NCT03345563 · STUDY IN CONTEXT

Project HERO: Health Empowerment & Recovery Outcomes

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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).

Source null

→

primary · POSTED

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). Mean difference between Baseline and timepoint.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-rectal-cancer
nct id: NCT03345563
trial label: Project HERO: Health Empowerment & Recovery Outcomes
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
outcome key
om-0000
source section id
NCT03345563-om-0000
source outcome index
0
endpoint
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
endpoint definition
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).
time origin
Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
outcome key
om-0001
source section id
NCT03345563-om-0001
source outcome index
1
endpoint
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
endpoint definition
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). Mean difference between Baseline and timepoint.
time origin
Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
outcome key
om-0000
arm key
OG000
arm label
Usual Care (UC/Control)
regimen
Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345563-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
outcome key
om-0000
arm key
OG001
arm label
Body Training (BT/Exercise Intensity-Matched Control)
regimen
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.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345563-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
outcome key
om-0000
arm key
OG002
arm label
Body-Mind Training (BMT/Tai Chi Qigong)
regimen
Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345563-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
outcome key
om-0001
arm key
OG000
arm label
Usual Care (UC/Control)
regimen
Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345563-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
outcome key
om-0001
arm key
OG001
arm label
Body Training (BT/Exercise Intensity-Matched Control)
regimen
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.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345563-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
outcome key
om-0001
arm key
OG002
arm label
Body-Mind Training (BMT/Tai Chi Qigong)
regimen
Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345563-om-0001#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
harm key
EG000
source section id
NCT03345563-ae
event group key
EG000
event group label
Usual Care (UC/Control)
serious affected
0
serious at risk
25
other affected
0
other at risk
25
frequency threshold
0
collection period
Time of enrollment to study completion, an average of 12 months
event definition
No adverse event was noted in the trial. However, an all-cause mortality event occurred in the BT arm, unrelated to the intervention or the trial.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
harm key
EG001
source section id
NCT03345563-ae
event group key
EG001
event group label
Body Training (BT/Exercise Intensity-Matched Control)
serious affected
0
serious at risk
43
other affected
0
other at risk
43
frequency threshold
0
collection period
Time of enrollment to study completion, an average of 12 months
event definition
No adverse event was noted in the trial. However, an all-cause mortality event occurred in the BT arm, unrelated to the intervention or the trial.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer
nct id
NCT03345563
harm key
EG002
source section id
NCT03345563-ae
event group key
EG002
event group label
Body-Mind Training (BMT/Tai Chi Qigong)
serious affected
0
serious at risk
45
other affected
0
other at risk
45
frequency threshold
0
collection period
Time of enrollment to study completion, an average of 12 months
event definition
No adverse event was noted in the trial. However, an all-cause mortality event occurred in the BT arm, unrelated to the intervention or the trial.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice