Trial Outcomes & Findings for Body Mind Training Project (NCT NCT01564394)
NCT ID: NCT01564394
Last Updated: 2015-12-08
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
13-weeks
Results posted on
2015-12-08
Participant Flow
We recruited 502 senior prostate cancer survivors in Utah through clinic referrals, registries, community advertisements, and community-based support groups.
Out of 89 prostate cancer survivors screened for eligibility, forty were eligible and interested in participating in the study.Twenty family members met criteria for participating. Only the survivors were randomized to study arms. Family members attended the study arm that the survivor was randomized to.
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
10
|
Baseline Characteristics
Body Mind Training Project
Baseline characteristics by cohort
| Measure |
Qigong
n=30 Participants
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.
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.
|
Stretching Control
n=30 Participants
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.
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
71.2 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
71.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13-weeksThe 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).
Outcome measures
| Measure |
Qigong
n=20 Participants
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.
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.
|
Stretching Control
n=20 Participants
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.
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.
|
|---|---|---|
|
Retention Rate in Study (Feasibility Outcome)
|
0.80 proportion of participants
|
0.65 proportion of participants
|
PRIMARY outcome
Timeframe: 13-weeksThe 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).
Outcome measures
| Measure |
Qigong
n=20 Participants
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.
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.
|
Stretching Control
n=20 Participants
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.
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.
|
|---|---|---|
|
Attendance Rates in Study (Feasibility Outcome)
|
0.85 Proportion of classes
|
0.68 Proportion of classes
|
PRIMARY outcome
Timeframe: Baseline to 13-weeksPopulation: Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .
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.
Outcome measures
| Measure |
Qigong
n=24 Participants
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.
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.
|
Stretching Control
n=20 Participants
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.
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.
|
|---|---|---|
|
FACIT-Fatigue Change From Baseline to 13-weeks.
Prostate Cancer Survivor FACIT-Fatigue Change
|
5.0 Units on scale
Interval 2.0 to 12.7
|
0.0 Units on scale
Interval -5.5 to 4.5
|
|
FACIT-Fatigue Change From Baseline to 13-weeks.
Family Member FACIT-Fatigue Change
|
2.5 Units on scale
Interval -0.7 to 6.0
|
0.0 Units on scale
Interval -2.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline to 13-weeksPopulation: Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .
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.
Outcome measures
| Measure |
Qigong
n=24 Participants
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.
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.
|
Stretching Control
n=20 Participants
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.
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.
|
|---|---|---|
|
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
Prostate Cancer Survivors Global Index Change
|
-7.0 T-Score
Interval -12.0 to -3.2
|
0.0 T-Score
Interval -4.0 to 1.5
|
|
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
Prostate Cancer Survivors Anxiety Change
|
-7.5 T-Score
Interval -8.0 to 0.0
|
0.0 T-Score
Interval 0.0 to 7.5
|
|
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
Prostate Cancer Survivors Somatization Change
|
-6.5 T-Score
Interval -10.7 to -0.2
|
0.0 T-Score
Interval -4.0 to 2.0
|
|
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
Prostate Cancer Survivors Depression Change
|
-6.5 T-Score
Interval -12.0 to 0.0
|
0.0 T-Score
Interval -6.5 to 0.5
|
|
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
Family Member Global Index Change
|
-3.5 T-Score
Interval -7.7 to 0.0
|
-2.0 T-Score
Interval -13.0 to 3.0
|
|
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
Family Member Anxiety Change
|
-1.0 T-Score
Interval -3.7 to 0.0
|
-7.0 T-Score
Interval -8.0 to 0.0
|
|
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
Family Member Somatization Change
|
0.0 T-Score
Interval -6.7 to 0.0
|
0.0 T-Score
Interval -6.0 to 7.0
|
|
Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks
Family Member Depression Change
|
-5.0 T-Score
Interval -6.7 to 0.0
|
-3.0 T-Score
Interval -10.0 to 0.0
|
Adverse Events
Qigong
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stretching Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anita Y. Kinney, PhD
Huntsman Cancer Institute, University of Utah
Phone: 801-585-1151
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place