Clinical trial NCT01564394: Body Mind Training Project
Official title: Effects of Qigong on Fatigue & Quality of Life in Elderly Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Related Fatigue
Keywords: qigong
mindfulness meditation
fatigue
prostate cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim 1: Assess the feasibility, safety and efficacy of a Qigong intervention in elderly prostate cancer survivors.

Describe participation, retention, and adherence rates and assess reasons for participation, attrition, and non-adherence.

Identify effective recruitment and retention strategies. Ascertain participants' level of satisfaction and additional perceptions of the experimental and control interventions, perceived study burden, study design, and implementation.

Aim 2: Provide preliminary data on potential effects of Qigong vs. non-aerobic stretching exercises on fatigue, psychosocial outcomes, and health-related quality of life in preparation for a future R01 application for a larger, definitive randomized controlled trial. Hypothesis: Qigong participants will have improved fatigue levels, quality of life, and related psychosocial and health outcomes compared to those randomized to the non-aerobic stretching group.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention Rate in Study (Feasibility Outcome)
timeFrame: 13-weeks
measure: Attendance Rates in Study (Feasibility Outcome)
timeFrame: 13-weeks
measure: FACIT-Fatigue Change From Baseline to 13-weeks.
timeFrame: Baseline to 13-weeks
Secondary outcomes:
measure: Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
timeFrame: Baseline to 13-weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Anita Kinney, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: