Feasibility of an 8-week Tai Chi Chuan Intervention for Breast Cancer Survivors



Status:Completed
Conditions:Breast Cancer, Cognitive Studies, Cognitive Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:December 5, 2017
End Date:December 7, 2018

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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.

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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
We found this trial at
1
site
450 West Drive
Chapel Hill, North Carolina 27599
Phone: 336-937-3757
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from
Chapel Hill, NC
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