Cancer, BreastNCT03196037
Feasibility of an 8-week Tai Chi Chuan Intervention for Breast Cancer Survivors
A study testing Tai Chi in people with Cancer, Breast and Cognitive Impairment, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Purpose:To gather preliminary data and to determine the feasibility and acceptability of an 8-week Tai Chi intervention for adults cancer survivors (survivors) who report experiencing cognitive impairment, and to perform exploratory analyses to assess improvements in cognitive performance, health-related quality of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Breast, Cognitive Impairment
- What is being tested?
- Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2017to 7 Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Was diagnosed with breast cancer (all stages accepted).
- Currently > 18 years of age
- Age at cancer diagnosis > 18 years.
- Able to engage in moderate intensity exercise as determined by their treating physician. If participant no longer has a treating physician, safety will be determined by following the American College of Sports Medicine (PAR-Q \& YOU) physical activity questionnaire. An answer of "yes" to > one of the seven questions will require the participant to receive written permission from their physician prior to beginning the Tai Chi intervention.
- Not previously engaged in regular exercise training (>1-2d/wk for >30 min/d) in past 6 months.
- Completed chemotherapy treatment for a breast cancer diagnosis.
Show all 12Show fewer
- Cancer chemotherapy treatment completed within last 60 months. Defined as not currently scheduled for or undergoing active treatment (chemotherapy, radiation, surgery). Treatments to prevent or delay recurrence (e.g., breast cancer hormonal therapies) or for maintenance of remission are allowed.
- Report experiencing cognitive impairment following treatment for cancer.
- No psychiatric disorder with psychotic features.
- Able to receive emails from study staff (i.e. for receiving study reminders).
- Able to speak and read English.
- Able to provide informed consent.
Who cannot join
- Unwilling or unable to complete study procedures.
- Currently participating in another study which would preclude participation in this study.
- Has a known additional malignancy that is metastatic, progressing, or requires active treatment.
- Has a neurocognitive disorder of other etiologies, such as Alzheimer's Parkinson's, etc., that might confound the analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Chapel Hill Program on Integrative Medicine
Chapel Hill, North Carolina, 27599-7200
About this study
Purpose:To gather preliminary data and to determine the feasibility and acceptability of an 8-week Tai Chi intervention for adults cancer survivors (survivors) who report experiencing cognitive impairment, and to perform exploratory analyses to assess improvements in cognitive performance, health-related quality of life, brain activity, and blood-based biomarkers.
Participants: Adult survivors (> 18 years old) who report experiencing cognitive impairment and are within 60 months of completion of chemotherapy for treatment of a breast cancer diagnosis.
Procedures (methods): A single arm pre-/post-test non-randomized study design in adult cancer survivors (Enrollment goal N=15; current age ≥ 18 years, treatment completed within 60 months). Outcomes will be assessed at baseline and after the 8-week Tai Chi intervention, and consist of feasibility, acceptability, expectancy/credibility, health-related quality of life, cognitive performance, serum biomarkers, and brain activity.
Read the detailed description
The objective of this study is to gather preliminary data and to determine the feasibility and acceptability of an 8-week Tai Chi intervention for adults within 60 months of having completed chemotherapy for treatment of a cancer diagnosis who report experiencing cognitive impairment (cancer-related cognitive impairment; CRCI). Tai Chi is a form of physical activity that includes an inherent level of cognitive engagement into its performance. Rodent studies provide evidence that including a cognitive component to physical activity (PA) changes its effect on the brain, with aerobic PA inducing angiogenesis and cognitively engaging PA inducing synaptogenesis. Human research with older adults indicates that interventions that combine PA and cognitive engagement produce greater cognitive benefits than PA alone. Experimental and meta-analytic evidence have shown that participation in PA improves cognitive performance in nonclinical and clinical populations, including breast cancer survivors. Importantly, physical activity benefits the same cognitive domains that are negatively affected by CRCI (i.e., attention/processing, memory, executive function). Recently, meta-analytic evidence showed that PA might benefit CRCI. However, in most studies cognitive outcomes are limited to measures of subjective cognitive function rather than objective measures of performance such as neuropsychological assessments or brain activity (e.g., EEG). Research into the effects of Tai Chi on CRCI is sparse, yet promising.
Additionally, research has shown positive effects from Tai Chi on health-related quality of life and cytokines in cancer survivors. To achieve our objective of examining feasibility and acceptability of an 8-week Tai Chi intervention, we will use a single arm pre-/post-test non-randomized study design in adult breast cancer survivors (Enrollment goal N=15; current age ≥ 18 years, treatment completed within 60 months). Outcomes will be assessed at baseline and after the 8-week Tai Chi intervention, and consist of feasibility, acceptability, expectancy/credibility, health-related quality of life, cognitive performance, serum biomarkers, and brain activity. This feasibility study will help identify barriers to recruitment and retention, determine the acceptability of a 8- week Tai Chi intervention for cancer survivors, and provide data for use in designing subsequent studies. Specifically, the findings will inform the design of a randomized controlled trial (RCT) that is sufficiently powered to examine efficacy. The ultimate goal of this research is to create and test a method of investigation into the use of Tai Chi to prevent or mitigate CRCI as well as a method of improving health-related quality of life in cancer survivors.
- Conditions
- Cancer, Breast, Cognitive Impairment
- Being tested
- Tai Chi
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
An 8-week Tai Chi intervention consisting of 75-minute group sessions held twice a week, over 8 weeks (i.e., total of 16 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | The Tai Chi intervention will be lead by an expert Tai Chi instructor with 15 years of teaching experience, and will take place at a local Yoga studio. The 8-week intervention entails two 75-minute sessions per week for a total of 16 sessions. Each session will begin with a 15- minute warm-up followed by 25 minutes of performing basic stances, footwork, upper-body/arm/hand movement, proper body alignment, mental/visual focus, and balance; 30 minutes of instruction in a choreographed form (first section of the Yang style long-form); and ending with a 5-minute cool-down. Receives: Behavioral: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Attendance
Feasibility will be achieved if we observe at least 80% attendance (i.e., at least 13 out of 16 sessions attended).
Measured: post 8-week intervention
Feasibility Pre-Test Completion
Feasibility will be achieved if we observe at least 80% completion. Completion rates will be the proportion of completed measures (number completed measures/total administered measures at pre-test).
Measured: Baseline
Feasibility Post-Test Completion
Feasibility will be achieved if we observe at least 80% completion. Completion rates will be the proportion of completed measures (number completed measures/total administered measures at post-test).
Measured: post 8-week intervention
Secondary outcomes (12)
Recruitment - Frequency Approached for Screening
We will describe the frequency approached for screening.
Measured: Baseline
Recruitment - Proportion of Completed Screening
We will describe the proportion of completed screening (out of approached for screening)
Measured: Baseline
Recruitment - Screened Eligible
We will describe those screened and found to be eligible (out of total screened).
Measured: Baseline
Retention Rate
We will describe study retention (number who remain enrolled over 8 weeks/total number originally enrolled).
Measured: post 8-week intervention
Recruitment - Enrollment Refusal
We will collect reasons for enrollment refusal (as part of the screening survey)
Measured: Baseline
Retention - Withdrawals
We will collect reasons for study withdrawals.
Measured: post 8-week intervention
Feasibility of the Different Recruitment Strategies - Screened
For each recruitment strategy, we will describe the frequency screened,
Measured: Baseline
Feasibility of the Different Recruitment Strategies - Screened Eligible
For each recruitment strategy, we will describe those screened and found to be eligible (out of total screened).
Measured: Baseline
Feasibility of the Different Recruitment Strategies - Enrolled
For each recruitment strategy, we will describe those enrolled (out of total screened eligible).
Measured: Baseline
Expectancy/Credibility
The Expectancy/Credibility Questionnaire will be used to assess baseline expectancy and credibility effects of taking part in the Tai Chi intervention. Responses to six questions will be indicated with a 1 to 9 Likert-type scale, with higher numbers representing greater expectancy/credibility.
Measured: Baseline
Acceptability
The Intervention Satisfaction Scale questions: 1) "Overall, I really enjoyed the Tai Chi intervention" and 2) "I would recommend the Tai Chi intervention to other cancer survivors" will assess acceptability. Acceptability will be achieved if the mean score is 3 or greater (response range: 0=Strongly disagree to 4=Strongly agree).
Measured: post 8-week intervention
Intervention Satisfaction Questionnaire
Three close-ended questions will use a Likert scale (0= strongly disagree to 4=strongly agree) to assess whether the class length, frequency, and duration was satisfactory. Four open-ended questions will collect information on what participants liked or disliked about the Tai Chi intervention, and recommendations for changes to better address cancer survivors' needs and basic study procedures.
Measured: post 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start5 Dec 2017
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm pre-/post-test non-randomized study design.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Aaron T Piepmeier, PhD, Study director, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196037
- Sponsor's protocol ID
- LCCC 1640
- Other IDs
- 2KR871712
- Status last verified
- Mar 2019
- First submitted
- 20 Jun 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an 8-week Tai Chi Chuan Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03196037
- Acronym / sponsor ID
- LCCC 1640
- Conditions
- Cancer, Breast, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- 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.
Purpose:To gather preliminary data and to determine the feasibility and acceptability of an 8-week Tai Chi intervention for adults cancer survivors (survivors) who report experiencing cognitive impairment, and to perform exploratory analyses to assess improvements in cognitive performance, health-related quality of life, brain activity, and blood-based biomarkers.
Participants: Adult survivors (> 18 years old) who report experiencing cognitive impairment and are within 60 months of completion of chemotherapy for treatment of a breast cancer diagnosis.
Procedures (methods): A single arm pre-/post-test non-randomized study design in adult cancer survivors (Enrollment goal N=15; current age ≥ 18 years, treatment completed within 60 months). Outcomes will be assessed at baseline and after the 8-week Tai Chi intervention, and consist of feasibility, acceptability, expectancy/credibility, health-related quality of life, cognitive performance, serum biomarkers, and brain activity.
Detailed description
The objective of this study is to gather preliminary data and to determine the feasibility and acceptability of an 8-week Tai Chi intervention for adults within 60 months of having completed chemotherapy for treatment of a cancer diagnosis who report experiencing cognitive impairment (cancer-related cognitive impairment; CRCI). Tai Chi is a form of physical activity that includes an inherent level of cognitive engagement into its performance. Rodent studies provide evidence that including a cognitive component to physical activity (PA) changes its effect on the brain, with aerobic PA inducing angiogenesis and cognitively engaging PA inducing synaptogenesis. Human research with older adults indicates that interventions that combine PA and cognitive engagement produce greater cognitive benefits than PA alone. Experimental and meta-analytic evidence have shown that participation in PA improves cognitive performance in nonclinical and clinical populations, including breast cancer survivors. Importantly, physical activity benefits the same cognitive domains that are negatively affected by CRCI (i.e., attention/processing, memory, executive function). Recently, meta-analytic evidence showed that PA might benefit CRCI. However, in most studies cognitive outcomes are limited to measures of subjective cognitive function rather than objective measures of performance such as neuropsychological assessments or brain activity (e.g., EEG). Research into the effects of Tai Chi on CRCI is sparse, yet promising.
Additionally, research has shown positive effects from Tai Chi on health-related quality of life and cytokines in cancer survivors. To achieve our objective of examining feasibility and acceptability of an 8-week Tai Chi intervention, we will use a single arm pre-/post-test non-randomized study design in adult breast cancer survivors (Enrollment goal N=15; current age ≥ 18 years, treatment completed within 60 months). Outcomes will be assessed at baseline and after the 8-week Tai Chi intervention, and consist of feasibility, acceptability, expectancy/credibility, health-related quality of life, cognitive performance, serum biomarkers, and brain activity. This feasibility study will help identify barriers to recruitment and retention, determine the acceptability of a 8- week Tai Chi intervention for cancer survivors, and provide data for use in designing subsequent studies. Specifically, the findings will inform the design of a randomized controlled trial (RCT) that is sufficiently powered to examine efficacy. The ultimate goal of this research is to create and test a method of investigation into the use of Tai Chi to prevent or mitigate CRCI as well as a method of improving health-related quality of life in cancer survivors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm pre-/post-test non-randomized study design.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiThe Tai Chi intervention will be lead by an expert Tai Chi instructor with 15 years of teaching experience, and will take place at a local Yoga studio. The 8-week intervention entails two 75-minute sessions per week for a total of 16 sessions. Each session will begin with a 15- minute warm-up followed by 25 minutes of performing basic stances, footwork, upper-body/arm/hand movement, proper body alignment, mental/visual focus, and balance; 30 minutes of instruction in a choreographed form (first section of the Yang style long-form); and ending with a 5-minute cool-down. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Was diagnosed with breast cancer (all stages accepted).
- Currently > 18 years of age
- Age at cancer diagnosis > 18 years.
- Able to engage in moderate intensity exercise as determined by their treating physician. If participant no longer has a treating physician, safety will be determined by following the American College of Sports Medicine (PAR-Q \& YOU) physical activity questionnaire. An answer of "yes" to > one of the seven questions will require the participant to receive written permission from their physician prior to beginning the Tai Chi intervention.
- Not previously engaged in regular exercise training (>1-2d/wk for >30 min/d) in past 6 months.
Key exclusion criteria (4 listed)
- Unwilling or unable to complete study procedures.
- Currently participating in another study which would preclude participation in this study.
- Has a known additional malignancy that is metastatic, progressing, or requires active treatment.
- Has a neurocognitive disorder of other etiologies, such as Alzheimer's Parkinson's, etc., that might confound the analysis
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 |
|---|---|---|
| Tai ChiAn 8-week Tai Chi intervention consisting of 75-minute group sessions held twice a week, over 8 weeks (i.e., total of 16 sessions). | Behavioural | Tai Chi |
Primary outcome
Feasibility - Attendance
Time frame: post 8-week intervention
Feasibility will be achieved if we observe at least 80% attendance (i.e., at least 13 out of 16 sessions attended).
Feasibility Pre-Test Completion
Time frame: Baseline
Feasibility will be achieved if we observe at least 80% completion. Completion rates will be the proportion of completed measures (number completed measures/total administered measures at pre-test).
Feasibility Post-Test Completion
Time frame: post 8-week intervention
Feasibility will be achieved if we observe at least 80% completion. Completion rates will be the proportion of completed measures (number completed measures/total administered measures at post-test).
12 secondary outcomes
Recruitment - Frequency Approached for Screening
Time frame: Baseline
Recruitment - Proportion of Completed Screening
Time frame: Baseline
Recruitment - Screened Eligible
Time frame: Baseline
Retention Rate
Time frame: post 8-week intervention
Recruitment - Enrollment Refusal
Time frame: Baseline
Retention - Withdrawals
Time frame: post 8-week intervention
Feasibility of the Different Recruitment Strategies - Screened
Time frame: Baseline
Feasibility of the Different Recruitment Strategies - Screened Eligible
Time frame: Baseline
Feasibility of the Different Recruitment Strategies - Enrolled
Time frame: Baseline
Expectancy/Credibility
Time frame: Baseline
Acceptability
Time frame: post 8-week intervention
Intervention Satisfaction Questionnaire
Time frame: post 8-week intervention
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 7 Mar 2019.
- Individual participant dataSharing planned: No. No plan.
Related trials for Cancer, Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Aaron T Piepmeier, PhD study director
University of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi in people with Cancer, Breast and Cognitive Impairment, run by UNC Lineberger Comprehensive Cancer Center 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 12 inclusion and 4 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 7 Mar 2019. 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. 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?
Feasibility - Attendance (time frame: post 8-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.