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NCT01305044 · ClinicalTrials.gov registry record · Phase 2
The HEALS Project - Health Education and Active Living for Surviving Seniors
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01305044: Completed Phase 2 study, sponsored by University of Utah.
NCT01305044 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01305044, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
Persons over age 65 years constitute a large and growing population of cancer survivors. Available data indicate that both short- and long-term female breast cancer survivors report more limitations related to strength and mobility than women with cancers of other sites and women without a personal history of cancer. Further, better mental health among breast cancer survivors has been shown to protect against physical decline and overall quality of life. The combination of mental and physical interventions may result in substantial improvements in quality of life. Tai Chi Chih (TCC), a form of mind-body exercise, is one such intervention. TCC may be particularly suited toward elderly breast cancer survivors with impaired physical and/or mental functioning, yet despite its increasing popularity and benefits in healthy and diseased populations, its benefits have never been scientifically evaluated in this population. The overarching goal of this study is to conduct preparatory work regarding the effects of TCC on quality of life and physical function that will underpin future definitive trials of TCC in elderly cancer survivors. As part of this 12-week trial, participants will be randomized to a TCC or a health education control group (HEC). Establishment of meaningful interventions that facilitate a more positive cancer survival experience in old age is an important issue; there are substantial public health and clinical benefits should a TC intervention be successful in this patient population.
Primary Outcome
The 12-week intervention assessed retention in the study (percentage of how many participants remained enrolled the entire intervention), class attendance (percentage out of possible classes)
Interventions
- BEHAVIORAL Tai Chi Chih
- BEHAVIORAL Health Education Classes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01305044 record still lists
NCT01305044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Tai Chi Chih is the first listed.
NCT01305044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01305044 about?
NCT01305044 is a clinical study titled "The HEALS Project - Health Education and Active Living for Surviving Seniors". Persons over age 65 years constitute a large and growing population of cancer survivors. Available data indicate that both short- and long-term female breast cancer survivors report more limitations related to strength and mobility than women with cancers of other sites and women without a personal ...
What is the current status of trial NCT01305044?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2009-12. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01305044?
The interventions under investigation include: Tai Chi Chih (BEHAVIORAL), Health Education Classes (BEHAVIORAL).
Who is sponsoring clinical trial NCT01305044?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01305044's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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