Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors

NCT02690116 | Completed

• 1 other identifier: 1R01CA182901-01A1
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether Meditative Movement (based on a standardized and tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other symptoms in women after treatment for breast cancer than (a) a non-meditative "sham" Qigong active intervention and (b) an inactive education / support group.

Conditions

Fatigue

Keywords

Meditative movement; Breast cancer survivors; Qigong; Tai Chi Easy; Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue Symptom Inventory

  Fatigue

  Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.

Secondary Outcomes (8)

• Profile of Mood States Short Form (POMS-SF)

  Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months.

• Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG)

  Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months.

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months

• Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ)

  Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months

• Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits

  Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks

Other Outcomes (1)

• Functional Assessment of Cancer Therapy-Cognitive Function Neuropathy (FACT-COGNtx)

  Change from baseline peripheral neuropathy to peripheral neuropathy at 8 weeks and peripheral neuropathy at 6 months

Study Arms (3)

Qigong/Tai Chi Easy

EXPERIMENTAL

The Qigong/Tai Chi Easy (QG/TCE) intervention has been standardized, manualized, and has a formal training program for instructors from the Institute of Integral Qigong and Tai Chi (IIQTC).

Other: Qigong/Tai Chi Easy

Sham Qigong

SHAM COMPARATOR

This active control group uses a gentle movement intervention, with similar types of movements with the same energy expenditure, but without the meditative states and breath focus as QG/TCE (validated in the pilot study using the Meditative Movement Inventory).

Other: Sham Qigong

Educational Support

ACTIVE COMPARATOR

The Recovery Support Group will consist of a classroom-style intervention, designed to educate, engage interaction, and maintain participation and attention over 8 weeks. This group will include readings/discussions specific to breast cancer, and social interaction facilitation.

Other: Educational Support

Interventions

Qigong/Tai Chi Easy OTHER

Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.

Qigong/Tai Chi Easy

Sham Qigong OTHER

Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.

Sham Qigong

Educational Support OTHER

Class times and at-home readings correspond to dose set for the QG/TCE and SQG class times and home practice. Participants will attend one 60-minute class per week for the 8 weeks, with a recommended home practice time (reading, workbook completion) of 2 1/2 hours each week.

Educational Support

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with breast cancer, stage 0-III
• Between 6 months and 10 years past primary treatment
• Post-menopausal
• Experiencing fatigue (scoring \< 75 on "Vitality" scale of Short Form (SF)-36)
• English-speaking or Spanish-speaking

You may not qualify if:

• Women who are unable to stand for 10-minute segments
• Women who have had substantial experience with mind-body practices that blend movement with mindfulness/breathing techniques, such as Yoga, Tai Chi, or Qigong
• Women who work night shifts (fatigue-related factor)
• Restless leg syndrome (fatigue-related factor)
• Hypothyroidism (fatigue-related factor)
• Currently diagnosed with anemia (fatigue-related factor)
• Uncontrolled diabetes (fatigue-related factor)
• Major severe clinical depression (fatigue-related factor)
• Use of antihistamine, cyclosporins, corticosteroids, sleeping aids
• Regular use of alcohol (more than 2 drinks per day)

Sponsors & Collaborators

• Arizona State University: lead
• University of Arizona: collaborator
• Mayo Clinic: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Training Support

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Financial Support; Economics; Health Care Economics and Organizations

Study Officials

• Linda Larkey, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: February 24, 2016
• Study Start: February 1, 2016
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)