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NCT00508794 · ClinicalTrials.gov registry record · NA
Effects of Yoga in Breast Cancer Patients
A NA study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 191
- Enrollment target
NCT00508794: Completed NA study, sponsored by M.D. Anderson Cancer Center.
NCT00508794 is a NA study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 191 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00508794, a NA study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 191 participants
- Enrollment target
Study Summary
In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective. Our specific aims in the proposed study are to: * Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality. * Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability). * Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.
Interventions
- OTHER Questionnaire
- BEHAVIORAL Waitlist Control Group
- BEHAVIORAL Yoga Group
- BEHAVIORAL Stretching Control Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2006-03-09 |
| Est. Completion | 2022-08-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00508794
The ClinicalTrials.gov registry entry for NCT00508794 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 191 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Questionnaire is the first listed.
NCT00508794 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00508794 about?
NCT00508794 is a clinical study titled "Effects of Yoga in Breast Cancer Patients". In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) con...
What is the current status of trial NCT00508794?
This trial is currently completed. It is a NA study. The enrollment target is 191 participants. The study started on 2006-03-09. Estimated completion is 2022-08-11.
What interventions are being tested in trial NCT00508794?
The interventions under investigation include: Questionnaire (OTHER), Waitlist Control Group (BEHAVIORAL), Yoga Group (BEHAVIORAL), Stretching Control Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT00508794?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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