Effects of Qigong on Fatigue & Quality of Life in Elderly Prostate Cancer Survivors
55 Years
N/A
Both
Cancer Related Fatigue
Trial Information
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
significant others.
Recruitment occurs through Huntsman Cancer Institute's outpatient clinic and University and
community-based strategies (for example, newspaper ads, flyers, support groups, patient
registries).
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.
Inclusion Criteria:
- Significant fatigue as assessed during screening with the NCI Common Terminology
Criteria for Adverse Events (CTCAE) Safety Profiler of fatigue using a cut-off value
of ≥ 1; and/or with a fatigue grading scale (general questions that assess level of
fatigue currently and in the past week from a scale of 0-100) with a cut off value of
>20
- Are sedentary as defined by <150 minutes of mild, moderate, or intense intensity
exercise/week per Centers for Disease Control and Prevention(CDC) guidelines
- Able to speak and read English fluently, and understand informed consent
- Reside within 60 miles of Huntsman Cancer Institute and have access to regular
transportation to all assessments and intervention classes at HCI
- Willing to: sign a medical record release form; be randomized and willing to
participate in classes and all baseline and follow-up appointments
- Significant others and domestic partners of elderly prostate cancer survivors will be
eligible if they are at least 18 years of age, read and speak English, willing to
sign an informed consent, and provide a physician's release for exercise
Exclusion Criteria:
- Clinical evidence of metastatic disease other than elevated prostate-antigen specific
(PSA) levels
- Current practice of Qigong, Tai Chi or other similar types of Complementary and
Alternative medicine that may share similar principles of Qigong
- Inability to pass the Folstein Mini Mental Status Exam (score <23)
- Unable to drive or secure transportation to complete all aspects of the study
- Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or
neurological problems) that might interfere with the required intervention
- Unwilling to be randomized to study groups and/or commit to 12 weeks of Qigong or
non-aerobic stretching classes
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
Change in fatigue to 13 weeks
Outcome Description:
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).
Outcome Time Frame:
baseline to 13 weeks
Safety Issue:
No
Principal Investigator
Anita Kinney, RN, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Huntsman Cancer Institute, University of Utah
Authority:
United States: Institutional Review Board
Study ID:
U of Utah COA Pilot Grant
NCT ID:
NCT01564394
Start Date:
October 2011
Completion Date:
September 2012
Related Keywords:
- Cancer Related Fatigue
- qigong
- mindfulness meditation
- fatigue
- prostate cancer
- Fatigue
Name | Location |
|---|---|
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| University of Utah | Salt Lake City, Utah |
