N/A
Completed N=60
Body Mind Training Project
Source: ClinicalTrials.gov NCT01564394 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Retention Rate in Study (Feasibility Outcome) — 0.80; 0.65 proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Rate in Study (Feasibility Outcome) |
0.80; 0.65 | — |
| PRIMARY Attendance Rates in Study (Feasibility Outcome) |
0.85; 0.68 | — |
| PRIMARY FACIT-Fatigue Change From Baseline to 13-weeks. |
5.0; 0.0; 2.5; 0.0 | — |
| SECONDARY Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks |
-7.0; 0.0; -7.5; 0.0; -6.5; 0.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01564394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.