Breast CancerNCT05461534
Mindfulness Yoga and Sexual Functioning
A study testing mindfulness yoga in people with Breast Cancer and Sexual Dysfunction, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Female breast cancer survivors with sexual dysfunction were randomly divided into a mindfulness yoga intervention group and a control group, and the investigators aimed to evaluate the effects of mindfulness yoga on sexual function in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Sexual Dysfunction
- What is being tested?
- mindfulness yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Aug 2024
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years; diagnosed with primary breast cancer (stages:T1-T4, N0-N1, M0); individuals who have completed surgery, chemotherapy and radiotherapy (with the exception of immunotherapy and endocrine therapy); without cognitive impairment; diagnosed with sexual dysfunction.
Who cannot join
- without sexual experience; in pregnancy or lactation; individuals with serious cognitive or psychiatric issues (i.e., depression, alcohol dependency, or psychotic disorders); individuals who are illiterate, with hearing disorder or communication difficulties; individuals with other type of tumors or other serious acute or chronic diseases at the time of enrollment; individuals participate in a concurrent medical treatment or nonmedical treatment targeting sexual problems; individuals participate in a concurrent psychotherapy; individuals with experience in mindfulness or yoga.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
Rui Yan, Doctor, +8613592609301, dryanrui@163.com
About this study
Official title: The Effect of Mindfulness Yoga on Sexual Functioning for Breast Cancer Survivors
Female breast cancer survivors with sexual dysfunction were randomly divided into a mindfulness yoga intervention group and a control group, and the investigators aimed to evaluate the effects of mindfulness yoga on sexual function in breast cancer survivors.
- Conditions
- Breast Cancer, Sexual Dysfunction
- Being tested
- mindfulness yoga
- Medical subject headings
- Breast Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness yogaBehavioural
Each mindfulness yoga session will last for 90 minutes and will be conducted in a group format once a week. Each session includes breathing exercise (10 min), mindfulness meditation and body scan (20 min) and yoga practice (60 min).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: mindfulness yoga | Experimental | an 8-week structured mindfulness yoga program Receives: Behavioral: mindfulness yoga |
| Waiting-list control group | No intervention | provided the 8-week structured mindfulness yoga upon their completion of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from sexual activity
The score change of the Sexual Activity Questionnaire(SAQ).The SAQ consists of 10 items and three subscales. Higher pleasure or discomfort subscale score indicated higher levels of pleasure or discomfort, and habit is a single item (0 'less sexual activity than usual' to 3 'much more sexual activity than usual').
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Female sexual function index
The score change of Female Sexual Function Index (FSFI). FSFI consists of 19 items comprising six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain). The total score ranges from 0 to 36. Higher score corresponds to better sexual functioning.
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Sexual distress
The change of The Female Sexual Distress Scale-Revised (FSDS-R).The total score ranges from 0 to 48, and a higher score indicates a higher level of sexual distress.
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Secondary outcomes (6)
Change from Body Image
Body Image Subscale (BIS) of the European Organization for Research and Treatment of Cancer Quality of Life-Breast Cancer Module (EORTC- QLQ-BR23) will be used. The total score ranges from 4 to 16, and higher score indicates higher level of body image.
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Anxiety and Depression
The Hospital Anxiety and Depression Scale (HADS) will be used.Higher HADS-D ( ranges from 0-21) or HADS-A ( ranges from 0-21) score correspond to more serious psychological distress
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Menopausal symptoms
The Endocrine symptom subscale (ESS) of the Endocrine Subscale for The Functional Assessment of Cancer Therapy-Breast (FACT-B ES) will be used. The total score ranges from 0 to 72. Higher score indicates fewer menopausal symptoms
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Fatigue
The Brief Fatigue Inventory (BFI) will be used. The total score ranges from 0 to 90. Higher scores on the BFI indicates greater self-reported levels of fatigue.
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) will be used. The total score ranges from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Quality of life (QOL)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) simplified Chinese V3.0 version will be used. The total score ranges from 0 to 100. Higher scores of symptom and financial scales indicates more severe symptoms.
Measured: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Yan, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461534
- Sponsor's protocol ID
- CTR20220630
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.
PubMed 40421669
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Yoga on Sexual Functioning for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05461534
- Acronym / sponsor ID
- CTR20220630
- Conditions
- Breast Cancer, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 18 Jul 2022 (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.
Female breast cancer survivors with sexual dysfunction were randomly divided into a mindfulness yoga intervention group and a control group, and the investigators aimed to evaluate the effects of mindfulness yoga on sexual function in breast cancer survivors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: mindfulness yoga | Experimental | Behavioral: mindfulness yogaan 8-week structured mindfulness yoga program |
| Waiting-list control group | No intervention | –provided the 8-week structured mindfulness yoga upon their completion of the study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 18-65 years; diagnosed with primary breast cancer (stages:T1-T4, N0-N1, M0); individuals who have completed surgery, chemotherapy and radiotherapy (with the exception of immunotherapy and endocrine therapy); without cognitive impairment; diagnosed with sexual dysfunction.
Key exclusion criteria (1 listed)
- without sexual experience; in pregnancy or lactation; individuals with serious cognitive or psychiatric issues (i.e., depression, alcohol dependency, or psychotic disorders); individuals who are illiterate, with hearing disorder or communication difficulties; individuals with other type of tumors or other serious acute or chronic diseases at the time of enrollment; individuals participate in a concurrent medical treatment or nonmedical treatment targeting sexual problems; individuals participate in a concurrent psychotherapy; individuals with experience in mindfulness or yoga.
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 |
|---|---|---|
| mindfulness yogaEach mindfulness yoga session will last for 90 minutes and will be conducted in a group format once a week. Each session includes breathing exercise (10 min), mindfulness meditation and body scan (20 min) and yoga practice (60 min). | Behavioural | Intervention group: mindfulness yoga |
Primary outcome
Change from sexual activity
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The score change of the Sexual Activity Questionnaire(SAQ).The SAQ consists of 10 items and three subscales. Higher pleasure or discomfort subscale score indicated higher levels of pleasure or discomfort, and habit is a single item (0 'less sexual activity than usual' to 3 'much more sexual activity than usual').
Change from Female sexual function index
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The score change of Female Sexual Function Index (FSFI). FSFI consists of 19 items comprising six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain). The total score ranges from 0 to 36. Higher score corresponds to better sexual functioning.
Change from Sexual distress
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The change of The Female Sexual Distress Scale-Revised (FSDS-R).The total score ranges from 0 to 48, and a higher score indicates a higher level of sexual distress.
6 secondary outcomes
Change from Body Image
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Anxiety and Depression
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Menopausal symptoms
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Fatigue
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Sleep quality
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Quality of life (QOL)
Time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 40421669Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness yoga in people with Breast Cancer and Sexual Dysfunction, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 18 Jul 2022. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from sexual activity (time frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention). The study lists 3 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 NCT05461534, which also lists 1 linked publication.
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 18 Jul 2022.