An interventional study of Tai Chi in Cancer, Breast and Cognitive Impairment, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Other
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 4 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Tai Chi
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).
Feasibility - Attendance
Feasibility will be achieved if we observe at least 80% attendance (i.e., at least 13 out of 16 sessions attended).
Time frame: 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).
Time frame: 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).
Time frame: post 8-week intervention
Recruitment - Frequency Approached for Screening
We will describe the frequency approached for screening.
Time frame: Baseline
Recruitment - Proportion of Completed Screening
We will describe the proportion of completed screening (out of approached for screening)
Time frame: Baseline
Recruitment - Screened Eligible
We will describe those screened and found to be eligible (out of total screened).
Time frame: Baseline
Retention Rate
We will describe study retention (number who remain enrolled over 8 weeks/total number originally enrolled).
Time frame: post 8-week intervention
Recruitment - Enrollment Refusal
We will collect reasons for enrollment refusal (as part of the screening survey)
Time frame: Baseline
Retention - Withdrawals
We will collect reasons for study withdrawals.
Time frame: post 8-week intervention
Feasibility of the Different Recruitment Strategies - Screened
For each recruitment strategy, we will describe the frequency screened,
Time frame: 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).
Time frame: Baseline
Feasibility of the Different Recruitment Strategies - Enrolled
For each recruitment strategy, we will describe those enrolled (out of total screened eligible).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: post 8-week intervention
Plan to share: No — No plan.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center