Clinical trial NCT03196037: Feasibility of an 8-week Tai Chi Chuan Intervention for Breast Cancer Survivors
Official title: Feasibility of an 8-week Tai Chi Chuan Intervention for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Cognitive Impairment
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2017-06-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm pre-/post-test non-randomized study design.
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Attendance
timeFrame: post 8-week intervention
measure: Feasibility Pre-Test Completion
timeFrame: Baseline
measure: Feasibility Post-Test Completion
timeFrame: post 8-week intervention
Secondary outcomes:
measure: Recruitment - Frequency Approached for Screening
timeFrame: Baseline
measure: Recruitment - Proportion of Completed Screening
timeFrame: Baseline
measure: Recruitment - Screened Eligible
timeFrame: Baseline
measure: Retention Rate
timeFrame: post 8-week intervention
measure: Recruitment - Enrollment Refusal
timeFrame: Baseline
measure: Retention - Withdrawals
timeFrame: post 8-week intervention
measure: Feasibility of the Different Recruitment Strategies - Screened
timeFrame: Baseline
measure: Feasibility of the Different Recruitment Strategies - Screened Eligible
timeFrame: Baseline
measure: Feasibility of the Different Recruitment Strategies - Enrolled
timeFrame: Baseline
measure: Expectancy/Credibility
timeFrame: Baseline
measure: Acceptability
timeFrame: post 8-week intervention
measure: Intervention Satisfaction Questionnaire
timeFrame: post 8-week intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Program on Integrative Medicine
state: North Carolina
Study officials:
affiliation: University of Rhode Island
name: Aaron T Piepmeier, PhD
role: STUDY_DIRECTOR
References: