An interventional study of Qigong and Non-aerobic stretching in Cancer Related Fatigue, sponsored by University of Utah. Completed at 2 sites in United States. Open to participants aged 55 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-12-08.
Sponsored by University of Utah · Not applicable, Interventional, and Supportive care
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.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 60 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
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
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
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.
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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline to 13-weeks
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
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.
Time frame: Baseline to 13-weeks
We recruited 502 senior prostate cancer survivors in Utah through clinic referrals, registries, community advertisements, and community-based support groups.
| Milestone | Qigong | Stretching Control |
|---|---|---|
| Started | 30 | 30 |
| Completed | 24 | 20 |
| Not completed | 6 | 10 |
| Withdrew: Withdrawal by subject | 6 | 10 |
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.
| T-Score | Qigong | Stretching Control |
|---|---|---|
| Prostate Cancer Survivors Global Index Change | -7.0 (-12.0 to -3.2) | 0.0 (-4.0 to 1.5) |
| Prostate Cancer Survivors Anxiety Change | -7.5 (-8.0 to 0.0) | 0.0 (0.0 to 7.5) |
| Prostate Cancer Survivors Somatization Change | -6.5 (-10.7 to -0.2) | 0.0 (-4.0 to 2.0) |
| Prostate Cancer Survivors Depression Change | -6.5 (-12.0 to 0.0) | 0.0 (-6.5 to 0.5) |
| Family Member Global Index Change | -3.5 (-7.7 to 0.0) | -2.0 (-13.0 to 3.0) |
| Family Member Anxiety Change | -1.0 (-3.7 to 0.0) | -7.0 (-8.0 to 0.0) |
| Family Member Somatization Change | 0.0 (-6.7 to 0.0) | 0.0 (-6.0 to 7.0) |
| Family Member Depression Change | -5.0 (-6.7 to 0.0) | -3.0 (-10.0 to 0.0) |
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).
| proportion of participants | Qigong | Stretching Control |
|---|---|---|
| Retention Rate in Study (Feasibility Outcome) | 0.80 | 0.65 |
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).
| Proportion of classes | Qigong | Stretching Control |
|---|---|---|
| Attendance Rates in Study (Feasibility Outcome) | 0.85 | 0.68 |
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.
| Units on scale | Qigong | Stretching Control |
|---|---|---|
| Prostate Cancer Survivor FACIT-Fatigue Change | 5.0 (2.0 to 12.7) | 0.0 (-5.5 to 4.5) |
| Family Member FACIT-Fatigue Change | 2.5 (-0.7 to 6.0) | 0.0 (-2.0 to 5.0) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Qigong | — | 0/30 (0%) | 0/30 (0%) |
| Stretching Control | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Qigong | Stretching Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 9 | 16 |
| >=65 years | 23 | 21 | 44 |
| Age, Continuous(years) | Qigong | Stretching Control | Total |
|---|---|---|---|
| Mean | 71.3 ± 9.6 | 71.2 ± 10.1 | 71.2 ± 9.7 |
| Sex: Female, Male(Participants) | Qigong | Stretching Control | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 20 | 21 | 41 |
| Region of Enrollment(participants) | Qigong | Stretching Control | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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