; Fatigue; Quality of Life
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      Fatigue is the most common and disabling symptom in acute myeloid leukaemia (AML). Studies in
      other cancer patients with fatigue have shown that exercise improves both fatigue and quality
      of life (QOL), but there are no such studies in AML. The investigators want to conduct a
      pilot study of a home-based exercise program to see if this type of exercise program is
      feasible for AML patients, reduces fatigue, and improves QOL. What the investigators learn
      from this study will be essential to designing a larger, definitive randomized trial of
      exercise in patients with AML.
    

Detailed description: 
      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.
    

Intervention name(s): Home-based exercise program; Wait list
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will be given a personalized 12-week exercise program consisting of cardiovascular, musculoskeletal and flexibility exercises by a certified exercise physiologist. They will receive fitness assessments at baseline, 6 weeks and 12 weeks.; Subjects will have a 12-week waiting period, during which time they will be asked not to change their exercise habits. These subjects will receive the same fitness assessments as the experimental group (baseline, 6 weeks, 12 weeks), but will not receive an exercise program during the wait-list period. Following the 12-week wait-list period, subjects will be given the same home-based exercise intervention as the experimental group.
Other intervention name(s): exercise; fitness; exercise; fitness
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myeloid leukemia; exercise; fatigue; quality of life; home-based; AML