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

NCT03196037 | Completed DMC

• 2 other identifiers: LCCC 16402KR871712
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• Feasibility - Attendance

  Feasibility will be achieved if we observe at least 80% attendance (i.e., at least 13 out of 16 sessions attended).

  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).

  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).

  post 8-week intervention

Secondary Outcomes (12)

• Recruitment - Frequency Approached for Screening

  Baseline

• Recruitment - Proportion of Completed Screening

  Baseline

• Recruitment - Screened Eligible

  Baseline

• Retention Rate

  post 8-week intervention

• Recruitment - Enrollment Refusal

  Baseline

Study Arms (1)

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.

Behavioral: Tai Chi

Interventions

Tai Chi BEHAVIORAL

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).

Tai Chi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

UNC Chapel Hill Program on Integrative Medicine

Chapel Hill, North Carolina, 27599-7200, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Cognitive Dysfunction

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Aaron T Piepmeier, PhD

  University of Rhode Island

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm pre-/post-test non-randomized study design.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: December 5, 2017
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)