FatigueNCT02690116
Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors
A study testing Qigong/Tai Chi Easy and Educational Support in people with Fatigue, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to test whether Meditative Movement (based on a standardized and tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other symptoms in women after treatment for breast cancer than (a) a non-meditative "sham" Qigong active intervention and (b) an inactive… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Qigong/Tai Chi Easy and Educational Support
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with breast cancer, stage 0-III
- Between 6 months and 10 years past primary treatment
- Post-menopausal
- Experiencing fatigue (scoring < 75 on "Vitality" scale of Short Form (SF)-36)
- English-speaking or Spanish-speaking
Who cannot join
- Women who are unable to stand for 10-minute segments
- Women who have had substantial experience with mind-body practices that blend movement with mindfulness/breathing techniques, such as Yoga, Tai Chi, or Qigong
- Women who work night shifts (fatigue-related factor)
- Restless leg syndrome (fatigue-related factor)
- Hypothyroidism (fatigue-related factor)
- Currently diagnosed with anemia (fatigue-related factor)
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- Uncontrolled diabetes (fatigue-related factor)
- Major severe clinical depression (fatigue-related factor)
- Use of antihistamine, cyclosporins, corticosteroids, sleeping aids
- Regular use of alcohol (more than 2 drinks per day)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test whether Meditative Movement (based on a standardized and tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other symptoms in women after treatment for breast cancer than (a) a non-meditative "sham" Qigong active intervention and (b) an inactive education / support group.
Read the detailed description
Patients with breast cancer often report fatigue and other associated symptoms that persist for months, even years, after treatment ends. In a recent pilot study of Qigong/Tai Chi Easy (QG/TCE, a low-intensity form of Meditative Movement), fatigued breast cancer survivors experienced greater improvements in fatigue (medium effect size, .56); compared to a "sham" Qigong control intervention (also low-intensity activity). Trends for improvement compared to control were found for sleep quality and depression. Recruitment for the single-site implementation was steady, and feasible. To build upon the promise of this pilot study, and to further test intervention components that may elucidate what aspects of the intervention have the most impact, a three-group, randomized trial will be undertaken to test effects of an 8-week QG/TCE intervention on fatigue and other symptoms at the end of 8 weeks, and 24 weeks post-intervention. 246 (attrition to 210) women who are 6 months to 10 years past treatment for Stage 0- III breast cancer, aged 45-75, and post-menopausal, will be randomized into one of three study arms. Two comparison groups will be used, an educational support (ES) group control and an active sham Qigong (SQG) group with movements that are similar to and with the same level of physical activity intensity as QG/TCE, but without the focus on the breath and meditative state. These treatments allow for separation of effects associated with gentle exercise alone (controlled in SQG) and education/social support alone without any exercise (controlled in ES) relative to the mind-body practice of QG/TCE, to distinguish unique effects of the meditative and breath foci. The study will be implemented in two sites in a large, metropolitan area, including one low-income hospital (and catchment neighborhood) with larger numbers of Latina survivors where our research team has extensive community connections and cultural experience implementing exercise and meditative movement programs. Psychometrics and biomarkers related to symptoms before and after the interventions will be examined to further our understanding of the mechanisms associated with effects of QG/TCE, as distinct from ES and SQG.
- Conditions
- Fatigue
- Being tested
- Qigong/Tai Chi Easy, Sham Qigong, Educational Support
- Keywords
- Meditative movement, Breast cancer survivors, Qigong, Tai Chi Easy, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong/Tai Chi EasyOther
Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.
Sham QigongOther
Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.
Educational SupportOther
Class times and at-home readings correspond to dose set for the QG/TCE and SQG class times and home practice. Participants will attend one 60-minute class per week for the 8 weeks, with a recommended home practice time (reading, workbook completion) of 2 1/2 hours each week.
| Study group | Role | What they receive |
|---|---|---|
| Qigong/Tai Chi Easy | Experimental | The Qigong/Tai Chi Easy (QG/TCE) intervention has been standardized, manualized, and has a formal training program for instructors from the Institute of Integral Qigong and Tai Chi (IIQTC). Receives: Other: Qigong/Tai Chi Easy |
| Sham Qigong | Sham comparator | This active control group uses a gentle movement intervention, with similar types of movements with the same energy expenditure, but without the meditative states and breath focus as QG/TCE (validated in the pilot study using the Meditative Movement Inventory). Receives: Other: Sham Qigong |
| Educational Support | Active comparator | The Recovery Support Group will consist of a classroom-style intervention, designed to educate, engage interaction, and maintain participation and attention over 8 weeks. This group will include readings/discussions specific to breast cancer, and social interaction facilitation. Receives: Other: Educational Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Symptom Inventory
Fatigue
Measured: Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.
Secondary outcomes (8)
Profile of Mood States Short Form (POMS-SF)
Anxiety and depression
Measured: Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months.
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG)
Cognitive function
Measured: Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months.
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality
Measured: Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months
Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ)
Physical activity
Measured: Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months
Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits
Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ)
Measured: Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks
Diurnal salivary samples (enzyme assay)
Salivary cortisol
Measured: Change from baseline salivary cortisol to salivary cortisol at 8 weeks
ActiGraph GT3X activity monitor
Objective measurement of physical activity
Measured: Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months
ActiGraph GT3X activity monitor
Objective measurement of sleep quality
Measured: Change from baseline objective sleep quality to objective sleep quality at 8 weeks and objective sleep quality at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Linda Larkey, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690116
- Sponsor's protocol ID
- 1R01CA182901-01A1
- Status last verified
- Jun 2021
- First submitted
- 6 Jan 2016
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
James DL, Maxfield M, Han S, Hawley NA, Petrov ME, Sears DD, Vance DE, Larkey LK. Cognitive function, mood and sleep changes in response to a Tai Chi/Qigong intervention among older breast cancer survivors: an exploratory analysis. Front Cognit. 2024;3:1402873. doi: 10.3389/fcogn.2024.1402873. Epub 2024 Aug 14.
PubMed 42221750Larkey LK, James DL, Han S, Weihs K, Jahnke R, Oh B, Kim SW, Huberty J, Petrov ME, Martin D, Howe N, Hook J, Soltero E, Rao S, Northfelt D. Randomized controlled trial testing Tai Chi Easy/Qigong and Sham Qigong on breast cancer survivors' fatigue and associated symptoms. Complement Ther Clin Pract. 2025 Nov;61:102014. doi: 10.1016/j.ctcp.2025.102014. Epub 2025 Jul 8.
PubMed 40651067
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02690116
- Acronym / sponsor ID
- 1R01CA182901-01A1
- Conditions
- Fatigue
- Keywords
- Meditative movement, Breast cancer survivors, Qigong, Tai Chi Easy, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- University of Arizona, Mayo Clinic
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether Meditative Movement (based on a standardized and tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other symptoms in women after treatment for breast cancer than (a) a non-meditative "sham" Qigong active intervention and (b) an inactive education / support group.
Detailed description
Patients with breast cancer often report fatigue and other associated symptoms that persist for months, even years, after treatment ends. In a recent pilot study of Qigong/Tai Chi Easy (QG/TCE, a low-intensity form of Meditative Movement), fatigued breast cancer survivors experienced greater improvements in fatigue (medium effect size, .56); compared to a "sham" Qigong control intervention (also low-intensity activity). Trends for improvement compared to control were found for sleep quality and depression. Recruitment for the single-site implementation was steady, and feasible. To build upon the promise of this pilot study, and to further test intervention components that may elucidate what aspects of the intervention have the most impact, a three-group, randomized trial will be undertaken to test effects of an 8-week QG/TCE intervention on fatigue and other symptoms at the end of 8 weeks, and 24 weeks post-intervention. 246 (attrition to 210) women who are 6 months to 10 years past treatment for Stage 0- III breast cancer, aged 45-75, and post-menopausal, will be randomized into one of three study arms. Two comparison groups will be used, an educational support (ES) group control and an active sham Qigong (SQG) group with movements that are similar to and with the same level of physical activity intensity as QG/TCE, but without the focus on the breath and meditative state. These treatments allow for separation of effects associated with gentle exercise alone (controlled in SQG) and education/social support alone without any exercise (controlled in ES) relative to the mind-body practice of QG/TCE, to distinguish unique effects of the meditative and breath foci. The study will be implemented in two sites in a large, metropolitan area, including one low-income hospital (and catchment neighborhood) with larger numbers of Latina survivors where our research team has extensive community connections and cultural experience implementing exercise and meditative movement programs. Psychometrics and biomarkers related to symptoms before and after the interventions will be examined to further our understanding of the mechanisms associated with effects of QG/TCE, as distinct from ES and SQG.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Qigong/Tai Chi Easy | Experimental | Other: Qigong/Tai Chi EasyThe Qigong/Tai Chi Easy (QG/TCE) intervention has been standardized, manualized, and has a formal training program for instructors from the Institute of Integral Qigong and Tai Chi (IIQTC). |
| Sham Qigong | Sham comparator | Other: Sham QigongThis active control group uses a gentle movement intervention, with similar types of movements with the same energy expenditure, but without the meditative states and breath focus as QG/TCE (validated in the pilot study using the Meditative Movement Inventory). |
| Educational Support | Active comparator | Other: Educational SupportThe Recovery Support Group will consist of a classroom-style intervention, designed to educate, engage interaction, and maintain participation and attention over 8 weeks. This group will include readings/discussions specific to breast cancer, and social interaction facilitation. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with breast cancer, stage 0-III
- Between 6 months and 10 years past primary treatment
- Post-menopausal
- Experiencing fatigue (scoring < 75 on "Vitality" scale of Short Form (SF)-36)
- English-speaking or Spanish-speaking
Key exclusion criteria (10 listed)
- Women who are unable to stand for 10-minute segments
- Women who have had substantial experience with mind-body practices that blend movement with mindfulness/breathing techniques, such as Yoga, Tai Chi, or Qigong
- Women who work night shifts (fatigue-related factor)
- Restless leg syndrome (fatigue-related factor)
- Hypothyroidism (fatigue-related factor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong/Tai Chi EasyClasses will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week. | Other | Qigong/Tai Chi Easy |
| Sham QigongClasses will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week. | Other | Sham Qigong |
| Educational SupportClass times and at-home readings correspond to dose set for the QG/TCE and SQG class times and home practice. Participants will attend one 60-minute class per week for the 8 weeks, with a recommended home practice time (reading, workbook completion) of 2 1/2 hours each week. | Other | Educational Support |
Primary outcome
Fatigue Symptom Inventory
Time frame: Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.
Fatigue
8 secondary outcomes
Profile of Mood States Short Form (POMS-SF)
Time frame: Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months.
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG)
Time frame: Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months
Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ)
Time frame: Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months
Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits
Time frame: Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks
Diurnal salivary samples (enzyme assay)
Time frame: Change from baseline salivary cortisol to salivary cortisol at 8 weeks
ActiGraph GT3X activity monitor
Time frame: Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months
ActiGraph GT3X activity monitor
Time frame: Change from baseline objective sleep quality to objective sleep quality at 8 weeks and objective sleep quality at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Derived from this study: PubMed 42221750James DL, Maxfield M, Han S, Hawley NA, Petrov ME, Sears DD, Vance DE, Larkey LK. Cognitive function, mood and sleep changes in response to a Tai Chi/Qigong intervention among older breast cancer survivors: an exploratory analysis. Front Cognit. 2024;3:1402873. doi: 10.3389/fcogn.2024.1402873. Epub 2024 Aug 14.
- Derived from this study: PubMed 40651067Larkey LK, James DL, Han S, Weihs K, Jahnke R, Oh B, Kim SW, Huberty J, Petrov ME, Martin D, Howe N, Hook J, Soltero E, Rao S, Northfelt D. Randomized controlled trial testing Tai Chi Easy/Qigong and Sham Qigong on breast cancer survivors' fatigue and associated symptoms. Complement Ther Clin Pract. 2025 Nov;61:102014. doi: 10.1016/j.ctcp.2025.102014. Epub 2025 Jul 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Larkey, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong/Tai Chi Easy and Educational Support in people with Fatigue, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Symptom Inventory (time frame: Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02690116, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.