Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Body Mind Training Project

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anita Kinney, University of Utah
ClinicalTrials.gov Identifier:
NCT01564394
First received: March 22, 2012
Last updated: November 9, 2015
Last verified: November 2015

March 22, 2012
November 9, 2015
October 2011
September 2012   (final data collection date for primary outcome measure)
  • Retention Rate in Study (Feasibility Outcome) [ Time Frame: 13-weeks ] [ Designated as safety issue: No ]
    The retention rate was the proportion of participants who remained enrolled in the study and completed post-intervention measures. Range of retention rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).
  • Attendance Rates in Study (Feasibility Outcome) [ Time Frame: 13-weeks ] [ Designated as safety issue: No ]
    The class attendance rates were the number of classes attended by participants divided by the total number of classes offered. Range of attendance rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).
  • FACIT-Fatigue Change From Baseline to 13-weeks. [ Time Frame: Baseline to 13-weeks ] [ Designated as safety issue: No ]
    Our primary outcome of change in fatigue was assessed with the Functional Assessment Chronic Illness Therapy (FACIT)-Fatigue scale. This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.
Change in fatigue [ Time Frame: baseline, weekly, 6 weeks, 13 weeks ] [ Designated as safety issue: No ]
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).
Complete list of historical versions of study NCT01564394 on ClinicalTrials.gov Archive Site
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks [ Time Frame: Baseline to 13-weeks ] [ Designated as safety issue: No ]
The BSI-18 assesses global distress and three subscales (anxiety, depression, & somatization). Scores are converted to T-scores based on US population norms. Negative change scores indicate improvement in distress. We report data separately for prostate cancer survivors and family members. Based on the population norm a T-score of 63 or above indicates heightened global distress.
  • Quality of Life [ Time Frame: baseline, 6 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Measures used to assess QOL include Brief Symptom Inventory-18 (BSI-18), Perceived Stress Scale, Interpersonal Support Evaluation List-16-item, Medical Outcomes Study (MOS) SF-36, version 2 with the acute 'past week' recall PANAS, and Purpose in Life Subscale.
  • Physical health outcomes of physical activity [ Time Frame: baseline, weekly, 6 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Measured with the Godin Leisure Time Scale/Index and a weekly physical activity log
  • Treatment-related symptoms [ Time Frame: baseline, 6 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Expanded Prostate Cancer Index Composite (EPIC-26-short form)will be administered to the prostate cancer survivors only
  • Biometrics [ Time Frame: baseline, 13 weeks ] [ Designated as safety issue: Yes ]
    Biometric testing includes balance/mobility, flexibility (back scratch), blood pressure, resting heart rate (RHR), BMI, and waist-hip-ratio measurements
  • Cognitive Function [ Time Frame: baseline, 6 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Measured by the Medical Outcomes Study Cognitive Function Scale -6items
  • Social Connectedness [ Time Frame: baseline, 6 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Measured by a 4-item scale
Not Provided
Not Provided
 
Body Mind Training Project
Effects of Qigong on Fatigue & Quality of Life in Elderly Prostate Cancer Survivors

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Cancer Related Fatigue
  • Behavioral: Qigong
    Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors.
  • Behavioral: Non-aerobic stretching
    The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation.
  • Experimental: Qigong
    Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.
    Intervention: Behavioral: Qigong
  • Sham Comparator: Stretching control
    The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.
    Intervention: Behavioral: Non-aerobic stretching
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
55 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01564394
U of Utah COA Pilot Grant
Yes
Not Provided
Not Provided
Anita Kinney, University of Utah
University of Utah
Not Provided
Principal Investigator: Anita Kinney, RN, PhD Huntsman Cancer Institute/ University of Utah
University of Utah
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP