Effects of Qigong on Fatigue & Quality of Life in Elderly Prostate Cancer Survivors
This ongoing feasibility study is a two-armed, parallel group, randomized clinical
trial.We will recruit 60 elderly prostate cancer survivors (age 55+ years) and their
significant others (spouse, domestic partner, or close family member).
Considering literature attesting to strains associated with caregiver status, we will also
collect survey and physical assessment data to explore the intervention's effect on
Recruitment occurs through Huntsman Cancer Institute's outpatient clinic and University and
community-based strategies (for example, newspaper ads, flyers, support groups, patient
We will measure relevant psychosocial measures, including fatigue and quality of life (SF36
& EPIC), perceived stress, distress, mood, cognitive function, social connectedness,
demographics, and leisure time, at baseline, the six-week midpoint, and one week
post-intervention. Weekly measures of fatigue and quality of life and physical activity logs
will also be administered.
Biometric assessments, including balance and mobility, flexibility, blood pressure, resting
heart rate, body mass index, and waist-hip-ratio, will be done at baseline (before
randomization) and one week post-intervention.
Significant others will undergo the same survey measures as the prostate cancer survivors,
except for measures specific to prostate cancer (e.g., EPIC-26-short form).
Participants will be recruited in two cohorts, one beginning early March and the other early
June, 2012. The twice-weekly exercise classes will be 60 minutes in duration, running for
12 weeks. Classes will be conducted at Huntsman Cancer Institute's Survivor & Wellness
Center, beginning one week after baseline physical assessments. Participants will receive a
DVD of the respective class led by trained and qualified instructors so they can supplement
classes with home-based sessions.
Qigong class will consist of postures, movements, deep breathing techniques, and meditation,
including an emphasis on weight shifting, breath, and posture control.
Non-aerobic stretching will consist of light stretching exercises that avoid focus on
meditation. This class will serve as the control group for non-specific factors such as
attention dose and the group setting.
To ensure consistency of physical intensity between the two study arms, both objective
(heart rate monitors) and subjective (self-reported ten-point Borg scale) measures will be
performed on participants.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Change in fatigue to 13 weeks
Our primary outcome of change in fatigue will be assessed with the FACIT-fatigue, the CTCAE Safety Profiler of fatigue, and a fatigue grading scale (general questions that assess level of fatigue currently and in the past week).
baseline to 13 weeks
Anita Kinney, RN, PhD
Huntsman Cancer Institute, University of Utah
United States: Institutional Review Board
U of Utah COA Pilot Grant
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|University of Utah||Salt Lake City, Utah|