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Breast Cancer SurvivorsNCT05793710

Effects o Laughing Qigong Program on Psychological Outcomes and the Physiological Immunological Responses

A study testing The principle of laughter plus Qigong in people with Breast Cancer Survivors, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Laughter programs are safe, affordable, and age-appropriate activities. Few studies have utilized mixed study designs to look at the impact on resilience in and experiences of participants in such activities. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Survivors
What is being tested?
The principle of laughter plus Qigong
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteTaiwan
Study dates
30 Dec 2013to 29 Dec 2014
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) female adult (18 years old); 2) diagnosed with stage I-III breast cancer; 3) major treatment completed at least 3 months ago (i.e. surgery, chemotherapy, and/or radiotherapy); and 4) no communication difficulties (visual and auditory).

Who cannot join

  • 1) having recurrent or metastatic breast cancer; 2) being involved in other studies at the same time, 3) patients who are unable to cooperate with the trial and follow-up; and 4) having a history of mental illness in past 3 months (major depression disorder)..

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taipei University of Nursing and Health Sciences

    Taipei, 112303

Other trials in Taiwan

About this study

Official title: Effects of a 12-week Laughing Qigong Program on Psychological Outcomes and the Physiological Immunological Responses Among Female Breast Cancer Survivors: A Quasi-experimental Nonequivalent Control Group

Laughter programs are safe, affordable, and age-appropriate activities. Few studies have utilized mixed study designs to look at the impact on resilience in and experiences of participants in such activities.

Read the detailed description

The laughing qigong program is a physical and mental practice program that combines qigong and laughter. It is influenced by Chinese local culture. It emphasizes the transformation of voice, body, and emotional use so that people can experience relaxation and tranquility, and then the transformation of emotions so that physical and mental energy can be released then to achieve balance. Our research has shown that laughter-related psychological interventions have consistent effects on mental health, reducing mood conditions under life stress (Grace, 2013), depressed mood (Hsieh et al., 2015), and cortisol concentration (Grace, 2013). However, there have only been a few studies where similar protocols focused on positive mental states (e.g. resilience, well-being) and the application of laughing in immune function.

Therefore, the current quasi-experimental trial was to investigate the effects of the LQP on psychological outcomes (resilience and well-being), mucosal immunity (salivary immunoglobulin A, s-IgA), and immune-inflammatory index (interleukins, IL-6) amongst breast cancer survivors. We hypothesized that (a) experimental group participants would have significantly higher levels of resilience and well-being at baseline (before the test) and post-treatment (post-test) compared to the wait list control group; (b) Compared to the control group on the wait list, experimental group participants will have significant differences in mucosal immunity (s-IgA) and inflammatory index (IL-6) before and after the test; and (c) experimental group membership had a significant effect on psychological outcomes (resilience and well-being) as well as mucosal immunity (s-IgA) and immune-inflammatory indices (IL-6) after a 12-week LQP intervention

Being tested
The principle of laughter plus Qigong
Keywords
Laughing Qigong Program, well-being, salivary biomarkers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The principle of laughter plus QigongBehavioural

    The intervention program include muscle stretching, breathing exercises, and closing exercises. The laughing practice method begins with a warm-up consisting of laughing to stretch the body, yawning, and exerting the voice, and ends with expelling all the "qi" in order to return to natural movements and return to taking care of your body and mind (He et al., 2021).

    The LQP program meets once a week for 90 minutes and runs for 12 weeks. The program content: the laughter skills were 50-60 minutes, the feedback was 30 minutes, and relaxation was 10 minutes.

Study groups in NCT05793710
Study groupRoleWhat they receive
the principle of laughter plus QigongExperimentalThe basic method of " LQP " is the principle of laughter plus Qigong, combined with the sound of laughter, stretching the body, thereby activating the parasympathetic nerve, so that the body can automatically relax, and at the same time guide the individual to face their own emotions when facing pressure, and transform emotions into positive energy or relieve negative emotions through practice, so as to achieve the energy balance of body, mind and spirit.
Receives: Behavioral: The principle of laughter plus Qigong
their current lifestyle for a 12-weekNo interventionAfter baseline testing, participants in the waitlist control group (CON) were asked to maintain their current lifestyle for a 12-week. Participants in the CON group will then undergo a 12-week fully supervised intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resilience scale

    This scale is used to assess an individual's resilience to setbacks. There is a total of 25 items. For each item, the Likert five-point scale is used, with scores ranging from 1 (extremely dissatisfied) to 5 (extremely satisfied) (very satisfied). The higher the score, the more resilient to frustration. The scale was divided into five items, the higher the score, which are a meaningful life, a peaceful mind, self-confidence, an indomitable spirit, and acceptance of the loneliness of existence (Wagnild, \& Young, 1993).The psychometric evaluation of this scale supports its internal consistency reliability and concurrent validity as a good tool for measuring resilience (Wagnild, \& Young, 1993), and the scale has also been translated into Chinese and demonstrates good reliability (α=0.91) and validity.

    Measured: Pre-intervention(T0)]

  2. Pre-intervention(T0)]

    The Thai Mental Health Indicator (TMHI) Scale was used to assess one's mental health, the indicator has 15 items divided into four categories: mental state, mental capacity, mental equality, and social support (Mongkol, Tangseree, Udomratn, Huttapanom, \& Chuta, 2007; Songprakun and McCann 2012). Each item is scored on a scale of 0 (never) to 3, with a total score of 45 points indicating better well-being outcomes. The scale has good reliability and construct validity (Mongkol, Tangseree, Udomratn, Huttapanom, \& Chuta, 2007), and it was used by two-way translation and showed excellent reliability (0.90) in this study. This scale is used after the second stage translation was completed and confirming when the sentences be smooth and the meaning

    Measured: Pre-intervention(T0)]

  3. Resilience Scale

    This scale is used to assess an individual's resilience to setbacks. There is a total of 25 items. For each item, the Likert five-point scale is used, with scores ranging from 1 (extremely dissatisfied) to 5 (extremely satisfied) (very satisfied). The higher the score, the more resilient to frustration. The scale was divided into five items, the higher the score, which are a meaningful life, a peaceful mind, self-confidence, an indomitable spirit, and acceptance of the loneliness of existence (Wagnild, \& Young, 1993).The psychometric evaluation of this scale supports its internal consistency reliability and concurrent validity as a good tool for measuring resilience (Wagnild, \& Young, 1993), and the scale has also been translated into Chinese and demonstrates good reliability (α=0.91) and validity

    Measured: 5-week after intervention (T1)]

  4. Resilience Scale

    This scale is used to assess an individual's resilience to setbacks. There is a total of 25 items. For each item, the Likert five-point scale is used, with scores ranging from 1 (extremely dissatisfied) to 5 (extremely satisfied) (very satisfied). The higher the score, the more resilient to frustration. The scale was divided into five items, the higher the score, which are a meaningful life, a peaceful mind, self-confidence, an indomitable spirit, and acceptance of the loneliness of existence (Wagnild, \& Young, 1993).The psychometric evaluation of this scale supports its internal consistency reliability and concurrent validity as a good tool for measuring resilience (Wagnild, \& Young, 1993), and the scale has also been translated into Chinese and demonstrates good reliability (α=0.91) and validity

    Measured: 12-week after intervention (T2)]

  5. Thai Mental Health Indicator (TMHI)

    The Thai Mental Health Indicator (TMHI) Scale was used to assess one's mental health, the indicator has 15 items divided into four categories: mental state, mental capacity, mental equality, and social support (Mongkol, Tangseree, Udomratn, Huttapanom, \& Chuta, 2007; Songprakun and McCann 2012). Each item is scored on a scale of 0 (never) to 3, with a total score of 45 points indicating better well-being outcomes. The scale has good reliability and construct validity (Mongkol, Tangseree, Udomratn, Huttapanom, \& Chuta, 2007), and it was used by two-way translation and showed excellent reliability (0.90) in this study. This scale is used after the second stage translation was completed and confirming when the sentences be smooth and the meaning.

    Measured: 5-week after intervention (T1)]

  6. Thai Mental Health Indicator (TMHI)

    The Thai Mental Health Indicator (TMHI) Scale was used to assess one's mental health, the indicator has 15 items divided into four categories: mental state, mental capacity, mental equality, and social support (Mongkol, Tangseree, Udomratn, Huttapanom, \& Chuta, 2007; Songprakun and McCann 2012). Each item is scored on a scale of 0 (never) to 3, with a total score of 45 points indicating better well-being outcomes. The scale has good reliability and construct validity (Mongkol, Tangseree, Udomratn, Huttapanom, \& Chuta, 2007), and it was used by two-way translation and showed excellent reliability (0.90) in this study. This scale is used after the second stage translation was completed and confirming when the sentences be smooth and the meaning.

    Measured: 12-week after intervention (T2)]

Secondary outcomes (6)

  1. Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

    The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant.

    Measured: Pre-intervention(T0)]

  2. Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

    The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant.

    Measured: 5-week after intervention (T1)]

  3. Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

    The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant.

    Measured: 12-week after intervention (T2)]

  4. Saliva Interleukin-6 (IL-6

    The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA)

    Measured: Pre-intervention(T0)]

  5. Saliva Interleukin-6 (IL-6

    The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA)

    Measured: 5-week after intervention (T1)]

  6. Saliva Interleukin-6 (IL-6

    The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA)

    Measured: 12-week after intervention (T2)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2023
  2. Study start30 Dec 2013
  3. Primary completion29 Dec 2014
  4. Study completion29 Dec 2014

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05793710
Sponsor's protocol ID
IRB-201311HM023
Status last verified
Mar 2023
First submitted
20 Mar 2023
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luo C, Li N, Lu B, Cai J, Lu M, Zhang Y, Chen H, Dai M. Global and regional trends in incidence and mortality of female breast cancer and associated factors at national level in 2000 to 2019. Chin Med J (Engl). 2022 Jan 5;135(1):42-51. doi: 10.1097/CM9.0000000000001814.

    PubMed 34593698

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Carreira H, Williams R, Funston G, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: A matched population-based cohort study in the United Kingdom. PLoS Med. 2021 Jan 7;18(1):e1003504. doi: 10.1371/journal.pmed.1003504. eCollection 2021 Jan.

    PubMed 33411711

  • Rottmann N, Dalton SO, Christensen J, Frederiksen K, Johansen C. Self-efficacy, adjustment style and well-being in breast cancer patients: a longitudinal study. Qual Life Res. 2010 Aug;19(6):827-36. doi: 10.1007/s11136-010-9653-1. Epub 2010 Apr 17.

    PubMed 20401551

  • Borgi M, Collacchi B, Ortona E, Cirulli F. Stress and coping in women with breast cancer:unravelling the mechanisms to improve resilience. Neurosci Biobehav Rev. 2020 Dec;119:406-421. doi: 10.1016/j.neubiorev.2020.10.011. Epub 2020 Oct 18.

    PubMed 33086128

  • Eicher M, Ribi K, Senn-Dubey C, Senn S, Ballabeni P, Betticher D. Interprofessional, psycho-social intervention to facilitate resilience and reduce supportive care needs for patients with cancer: Results of a noncomparative, randomized phase II trial. Psychooncology. 2018 Jul;27(7):1833-1839. doi: 10.1002/pon.4734. Epub 2018 May 4.

    PubMed 29655277

  • Aizpurua-Perez I, Perez-Tejada J. Resilience in women with breast cancer: A systematic review. Eur J Oncol Nurs. 2020 Dec;49:101854. doi: 10.1016/j.ejon.2020.101854. Epub 2020 Oct 10.

    PubMed 33120216

  • 8. Azhari, R., & Harkomah, I. (2021). Progressive muscle relaxation, spiritual guided imagery, music on coping and resilience among cancer patients who undergo chemotherapy. KnE Life Sciences, 344-355.

  • Plitzko L, Mehnert-Theuerkauf A, Gotze H. [Resilience in Long-Term Cancer Survivors - Associations with Psychological Distress and Sociodemographic Characteristics]. Psychother Psychosom Med Psychol. 2020 May;70(5):182-189. doi: 10.1055/a-0927-6782. Epub 2019 Jul 17. German.

    PubMed 31315142

  • Van Puymbroeck M, Burk BN, Shinew KJ, Cronan Kuhlenschmidt M, Schmid AA. Perceived health benefits from yoga among breast cancer survivors. Am J Health Promot. 2013 May-Jun;27(5):308-15. doi: 10.4278/ajhp.110316-QUAL-119. Epub 2013 Feb 12.

    PubMed 23402226

  • Loprinzi CE, Prasad K, Schroeder DR, Sood A. Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Clin Breast Cancer. 2011 Dec;11(6):364-8. doi: 10.1016/j.clbc.2011.06.008. Epub 2011 Aug 10.

    PubMed 21831722

  • Wang HH, Chung UL. Use of complementary and alternative medicine among breast cancer survivors in Taiwan. Asian Pac J Cancer Prev. 2012;13(9):4789-92. doi: 10.7314/apjcp.2012.13.9.4789.

    PubMed 23167421

  • Correa-Velez I, Clavarino A, Barnett AG, Eastwood H. Use of complementary and alternative medicine and quality of life: changes at the end of life. Palliat Med. 2003 Dec;17(8):695-703. doi: 10.1191/0269216303pm834oa.

    PubMed 14694921

  • McEwen BS. The neurobiology of stress: from serendipity to clinical relevance. Brain Res. 2000 Dec 15;886(1-2):172-189. doi: 10.1016/s0006-8993(00)02950-4.

    PubMed 11119695

  • McEwen BS. Physiology and neurobiology of stress and adaptation: central role of the brain. Physiol Rev. 2007 Jul;87(3):873-904. doi: 10.1152/physrev.00041.2006.

    PubMed 17615391

Questions about this trial

What is this clinical trial studying?

A study testing The principle of laughter plus Qigong in people with Breast Cancer Survivors, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Mar 2023. 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 Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Resilience scale (time frame: Pre-intervention(T0)]). The study lists 6 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 NCT05793710, which also lists 20 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 31 Mar 2023.

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