Trial Outcomes & Findings for Project HERO: Health Empowerment & Recovery Outcomes (NCT NCT03345563)
NCT ID: NCT03345563
Last Updated: 2026-07-07
Results Overview
13-item self-report scale assessing fatigue and its impact on daily activities during the past 7 days; higher scores indicate less fatigue (range 0-52).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention
Results posted on
2026-07-07
Participant Flow
Participants were recruited from the University of New Mexico Comprehensive Cancer Center and the Rutgers Cancer Institute of New Jersey, state cancer registry mailings, oncology clinics, and community outreach between July 2017 and October 2022. Eligibility was confirmed through telephone and in-person screening before randomization.
Following eligibility screening and consent, participants completed baseline assessments, including questionnaires and biospecimen collection, prior to randomization. A total of 113 participants were enrolled across sites.
Participant milestones
| Measure |
Usual Care (UC/Control)
Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.
|
Body Training (BT/Exercise Intensity-Matched Control)
Participants engaged in instructor-led stretching and controlled movements twice weekly for 12 weeks, matched to the physical intensity of BMT without the mindfulness components.
|
Body-Mind Training (BMT/Tai Chi Qigong)
Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
43
|
45
|
|
Overall Study
Completed 13-Week Intervention Assessment
|
20
|
33
|
39
|
|
Overall Study
COMPLETED
|
15
|
30
|
32
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
13
|
Reasons for withdrawal
| Measure |
Usual Care (UC/Control)
Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.
|
Body Training (BT/Exercise Intensity-Matched Control)
Participants engaged in instructor-led stretching and controlled movements twice weekly for 12 weeks, matched to the physical intensity of BMT without the mindfulness components.
|
Body-Mind Training (BMT/Tai Chi Qigong)
Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
8
|
Baseline Characteristics
Project HERO: Health Empowerment & Recovery Outcomes
Baseline characteristics by cohort
| Measure |
Usual Care (UC/Control)
n=25 Participants
Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.
|
Body Training (BT/Exercise Intensity-Matched Control)
n=43 Participants
Participants engaged in instructor-led stretching and controlled movements twice weekly for 12 weeks, matched to the physical intensity of BMT without the mindfulness components.
|
Body-Mind Training (BMT/Tai Chi Qigong)
n=45 Participants
Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
21 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
87 Participants
n=5 Participants
|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 6.9 • n=20 Participants
|
68.3 years
STANDARD_DEVIATION 7.2 • n=20 Participants
|
69.4 years
STANDARD_DEVIATION 7.0 • n=40 Participants
|
69.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
45 Participants
n=40 Participants
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=20 Participants
|
41 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
|
Body Mass Index
|
29.7 kg/m²
STANDARD_DEVIATION 4.8 • n=20 Participants
|
29.6 kg/m²
STANDARD_DEVIATION 5.4 • n=20 Participants
|
31.2 kg/m²
STANDARD_DEVIATION 8.1 • n=40 Participants
|
30.3 kg/m²
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Marital Status
Single/Divorced/Separated/Widowed
|
7 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
26 Participants
n=5 Participants
|
|
Marital Status
Married/Domestic Partnership
|
18 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
86 Participants
n=5 Participants
|
|
Marital Status
Missing
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Education Level
Less than high school/High school grad/GED
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
16 Participants
n=5 Participants
|
|
Education Level
Some college/Assoc. Degree/Vocational School
|
8 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
32 Participants
n=5 Participants
|
|
Education Level
Bachelor's degree or higher
|
16 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
64 Participants
n=5 Participants
|
|
Education Level
Missing
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Income
<$30,000
|
1 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
|
Income
$30,000-$49,999
|
1 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
|
Income
$50,000-$69,999
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
14 Participants
n=5 Participants
|
|
Income
$70,000 or more
|
14 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
58 Participants
n=5 Participants
|
|
Income
Missing
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
22 Participants
n=5 Participants
|
|
Health Insurance
No
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
|
Health Insurance
Yes
|
24 Participants
n=20 Participants
|
42 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
109 Participants
n=5 Participants
|
|
Health Insurance
Missing
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Diagnosis
Prostate only
|
21 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
36 Participants
n=40 Participants
|
87 Participants
n=5 Participants
|
|
Cancer Diagnosis
Prostate and other types of invasive cancer(s)
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
|
Cancer Diagnosis
Other cancer type(s)
|
0 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
15 Participants
n=5 Participants
|
|
Stage of Disease
Local
|
18 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
73 Participants
n=5 Participants
|
|
Stage of Disease
Regional
|
2 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
10 Participants
n=5 Participants
|
|
Stage of Disease
Distant/Biochemical Disease
|
5 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
30 Participants
n=5 Participants
|
|
Currently Taking Hormone Therapy
No
|
20 Participants
n=20 Participants
|
35 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
84 Participants
n=5 Participants
|
|
Currently Taking Hormone Therapy
Yes
|
5 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention13-item self-report scale assessing fatigue and its impact on daily activities during the past 7 days; higher scores indicate less fatigue (range 0-52).
Outcome measures
| Measure |
Usual Care (UC/Control)
n=25 Participants
Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.
|
Body Training (BT/Exercise Intensity-Matched Control)
n=43 Participants
Participants engaged in instructor-led stretching and controlled movements twice weekly for 12 weeks, matched to the physical intensity of BMT without the mindfulness components.
|
Body-Mind Training (BMT/Tai Chi Qigong)
n=45 Participants
Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.
|
|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
Baseline
|
37.8 score on a scale
Standard Deviation 1.9
|
36.7 score on a scale
Standard Deviation 1.4
|
38.7 score on a scale
Standard Deviation 1.4
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
6-week mid-intervention
|
39.1 score on a scale
Standard Deviation 1.9
|
39.5 score on a scale
Standard Deviation 1.5
|
39.9 score on a scale
Standard Deviation 1.4
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
1-week post-intervention
|
39.4 score on a scale
Standard Deviation 1.9
|
40.0 score on a scale
Standard Deviation 1.5
|
40.3 score on a scale
Standard Deviation 1.4
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
3-month post-intervention
|
39.1 score on a scale
Standard Deviation 2.0
|
37.3 score on a scale
Standard Deviation 1.5
|
39.8 score on a scale
Standard Deviation 1.5
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
12-month post-intervention
|
39.1 score on a scale
Standard Deviation 2.3
|
37.7 score on a scale
Standard Deviation 1.7
|
38.0 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention13-item self-report scale assessing fatigue and its impact on daily activities during the past 7 days; higher scores indicate less fatigue (range 0-52). Mean difference between Baseline and timepoint.
Outcome measures
| Measure |
Usual Care (UC/Control)
n=25 Participants
Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.
|
Body Training (BT/Exercise Intensity-Matched Control)
n=43 Participants
Participants engaged in instructor-led stretching and controlled movements twice weekly for 12 weeks, matched to the physical intensity of BMT without the mindfulness components.
|
Body-Mind Training (BMT/Tai Chi Qigong)
n=45 Participants
Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.
|
|---|---|---|---|
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
Change from Baseline and 3-month post-intervention
|
1.34 score on a scale
Interval -1.15 to 3.82
|
0.60 score on a scale
Interval -1.24 to 2.44
|
1.16 score on a scale
Interval -0.55 to 2.87
|
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
Change from Baseline and 12-month post-intervention
|
1.28 score on a scale
Interval -1.85 to 4.41
|
0.96 score on a scale
Interval -1.29 to 3.21
|
-0.63 score on a scale
Interval -2.79 to 1.54
|
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
Change from Baseline and 6-week mid-intervention
|
1.33 score on a scale
Interval -0.84 to 3.5
|
2.72 score on a scale
Interval 0.95 to 4.48
|
1.24 score on a scale
Interval -0.36 to 2.84
|
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
Change from Baseline and 1-week post-intervention
|
1.62 score on a scale
Interval -0.55 to 3.8
|
3.21 score on a scale
Interval 1.49 to 4.92
|
1.69 score on a scale
Interval 0.12 to 3.26
|
Adverse Events
Usual Care (UC/Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Body Training (BT/Exercise Intensity-Matched Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Body-Mind Training (BMT/Tai Chi Qigong)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place