Mindfulness Yoga and Sexual Functioning

Not Applicable

• Conditions: Sexual Dysfunction; Breast Cancer
• Interventions: Behavioral: mindfulness yoga

• Registration Number: NCT05461534
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-30
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-13
• Last Update Submitted: 2022-07-13
• Study First Posted: 2022-07-18
• Last Update Posted: 2022-07-18
• Study Start: 2022-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: mindfulness yoga	mindfulness yoga	an 8-week structured mindfulness yoga program

Primary Outcome Measures

Name	Time	Method
Change from sexual activity	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	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	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 Outcome Measures

Name	Time	Method
Change from Fatigue	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention	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.
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	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
Change from Body Image	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention	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.
Change from Menopausal symptoms	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention	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
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	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.
Change from Sleep quality	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention	The Pittsburgh Sleep Quality Index (PSQI) will be used. The total score ranges from 0 to 21. Higher scores indicate poorer sleep quality.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China