Body Mind Training Project

NCT01564394 | Completed Results DMC

• 1 other identifier: U of Utah COA Pilot Grant
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer Related Fatigue

Keywords

qigong; mindfulness meditation; fatigue; prostate cancer

Outcome Measures

Primary Outcomes (3)

• Retention Rate in Study (Feasibility Outcome)

  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).

  13-weeks

• Attendance Rates in Study (Feasibility Outcome)

  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).

  13-weeks

• FACIT-Fatigue Change From Baseline to 13-weeks.

  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.

  Baseline to 13-weeks

Secondary Outcomes (1)

• Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks

  Baseline to 13-weeks

Study Arms (2)

Qigong

EXPERIMENTAL

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

Stretching control

SHAM COMPARATOR

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

Interventions

Qigong BEHAVIORAL

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.

Qigong

Non-aerobic stretching BEHAVIORAL

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.

Stretching control

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Fatigue; Prostatic Neoplasms

Interventions

Qigong

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Anita Y. Kinney, PhD
• Organization: Huntsman Cancer Institute, University of Utah

anita.kinney@hci.utah.edu

801-585-1151

Study Officials

• Anita Kinney, RN, PhD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jon & Karen Huntsman Presidential Professor in Cancer Research

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 27, 2012
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 8, 2015
• Results First Posted: August 19, 2015

Record last verified: 2015-11

Locations

US (2)