Caregiver DistressNCT04019301
Caring for Caregivers With Mind-body Exercise
A study testing Baduanjin Qigong, Community-based and Baduanjin Qigong, Internet-based in people with Caregiver Distress and Physical Function, run by University of Houston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Distress, Physical Function, Quality of Life
- What is being tested?
- Baduanjin Qigong, Community-based and Baduanjin Qigong, Internet-based
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Caregivers (CGs) often experience significant psychological and physical distress leading to marked reductions in caregivers' health and quality of life (QOL). Reducing CG distress has the potential to improve CG mental and physical health, improve overall QOL, and lead to improvements in the care they provide.
However, few effective interventions that can be widely delivered and easily adhered to have been rigorously evaluated. Qigong is an increasingly popular multi-modal mind-body exercise that shows promise in addressing a broad range of psychosocial and physical factors highly relevant to CGs. Sharing many characteristics with Tai Chi, Qigong incorporates elements of slow gentle movement, breath training, and number of cognitive skills including heightened body awareness, focused mental attention, and imagery-which collectively may afford greater benefits to health compared to unimodal therapies. A robust evidence base supports that Qigong and Tai Chi training in groups can improve multiple domains of physical and emotional health, QOL, and selfefficacy in diverse populations. Of note, recent national surveys indicate that a significant proportion of the US population that report using Qigong and Tai Chi for health preferred self-directed learning from DVDs and internet resources. While a handful of studies support the potential for web-based or DVD-based learning of mind-body practices, evaluations of such programs have not been well-tested, especially in CGs.
Using cancer caregivers (CCGs) as a representative population of the larger CG population, the longterm goal is to conduct a definitive trial evaluating a widely accessible and previously studied Qigong regimen (Eight Brocades, Baduanjin Qigong). Interventions will be delivered either in community-based groups led by instructors or via internet to individuals learning through recorded guided instruction supplemented with intermittent virtual live feedback from instructors. Outcomes will include QOL, fatigue, sleep disturbances, psychological distress, caregiver burden, and physical function. The short-term goals of this R34 are to conduct a mixed-methods pilot randomized controlled trial (RCT) to inform the feasibility and design of a definitive trial. The investigators will address these goals by randomizing (1:1:1) 54 CCGs to one of three conditions: (1) a community-based qigong program; (2) an internet-based qigong program; or (3) a self-care control group.
Specific Aim 1 is to finalize Qigong intervention content and delivery protocols. Specific Aim 2 will assess the 'learnability' of Qigong delivered in community-based group classes and via a web-based protocol using a novel proficiency instrument. Specific Aim 3 will evaluate the feasibility of recruiting and retaining CCGs into a 12-week clinical trial, and completing all outcomes testing protocols. Study feasibility and merit will be further informed by formal qualitative analysis of exit interviews of study completers, participants that withdraw, and Qigong instructors.
- Conditions
- Caregiver Distress, Physical Function, Quality of Life
- Being tested
- Baduanjin Qigong, Community-based, Baduanjin Qigong, Internet-based
- Keywords
- Cancer Caregiver, Qigong, Feasibility, Caregiver distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin Qigong, Community-basedOther
Also called Eight Brocades Regimen
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.
Baduanjin Qigong, Internet-basedOther
Also called Eight Brocades Regimen
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.
| Study group | Role | What they receive |
|---|---|---|
| Community-based Qigong Group | Experimental | Participants randomized into this group follow one, 75 minutes class per week supplemented by home practice for 20 minutes on 3 additional days. Receives: Other: Baduanjin Qigong, Community-based |
| Internet-based Qigong Group | Experimental | Participants randomized into this group follow two online sessions for 40 minutes each, also supplemented by home practice for 20 minutes on 3 additional days. Receives: Other: Baduanjin Qigong, Internet-based |
| Self-Care Control Group | No intervention | The 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility of recruited participants
Eligibility assessed by the % of eligible participants that are willing to consent to participate in the study.
Measured: 6 months
Adherence to Intervention
Intervention adherence assessed by the rate of compliance with classes and home practice.
Measured: 6 months
Secondary outcomes (11)
Center for Epidemiological Studies Depression Scale Revised (CESD-R-10)
Self-report measure of depression consisting of 10-items. Total score is calculated based on the sum of 10 items. Each item is scored 0 to 3 yielding a total between 0 and 30. Any score equal to or greater than 10 is considered depressed.
Measured: 6 months
Brief Fatigue Inventory (BFI)
Self-report measure of fatigue consisting of 9 items measuring the severity of fatigue and the impact of fatigue on daily functioning in the past 24 hours. Each item is scored 0-10 where 0 is no fatigue and 10 is bad fatigue, yielding a total between 0 and 90.
Measured: 6 months
Pittsburgh Sleep Quality Index (PSQI), Sleep Disturbances
Self-report measure of sleep disturbance consisting of 19 items measuring patients' sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping medication use, and daytime dysfunction over the past month. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed up to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: 6 months
Caregiver Burden Scale (CBS)
Self-report measure of caregiver burden consisting of 22 items measuring the impact of caregiving on three dimensions of burden: objective, subjective demand, and subjective stress. Each item is scored 0-4 (0=never; 4=nearly always), yielding a total between 0 and 88. Higher scores represent a worse outcome.
Measured: 6 months
Godin Leisure-Time Exercise Questionnaire, Physical Activity
Self-report measure of exercise consisting of 4 items measuring the frequency of light-intensity, moderate-intensity, and vigorous-intensity leisure-time physical activity. Each item is scored using units for strenuous exercise, moderate exercise, and mild exercise. Higher units represent a better outcome.
Measured: 6 months
Self-Efficacy Scale, Exercise Self-Efficacy
Self-report measure of self-efficacy consisting of 9 items measuring self-efficacy expectations related to the ability to continue exercising in the face of barriers to exercise. Each item is scored 0-10 (0 = not confident; 10 = very confident), yielding a total between 0 and 90. Higher values represent a better outcome.
Measured: 6 months
Cognitive Function, Test 1
Digit Span. Participants will be asked to repeat numbers in a specific order. Performance is indicated by the average number of digits correctly remembered.
Measured: 6 months
Cognitive Function, Test 2
Trail Making Test Parts A \& B. Participants are timed as they connect 25 circles without lifting the pen or pencil from the paper.
Measured: 6 months
Physical Function, Test 1
Grip strength: Strength of the dominant hand will be measured using a Jamar hydraulic hand dynamometer (Patterson Medical - Canada, Mississauga, ON, CAN).
Measured: 6 months
Physical Function, Test 2
Sit-to-stand. Participants will be asked to sit in a chair, cross their arms over their chest, and stand without the assistance of their arms. Number of times this is completed in 30 seconds will be recorded.
Measured: 6 months
Physical Function, Test 3
Balance. Participants will perform a static single-leg postural control balance test twice, once with eyes open and once with eyes closed. The maximum time for both will be limited to 30 seconds.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start22 Apr 2019
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (130)Papers the sponsor has linked to this study.
- Other trials for Caregiver DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cancer caregivers will be randomized to one of three conditions: (1) a community-based qigong program; (2) an internet-based qigong program; or (3) a self-care control group.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Texas Woman's University
- Responsible party
- Sponsor
- Investigators
- Pinky Budhrani-Shani, PhD, MSN, RN, Principal investigator, University of HoustonPeter Wayne, PhD, Principal investigator, Brigham and Women's Hospital and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019301
- Sponsor's protocol ID
- R34AT010081
- Status last verified
- Dec 2021
- First submitted
- 21 Jun 2019
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Alliance for Caregiving and AARP. Caregiving in the U.S. 2015. 2015; Available from: http://www.aarp.org/content/dam/aarp/ppi/2015/caregiving-in-the-united-states-2015-report-revised.pdf.
Lambert SD, Harrison JD, Smith E, Bonevski B, Carey M, Lawsin C, Paul C, Girgis A. The unmet needs of partners and caregivers of adults diagnosed with cancer: a systematic review. BMJ Support Palliat Care. 2012 Sep;2(3):224-30. doi: 10.1136/bmjspcare-2012-000226. Epub 2012 Jul 7.
PubMed 24654195Merckaert I, Libert Y, Lieutenant F, Moucheux A, Farvacques C, Slachmuylder JL, Razavi D. Desire for formal psychological support among caregivers of patients with cancer: prevalence and implications for screening their needs. Psychooncology. 2013 Jun;22(6):1389-95. doi: 10.1002/pon.3153. Epub 2012 Aug 8.
PubMed 22888079Braun M, Mikulincer M, Rydall A, Walsh A, Rodin G. Hidden morbidity in cancer: spouse caregivers. J Clin Oncol. 2007 Oct 20;25(30):4829-34. doi: 10.1200/JCO.2006.10.0909.
PubMed 17947732Kim Y, Kashy DA, Spillers RL, Evans TV. Needs assessment of family caregivers of cancer survivors: three cohorts comparison. Psychooncology. 2010 Jun;19(6):573-82. doi: 10.1002/pon.1597.
PubMed 19582798Rabin EG, Heldt E, Hirakata VN, Bittelbrunn AC, Chachamovich E, Fleck MP. Depression and perceptions of quality of life of breast cancer survivors and their male partners. Oncol Nurs Forum. 2009 May;36(3):E153-8. doi: 10.1188/09.ONF.E153-E158.
PubMed 19403443Ploeg J, Markle-Reid M, Valaitis R, McAiney C, Duggleby W, Bartholomew A, Sherifali D. Web-Based Interventions to Improve Mental Health, General Caregiving Outcomes, and General Health for Informal Caregivers of Adults With Chronic Conditions Living in the Community: Rapid Evidence Review. J Med Internet Res. 2017 Jul 28;19(7):e263. doi: 10.2196/jmir.7564.
PubMed 28754652Lengacher CA, Reich RR, Paterson CL, Ramesar S, Park JY, Alinat C, Johnson-Mallard V, Moscoso M, Budhrani-Shani P, Miladinovic B, Jacobsen PB, Cox CE, Goodman M, Kip KE. Examination of Broad Symptom Improvement Resulting From Mindfulness-Based Stress Reduction in Breast Cancer Survivors: A Randomized Controlled Trial. J Clin Oncol. 2016 Aug 20;34(24):2827-34. doi: 10.1200/JCO.2015.65.7874. Epub 2016 May 31.
PubMed 27247219Leung L, Han H, Martin M, Kotecha J. Mindfulness-based stress reduction (MBSR) as sole intervention for non-somatisation chronic non-cancer pain (CNCP): protocol for a systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2015 May 18;5(5):e007650. doi: 10.1136/bmjopen-2015-007650.
PubMed 25986638Zeng Y, Luo T, Xie H, Huang M, Cheng AS. Health benefits of qigong or tai chi for cancer patients: a systematic review and meta-analyses. Complement Ther Med. 2014 Feb;22(1):173-86. doi: 10.1016/j.ctim.2013.11.010. Epub 2013 Dec 18.
PubMed 24559833Bajaj JS, Ellwood M, Ainger T, Burroughs T, Fagan A, Gavis EA, Heuman DM, Fuchs M, John B, Wade JB. Mindfulness-Based Stress Reduction Therapy Improves Patient and Caregiver-Reported Outcomes in Cirrhosis. Clin Transl Gastroenterol. 2017 Jul 27;8(7):e108. doi: 10.1038/ctg.2017.38.
PubMed 28749453Stjernsward S, Hansson L. Effectiveness and Usability of a Web-Based Mindfulness Intervention for Families Living with Mental Illness. Mindfulness (N Y). 2017;8(3):751-764. doi: 10.1007/s12671-016-0653-2. Epub 2016 Dec 8.
PubMed 28515801Milbury K, Chaoul A, Engle R, Liao Z, Yang C, Carmack C, Shannon V, Spelman A, Wangyal T, Cohen L. Couple-based Tibetan yoga program for lung cancer patients and their caregivers. Psychooncology. 2015 Jan;24(1):117-20. doi: 10.1002/pon.3588. Epub 2014 May 29. No abstract available.
PubMed 24890852Milbury K, Mallaiah S, Mahajan A, Armstrong T, Weathers SP, Moss KE, Goktepe N, Spelman A, Cohen L. Yoga Program for High-Grade Glioma Patients Undergoing Radiotherapy and Their Family Caregivers. Integr Cancer Ther. 2018 Jun;17(2):332-336. doi: 10.1177/1534735417689882. Epub 2017 Feb 2.
PubMed 28150503Kotronoulas G, Wengstrom Y, Kearney N. Alterations and Interdependence in Self-Reported Sleep-Wake Parameters of Patient-Caregiver Dyads During Adjuvant Chemotherapy for Breast Cancer . Oncol Nurs Forum. 2016 May 1;43(3):288-301. doi: 10.1188/16.ONF.288-301.
PubMed 27105191
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Caregivers With Mind-body Exercise
- ClinicalTrials.gov ID
- NCT04019301
- Acronym / sponsor ID
- R34AT010081
- Conditions
- Caregiver Distress, Physical Function, Quality of Life
- Keywords
- Cancer Caregiver, Qigong, Feasibility, Caregiver distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Texas Woman's University
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Caregivers (CGs) often experience significant psychological and physical distress leading to marked reductions in caregivers' health and quality of life (QOL). Reducing CG distress has the potential to improve CG mental and physical health, improve overall QOL, and lead to improvements in the care they provide.
However, few effective interventions that can be widely delivered and easily adhered to have been rigorously evaluated. Qigong is an increasingly popular multi-modal mind-body exercise that shows promise in addressing a broad range of psychosocial and physical factors highly relevant to CGs. Sharing many characteristics with Tai Chi, Qigong incorporates elements of slow gentle movement, breath training, and number of cognitive skills including heightened body awareness, focused mental attention, and imagery-which collectively may afford greater benefits to health compared to unimodal therapies. A robust evidence base supports that Qigong and Tai Chi training in groups can improve multiple domains of physical and emotional health, QOL, and selfefficacy in diverse populations. Of note, recent national surveys indicate that a significant proportion of the US population that report using Qigong and Tai Chi for health preferred self-directed learning from DVDs and internet resources. While a handful of studies support the potential for web-based or DVD-based learning of mind-body practices, evaluations of such programs have not been well-tested, especially in CGs.
Using cancer caregivers (CCGs) as a representative population of the larger CG population, the longterm goal is to conduct a definitive trial evaluating a widely accessible and previously studied Qigong regimen (Eight Brocades, Baduanjin Qigong). Interventions will be delivered either in community-based groups led by instructors or via internet to individuals learning through recorded guided instruction supplemented with intermittent virtual live feedback from instructors. Outcomes will include QOL, fatigue, sleep disturbances, psychological distress, caregiver burden, and physical function. The short-term goals of this R34 are to conduct a mixed-methods pilot randomized controlled trial (RCT) to inform the feasibility and design of a definitive trial. The investigators will address these goals by randomizing (1:1:1) 54 CCGs to one of three conditions: (1) a community-based qigong program; (2) an internet-based qigong program; or (3) a self-care control group.
Specific Aim 1 is to finalize Qigong intervention content and delivery protocols. Specific Aim 2 will assess the 'learnability' of Qigong delivered in community-based group classes and via a web-based protocol using a novel proficiency instrument. Specific Aim 3 will evaluate the feasibility of recruiting and retaining CCGs into a 12-week clinical trial, and completing all outcomes testing protocols. Study feasibility and merit will be further informed by formal qualitative analysis of exit interviews of study completers, participants that withdraw, and Qigong instructors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cancer caregivers will be randomized to one of three conditions: (1) a community-based qigong program; (2) an internet-based qigong program; or (3) a self-care control group.
| Arm | Type | Receives |
|---|---|---|
| Community-based Qigong Group | Experimental | Other: Baduanjin Qigong, Community-basedParticipants 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 | Experimental | Other: Baduanjin Qigong, Internet-basedParticipants 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 intervention | –The 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin Qigong, Community-basedAlso: Eight Brocades RegimenThe 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. | Other | Community-based Qigong Group |
| Baduanjin Qigong, Internet-basedAlso: Eight Brocades RegimenThe 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. | Other | Internet-based Qigong Group |
Primary outcome
Eligibility of recruited participants
Time frame: 6 months
Eligibility assessed by the % of eligible participants that are willing to consent to participate in the study.
Adherence to Intervention
Time frame: 6 months
Intervention adherence assessed by the rate of compliance with classes and home practice.
11 secondary outcomes
Center for Epidemiological Studies Depression Scale Revised (CESD-R-10)
Time frame: 6 months
Brief Fatigue Inventory (BFI)
Time frame: 6 months
Pittsburgh Sleep Quality Index (PSQI), Sleep Disturbances
Time frame: 6 months
Caregiver Burden Scale (CBS)
Time frame: 6 months
Godin Leisure-Time Exercise Questionnaire, Physical Activity
Time frame: 6 months
Self-Efficacy Scale, Exercise Self-Efficacy
Time frame: 6 months
Cognitive Function, Test 1
Time frame: 6 months
Cognitive Function, Test 2
Time frame: 6 months
Physical Function, Test 1
Time frame: 6 months
Physical Function, Test 2
Time frame: 6 months
Physical Function, Test 3
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- BackgroundNational Alliance for Caregiving and AARP. Caregiving in the U.S. 2015. 2015; Available from: http://www.aarp.org/content/dam/aarp/ppi/2015/caregiving-in-the-united-states-2015-report-revised.pdf.
- Background: PubMed 24654195Lambert SD, Harrison JD, Smith E, Bonevski B, Carey M, Lawsin C, Paul C, Girgis A. The unmet needs of partners and caregivers of adults diagnosed with cancer: a systematic review. BMJ Support Palliat Care. 2012 Sep;2(3):224-30. doi: 10.1136/bmjspcare-2012-000226. Epub 2012 Jul 7.
- Background: PubMed 22888079Merckaert I, Libert Y, Lieutenant F, Moucheux A, Farvacques C, Slachmuylder JL, Razavi D. Desire for formal psychological support among caregivers of patients with cancer: prevalence and implications for screening their needs. Psychooncology. 2013 Jun;22(6):1389-95. doi: 10.1002/pon.3153. Epub 2012 Aug 8.
- Background: PubMed 17947732Braun M, Mikulincer M, Rydall A, Walsh A, Rodin G. Hidden morbidity in cancer: spouse caregivers. J Clin Oncol. 2007 Oct 20;25(30):4829-34. doi: 10.1200/JCO.2006.10.0909.
- Background: PubMed 19582798Kim Y, Kashy DA, Spillers RL, Evans TV. Needs assessment of family caregivers of cancer survivors: three cohorts comparison. Psychooncology. 2010 Jun;19(6):573-82. doi: 10.1002/pon.1597.
- Background: PubMed 19403443Rabin EG, Heldt E, Hirakata VN, Bittelbrunn AC, Chachamovich E, Fleck MP. Depression and perceptions of quality of life of breast cancer survivors and their male partners. Oncol Nurs Forum. 2009 May;36(3):E153-8. doi: 10.1188/09.ONF.E153-E158.
- Background: PubMed 28754652Ploeg J, Markle-Reid M, Valaitis R, McAiney C, Duggleby W, Bartholomew A, Sherifali D. Web-Based Interventions to Improve Mental Health, General Caregiving Outcomes, and General Health for Informal Caregivers of Adults With Chronic Conditions Living in the Community: Rapid Evidence Review. J Med Internet Res. 2017 Jul 28;19(7):e263. doi: 10.2196/jmir.7564.
- Background: PubMed 27247219Lengacher CA, Reich RR, Paterson CL, Ramesar S, Park JY, Alinat C, Johnson-Mallard V, Moscoso M, Budhrani-Shani P, Miladinovic B, Jacobsen PB, Cox CE, Goodman M, Kip KE. Examination of Broad Symptom Improvement Resulting From Mindfulness-Based Stress Reduction in Breast Cancer Survivors: A Randomized Controlled Trial. J Clin Oncol. 2016 Aug 20;34(24):2827-34. doi: 10.1200/JCO.2015.65.7874. Epub 2016 May 31.
- Background: PubMed 25986638Leung L, Han H, Martin M, Kotecha J. Mindfulness-based stress reduction (MBSR) as sole intervention for non-somatisation chronic non-cancer pain (CNCP): protocol for a systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2015 May 18;5(5):e007650. doi: 10.1136/bmjopen-2015-007650.
- Background: PubMed 24559833Zeng Y, Luo T, Xie H, Huang M, Cheng AS. Health benefits of qigong or tai chi for cancer patients: a systematic review and meta-analyses. Complement Ther Med. 2014 Feb;22(1):173-86. doi: 10.1016/j.ctim.2013.11.010. Epub 2013 Dec 18.
- Background: PubMed 28749453Bajaj JS, Ellwood M, Ainger T, Burroughs T, Fagan A, Gavis EA, Heuman DM, Fuchs M, John B, Wade JB. Mindfulness-Based Stress Reduction Therapy Improves Patient and Caregiver-Reported Outcomes in Cirrhosis. Clin Transl Gastroenterol. 2017 Jul 27;8(7):e108. doi: 10.1038/ctg.2017.38.
- Background: PubMed 28515801Stjernsward S, Hansson L. Effectiveness and Usability of a Web-Based Mindfulness Intervention for Families Living with Mental Illness. Mindfulness (N Y). 2017;8(3):751-764. doi: 10.1007/s12671-016-0653-2. Epub 2016 Dec 8.
- Individual participant dataSharing planned: No
Related trials for Caregiver Distress
RecruitingPhase 4
A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)
Alzheimer Disease
Recruiting
Project EMPOWER-OCD
Obsessive-Compulsive Disorder
RecruitingPhase 2
The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project
Breast Cancer Female, Psychological Distress
Recruiting
Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest
Emotional Distress, Cardiac Arrest (CA)
Recruiting
ACT for Dementia Caregivers: Evaluating Psychological Flexibility as the Mechanism to Improve Psychological Distress
Dementia Caregivers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinky Budhrani-Shani, PhD, MSN, RN principal investigator
University of Houston
Peter Wayne, PhD principal investigator
Brigham and Women's Hospital and Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin Qigong, Community-based and Baduanjin Qigong, Internet-based in people with Caregiver Distress and Physical Function, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility of recruited participants (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019301, which also lists 130 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.