Caring for Caregivers With Mind-body Exercise
1 other identifier
interventional
47
1 country
1
Brief Summary
This pilot study will lay the foundation for the first large-scale trial evaluating the psychosocial and physical health benefits of a widely available and promising Qigong intervention (Eight Brocades) for distressed cancer caregivers (CCGs). CCGs represent a well-defined, large and growing subset of a larger population of CGs that overlap greatly in the constellations of morbidities that lead to high levels of distress. The multi-modal nature of the Eight Brocades Qigong regimen explicitly targets both psychosocial and physical functional symptoms, thus expanding the scope of mind-body studies for CGs to date, which have largely focused on stress management and psychological well-being. This pilot study, and the eventual large-scale comparative effectiveness trial, explores the effectiveness of Qigong training delivered in both community-based group classes and through self-guided internet-based modules supplemented with one-on-one virtual learning support. This trial will be the first to explore the delivery of Qigong to caregivers using an internet-based program, potentially leading to wider accessibility to mind-body therapies, and providing an alternative to community-based group-class learning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2019
CompletedFirst Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedDecember 30, 2021
December 1, 2021
3.3 years
June 21, 2019
December 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Eligibility of recruited participants
Eligibility assessed by the % of eligible participants that are willing to consent to participate in the study.
6 months
Adherence to Intervention
Intervention adherence assessed by the rate of compliance with classes and home practice.
6 months
Secondary Outcomes (11)
Center for Epidemiological Studies Depression Scale Revised (CESD-R-10)
6 months
Brief Fatigue Inventory (BFI)
6 months
Pittsburgh Sleep Quality Index (PSQI), Sleep Disturbances
6 months
Caregiver Burden Scale (CBS)
6 months
Godin Leisure-Time Exercise Questionnaire, Physical Activity
6 months
- +6 more secondary outcomes
Study Arms (3)
Community-based Qigong Group
EXPERIMENTALParticipants randomized into this group follow one, 75 minutes class per week supplemented by home practice for 20 minutes on 3 additional days.
Internet-based Qigong Group
EXPERIMENTALParticipants randomized into this group follow two online sessions for 40 minutes each, also supplemented by home practice for 20 minutes on 3 additional days.
Self-Care Control Group
NO INTERVENTIONThe Self-care control group, will be requested not to practice any Qigong during the study. Participants will be provided with an educational book on caregiving that includes self-guided activities related to caregiving and caregiver health (The Caregiver Helpbook: Powerful Tools for Caregiving). The book's evidence-based program is designed to provide caregivers the tools to increase their self-care and their confidence to handle difficult situations, emotions, and decisions. In addition, study staff will call participants in the self-care control group once a month.
Interventions
The Community-based Qigong group, will attend one 75 minute long Qigong class per week for 12 weeks. Additionally, participants practice Qigong at home for 20 minutes a day, 3 days a week. Printed materials will be provided to guide home practice.
The Internet-guided Qigong group will be given a computer tablet to access online Qigong classes. All participants assigned to this group will be provided with a tutorial to use the Qigong program by the research coordinator. Participants will be asked to follow a 40 minute long Qigong class twice a week for 12 weeks, and to practice an additional 20 minutes a day, 3 days a week. All sessions will be completed at home.
Eligibility Criteria
You may qualify if:
- Participant is a spouse, partner, family member, or friend providing physical, emotional, and/or financial support for a cancer patient.
- Participant is able to understand, speak, and read English.
- Participant has a minimum level of 3 on the National Comprehensive Cancer Network's (NCCN) Distress Thermometer adapted for caregivers.
- Participant is able to provide informed consent.
You may not qualify if:
- Participant does not have an unstable illness (e.g., recent hospitalization, unstable cardiovascular disease, active cancer).
- Participant does not have a psychiatric disorders (e.g., unmanaged depression or psychosis, substance abuse, severe personality disorder)
- Participant does not have a degenerative neuromuscular condition (e.g., Parkinson's disease, multiple sclerosis).
- Participant does not have an inability to walk continuously for 15 minutes.
- Participant does not have a recent history of attending regular Qigong or similar (e.g., yoga or Tai Chi) classes defined as 20 or more classes in the past 6 months.
- Participation is not currently engaged in more than 240 minutes of moderate-intensity exercise per week.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Houstonlead
- Brigham and Women's Hospitalcollaborator
- Texas Woman's Universitycollaborator
Study Sites (1)
University of Houston
Houston, Texas, 77004, United States
Related Publications (130)
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PMID: 26362690BACKGROUNDSalmoirago-Blotcher E, Wayne P, Bock BC, Dunsiger S, Wu WC, Stabile L, Yeh G. Design and methods of the Gentle Cardiac Rehabilitation Study--A behavioral study of tai chi exercise for patients not attending cardiac rehabilitation. Contemp Clin Trials. 2015 Jul;43:243-51. doi: 10.1016/j.cct.2015.06.020. Epub 2015 Jun 24.
PMID: 26115880BACKGROUNDSalmoirago-Blotcher E, Wayne PM, Dunsiger S, Krol J, Breault C, Bock BC, Wu WC, Yeh GY. Tai Chi Is a Promising Exercise Option for Patients With Coronary Heart Disease Declining Cardiac Rehabilitation. J Am Heart Assoc. 2017 Oct 11;6(10):e006603. doi: 10.1161/JAHA.117.006603.
PMID: 29021268BACKGROUNDWayne PM, Gow BJ, Costa MD, Peng CK, Lipsitz LA, Hausdorff JM, Davis RB, Walsh JN, Lough M, Novak V, Yeh GY, Ahn AC, Macklin EA, Manor B. Complexity-Based Measures Inform Effects of Tai Chi Training on Standing Postural Control: Cross-Sectional and Randomized Trial Studies. PLoS One. 2014 Dec 10;9(12):e114731. doi: 10.1371/journal.pone.0114731. eCollection 2014.
PMID: 25494333BACKGROUNDYeh GY, Chan CW, Wayne PM, Conboy L. The Impact of Tai Chi Exercise on Self-Efficacy, Social Support, and Empowerment in Heart Failure: Insights from a Qualitative Sub-Study from a Randomized Controlled Trial. PLoS One. 2016 May 13;11(5):e0154678. doi: 10.1371/journal.pone.0154678. eCollection 2016.
PMID: 27177041BACKGROUNDYeh GY, Mu L, Davis RB, Wayne PM. Correlates of Exercise Self-efficacy in a Randomized Trial of Mind-Body Exercise in Patients With Chronic Heart Failure. J Cardiopulm Rehabil Prev. 2016 May-Jun;36(3):186-94. doi: 10.1097/HCR.0000000000000170.
PMID: 26959498BACKGROUNDYeh GY, Wayne PM, Litrownik D, Roberts DH, Davis RB, Moy ML. Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial. Trials. 2014 Aug 28;15:337. doi: 10.1186/1745-6215-15-337.
PMID: 25168853BACKGROUNDYeung AS, Feng R, Kim DJH, Wayne PM, Yeh GY, Baer L, Lee OE, Denninger JW, Benson H, Fricchione GL, Alpert J, Fava M. A Pilot, Randomized Controlled Study of Tai Chi With Passive and Active Controls in the Treatment of Depressed Chinese Americans. J Clin Psychiatry. 2017 May;78(5):e522-e528. doi: 10.4088/JCP.16m10772.
PMID: 28570792BACKGROUNDBudhrani PH, Lengacher CA, Kip K, Tofthagen C, Jim H. An integrative review of subjective and objective measures of sleep disturbances in breast cancer survivors. Clin J Oncol Nurs. 2015 Apr;19(2):185-91. doi: 10.1188/15.CJON.185-191.
PMID: 25840384BACKGROUNDBudhrani PH, Lengacher CA, Kip KE, Tofthagen C, Jim H. Minority Breast Cancer Survivors: The Association between Race/Ethnicity, Objective Sleep Disturbances, and Physical and Psychological Symptoms. Nurs Res Pract. 2014;2014:858403. doi: 10.1155/2014/858403. Epub 2014 Jul 2.
PMID: 25101174BACKGROUNDLengacher CA, Johnson-Mallard V, Barta M, Fitzgerald S, Moscoso MS, Post-White J, Jacobsen PB, Molinari Shelton M, Le N, Budhrani P, Goodman M, Kip KE. Feasibility of a mindfulness-based stress reduction program for early-stage breast cancer survivors. J Holist Nurs. 2011 Jun;29(2):107-17. doi: 10.1177/0898010110385938. Epub 2010 Nov 1.
PMID: 21041554BACKGROUNDLengacher CA, Reich RR, Kip KE, Barta M, Ramesar S, Paterson CL, Moscoso MS, Carranza I, Budhrani PH, Kim SJ, Park HY, Jacobsen PB, Schell MJ, Jim HS, Post-White J, Farias JR, Park JY. Influence of mindfulness-based stress reduction (MBSR) on telomerase activity in women with breast cancer (BC). Biol Res Nurs. 2014 Oct;16(4):438-47. doi: 10.1177/1099800413519495. Epub 2014 Jan 30.
PMID: 24486564BACKGROUNDLengacher CA, Reich RR, Paterson CL, Jim HS, Ramesar S, Alinat CB, Budhrani PH, Farias JR, Shelton MM, Moscoso MS, Park JY, Kip KE. The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial. Psychooncology. 2015 Apr;24(4):424-32. doi: 10.1002/pon.3603. Epub 2014 Jun 18.
PMID: 24943918BACKGROUNDLengacher CA, Reich RR, Post-White J, Moscoso M, Shelton MM, Barta M, Le N, Budhrani P. Mindfulness based stress reduction in post-treatment breast cancer patients: an examination of symptoms and symptom clusters. J Behav Med. 2012 Feb;35(1):86-94. doi: 10.1007/s10865-011-9346-4. Epub 2011 Apr 20.
PMID: 21506018BACKGROUNDLengacher CA, Shelton MM, Reich RR, Barta MK, Johnson-Mallard V, Moscoso MS, Paterson C, Ramesar S, Budhrani P, Carranza I, Lucas J, Jacobsen PB, Goodman MJ, Kip KE. Mindfulness based stress reduction (MBSR(BC)) in breast cancer: evaluating fear of recurrence (FOR) as a mediator of psychological and physical symptoms in a randomized control trial (RCT). J Behav Med. 2014 Apr;37(2):185-95. doi: 10.1007/s10865-012-9473-6. Epub 2012 Nov 27.
PMID: 23184061BACKGROUNDMcQuade JL, Prinsloo S, Chang DZ, Spelman A, Wei Q, Basen-Engquist K, Harrison C, Zhang Z, Kuban D, Lee A, Cohen L. Qigong/tai chi for sleep and fatigue in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. Psychooncology. 2017 Nov;26(11):1936-1943. doi: 10.1002/pon.4256. Epub 2016 Sep 20.
PMID: 27548839BACKGROUNDYeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, Phillips RS. Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial. Am J Med. 2004 Oct 15;117(8):541-8. doi: 10.1016/j.amjmed.2004.04.016.
PMID: 15465501BACKGROUNDYeh GY, McCarthy EP, Wayne PM, Stevenson LW, Wood MJ, Forman D, Davis RB, Phillips RS. Tai chi exercise in patients with chronic heart failure: a randomized clinical trial. Arch Intern Med. 2011 Apr 25;171(8):750-7. doi: 10.1001/archinternmed.2011.150.
PMID: 21518942BACKGROUNDYeh GY, Wood MJ, Wayne PM, Quilty MT, Stevenson LW, Davis RB, Phillips RS, Forman DE. Tai chi in patients with heart failure with preserved ejection fraction. Congest Heart Fail. 2013 Mar-Apr;19(2):77-84. doi: 10.1111/chf.12005. Epub 2012 Oct 12.
PMID: 23057654BACKGROUNDLi L, Manor B. Long term Tai Chi exercise improves physical performance among people with peripheral neuropathy. Am J Chin Med. 2010;38(3):449-59. doi: 10.1142/S0192415X1000797X.
PMID: 20503464BACKGROUNDManor B, Lipsitz LA, Wayne PM, Peng CK, Li L. Complexity-based measures inform Tai Chi's impact on standing postural control in older adults with peripheral neuropathy. BMC Complement Altern Med. 2013 Apr 16;13:87. doi: 10.1186/1472-6882-13-87.
PMID: 23587193BACKGROUNDMcGibbon CA, Krebs DE, Wolf SL, Wayne PM, Scarborough DM, Parker SW. Tai Chi and vestibular rehabilitation effects on gaze and whole-body stability. J Vestib Res. 2004;14(6):467-78.
PMID: 15735329BACKGROUNDMcGibbon CA, Krebs DE, Parker SW, Scarborough DM, Wayne PM, Wolf SL. Tai Chi and vestibular rehabilitation improve vestibulopathic gait via different neuromuscular mechanisms: preliminary report. BMC Neurol. 2005 Feb 18;5(1):3. doi: 10.1186/1471-2377-5-3.
PMID: 15717934BACKGROUNDWayne PM, Manor B, Novak V, Costa MD, Hausdorff JM, Goldberger AL, Ahn AC, Yeh GY, Peng CK, Lough M, Davis RB, Quilty MT, Lipsitz LA. A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial. Contemp Clin Trials. 2013 Jan;34(1):21-34. doi: 10.1016/j.cct.2012.09.006. Epub 2012 Sep 29.
PMID: 23026349BACKGROUNDWayne PM, Kiel DP, Buring JE, Connors EM, Bonato P, Yeh GY, Cohen CJ, Mancinelli C, Davis RB. Impact of Tai Chi exercise on multiple fracture-related risk factors in post-menopausal osteopenic women: a pilot pragmatic, randomized trial. BMC Complement Altern Med. 2012 Jan 30;12:7. doi: 10.1186/1472-6882-12-7.
PMID: 22289280BACKGROUNDYeung A, Lepoutre V, Wayne P, Yeh G, Slipp LE, Fava M, Denninger JW, Benson H, Fricchione GL. Tai chi treatment for depression in Chinese Americans: a pilot study. Am J Phys Med Rehabil. 2012 Oct;91(10):863-70. doi: 10.1097/PHM.0b013e31825f1a67.
PMID: 22790795BACKGROUNDWayne PM, Gagnon MM, Macklin EA, Travison TG, Manor B, Lachman M, Thomas CP, Lipsitz LA. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing. Contemp Clin Trials. 2017 Sep;60:96-104. doi: 10.1016/j.cct.2017.07.005. Epub 2017 Jul 8.
PMID: 28694204BACKGROUNDCarlson LE, Zelinski EL, Speca M, Balneaves LG, Jones JM, Santa Mina D, Wayne PM, Campbell TS, Giese-Davis J, Faris P, Zwicker J, Patel K, Beattie TL, Cole S, Toivonen K, Nation J, Peng P, Thong B, Wong R, Vohra S. Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors. Contemp Clin Trials. 2017 Aug;59:64-76. doi: 10.1016/j.cct.2017.05.015. Epub 2017 May 30.
PMID: 28576734BACKGROUNDLengacher CA, Kip KE, Barta M, Post-White J, Jacobsen PB, Groer M, Lehman B, Moscoso MS, Kadel R, Le N, Loftus L, Stevens CA, Malafa MP, Shelton MM. A pilot study evaluating the effect of mindfulness-based stress reduction on psychological status, physical status, salivary cortisol, and interleukin-6 among advanced-stage cancer patients and their caregivers. J Holist Nurs. 2012 Sep;30(3):170-85. doi: 10.1177/0898010111435949. Epub 2012 Mar 21.
PMID: 22442202BACKGROUNDReich RR, Lengacher CA, Alinat CB, Kip KE, Paterson C, Ramesar S, Han HS, Ismail-Khan R, Johnson-Mallard V, Moscoso M, Budhrani-Shani P, Shivers S, Cox CE, Goodman M, Park J. Mindfulness-Based Stress Reduction in Post-treatment Breast Cancer Patients: Immediate and Sustained Effects Across Multiple Symptom Clusters. J Pain Symptom Manage. 2017 Jan;53(1):85-95. doi: 10.1016/j.jpainsymman.2016.08.005. Epub 2016 Oct 5.
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PMID: 12890093BACKGROUNDFischer M, Fugate-Woods N, Wayne PM. Use of pragmatic community-based interventions to enhance recruitment and adherence in a randomized trial of Tai Chi for women with osteopenia: insights from a qualitative substudy. Menopause. 2014 Nov;21(11):1181-9. doi: 10.1097/GME.0000000000000257.
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PMID: 20979675BACKGROUNDBudhrani-Shani P, Chau NG, Berry DL. Psychosocial distress and the preferred method of delivery of mind-body interventions among patients with head-and-neck cancer. Patient Relat Outcome Meas. 2018 Apr 3;9:129-136. doi: 10.2147/PROM.S149978. eCollection 2018.
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PMID: 33741070DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Pinky Budhrani-Shani, PhD, MSN, RN
University of Houston
- PRINCIPAL INVESTIGATOR
Peter Wayne, PhD
Brigham and Women's Hospital and Harvard Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
July 15, 2019
Study Start
April 22, 2019
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
December 30, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share