Alibhai, S.M., O'Neill, S., Fisher-Schlombs, K., Breunis, H., Timilshina, N., Brandwein, J.M., . . . Culos-Reed, S.N. (2014). A pilot phase II RCT of a home-based exercise intervention for survivors of AML. Supportive Care in Cancer, 22, 881–889. 

DOI Link

Study Purpose

To examine the feasibility (recruitment, retention, and adherence), preliminary efficacy, and safety of a 12-week, home-based exercise program for middle-aged and older acute myeloid leukemia (AML) survivors

Intervention Characteristics/Basic Study Process

Subjects were randomized to the active intervention received an individualized exercise program designed by a certified exercise physiologist. Participants were asked to exercise three to five days per week at a moderate intensity at home. The duration of exercise was increased over the course of the intervention with a target of 30 minutes per session (150 minutes per week). In an effort to enhance social support and utilize the group dynamics known to promote physical activity participation (10), participants were invited to attend once-weekly group-based booster sessions for the duration of the 12-week intervention. Control group participants were instructed to maintain their usual level of physical activity. Every three weeks, there was no other contact with the control group. At the end of 12 weeks, participants assigned to the control group were allowed to cross over to the exercise intervention and were offered the same exercise program as the intervention group. 

Sample Characteristics

  • N = 40  
  • AVERAGE AGE = 56 years
  • MALES: 45%, FEMALES: 55%
  • KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia; the average time from diagnosis to study enrollment for all participants was approximately two years.
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants were mostly white. The mean body mass index (BMI) 28.25%. Patients had undergone posthematopoietic stem cell transplant.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: Home and “health care” gym

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment
  • APPLICATIONS: Elder care  

Study Design

Phase II randomized controlled trial with an exercise group and a wait-list control group that could cross over to the exercise group at week 12.

Measurement Instruments/Methods

  • Primary outcome measures included both global quality of life (QOL) and fatigue.
  • QOL was measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).  
  • Functional Assessment of Cancer Therapy–Fatigue (FACT-F)
  • Secondary outcome measures included the Edmonton Symptom Assessment Scale (ESAS).

Results

Recruitment and retention rates were 31% and 91%, respectively. The adherence rate was 28%. The analyses did not suggest statistically significant or clinically important benefits in QOL, fatigue, or physical fitness between groups. There were no adverse events.

Conclusions

Successful recruitment with low adherence and limited effects on clinical outcomes including fatigue.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • Other limitations/explanation: The description of the cross-over of patients from the control group is confusing and inconsistently described from the actual protocol.

Nursing Implications

Further study is needed in this population including how to enhance exercise adherence.