Body Mind Training Project
Condition: Cancer Related Fatigue
MeSH terms: Fatigue
Study type: Interventional

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.
    

Intervention name(s): Qigong; Non-aerobic stretching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: qigong; mindfulness meditation; fatigue; prostate cancer