The Effect of Mindfulness Yoga on Sexual Functioning for Breast Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Change from sexual activity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Intervention group: mindfulness yoga
an 8-week structured mindfulness yoga program
Intervention: mindfulness yoga (Behavioral)
Waiting-list control group
provided the 8-week structured mindfulness yoga upon their completion of the study
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change from Quality of life (QOL)(4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention)
- Change from Fatigue(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(4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention)
- Change from Body Image(4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention)
- Change from Menopausal symptoms(4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention)
- Change from Sleep quality(4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention)
Investigators
Rui Yan
Doctor
The First Affiliated Hospital of Zhengzhou University