Study Procedure:
Subjects will be stratified by cancer diagnosis and
type of cancer treatment, and then randomized to exercise (EX) or usual care
(UC) groups. Subjects in the EX group will be prescribed an
individualized home based walking exercise program that the patients will
maintain throughout their cancer treatment. Subjects in the control
group will receive the usual care given during cancer treatment (no
prescribed walking program). In addition, both groups will receive a
patient education booklet, Managing Fatigue.
All subjects will be assessed by treadmill and
symptom questionnaires at pretest (baseline before cancer treatment) and
at posttest (end of radiotherapy or chemotherapy). In addition,
fatigue and other symptoms will be assessed at mid-treatment for both
groups. Follow-up symptom assessments will be conducted at one month,
three months, and six months posttreatment.
The major outcome variable is
fatigue level; additional variables are physical functioning (VO2 max, walking ability,
muscle fitness tests), emotional distress, difficulty sleeping, and
health
related quality of life. Groups will be compared by repeated measures
ANOVA or ANCOVA. Multivariate regression procedures will be used to
determine the predictors of cancer-related fatigue and of adherence to
exercise during cancer treatment.
This study is significant because it tests the
efficacy and effectiveness of a low-cost self-care health promotion activity
in mitigating fatigue, the most common and distressing symptom of cancer
treatment. The biobehavioral outcomes include both subjective
self-reported symptoms and objective physiologic changes in physical
capacity and performance.
