Mindfulness Yoga and Sexual Functioning

Breast Cancer Clinical Trial

Official title:

The Effect of Mindfulness Yoga on Sexual Functioning for Breast Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05461534
• Other study ID #: CTR20220630
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2022
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sexual Dysfunction

Intervention

Behavioral:
• mindfulness yoga
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).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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').	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Primary	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.	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Primary	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.	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Secondary	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.	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Secondary	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	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Secondary	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	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Secondary	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.	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Secondary	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.	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Secondary	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.	4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention