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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: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Cancer Related Fatigue
Behavioral: Qigong
Behavioral: Non-aerobic stretching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Effects of Qigong on Fatigue & Quality of Life in Elderly Prostate Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change in fatigue to 13 weeks [ Time Frame: baseline to 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).


Secondary Outcome Measures:
  • Biometrics change to 13 weeks [ Time Frame: baseline to 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

  • Quality of Life change to 13 weeks [ Time Frame: baseline to 13 weeks ] [ Designated as safety issue: No ]
    Measures used to assess QOL include Brief Symptom Inventory-18 (BSI-18) & Medical Outcomes Study (MOS) SF-36, version 2.

  • Treatment-related symptoms change to 13 weeks [ Time Frame: baseline to 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


Enrollment: 62
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564394

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Anita Kinney, RN, PhD Huntsman Cancer Institute, University of Utah
  More Information

No publications provided

Responsible Party: Anita Kinney, Jon & Karen Huntsman Presidential Professor in Cancer Research, University of Utah
ClinicalTrials.gov Identifier: NCT01564394     History of Changes
Other Study ID Numbers: U of Utah COA Pilot Grant
Study First Received: March 22, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
qigong
mindfulness meditation
fatigue
prostate cancer

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014