TriangleNCT03345563 · 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
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).
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.
Reported safety
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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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-malignant-kidney-neoplasm
- 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