Clinical trial NCT06411041: Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga
Official title: Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga on Relieving Genitourinary Symptoms, and Improving Sexual Function and Quality of Life in Asian Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Genitourinary Symptoms
Sexual Function
Quality of Life
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will receive regular care and a 12-week program of pelvic floor muscle training (PFMT) and yoga. The control group will receive regular care.
Primary purpose: TREATMENT

Brief summary: This study aims to examine the effects of Pelvic Floor Muscle Training (PFMT) combined with yoga on relieving genitourinary symptoms, symptom-related quality of life, and improving sexual function in women with breast cancer. This study is a parallel randomized study with two groups. Women will be assigned to the experimental or control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. The control group will receive regular care. We collect relevant data from both groups at baseline and 4, 8, 12, and 24 weeks after baseline during the study period.

Detailed description: This study will be conducted with the approval obtained from the Institutional Review Board (IRB) of MacKay Memorial Hospital. This parallel-two-group randomized experimental study including an experimental group and a control group examines the effects of pelvic floor muscle training (PFMT) combined with yoga on genitourinary symptoms, symptom-related quality of life, and sexual function. A sample of women with breast cancer experiencing ≥1 genitourinary symptom(s) will be recruited and assigned to an experimental group or a control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. We will provide the experimental group with 12 days of online group practice sections of PFMT and yoga (weekly 60-minute practice incudes yoga 40 minutes, PFMT 15 minutes, and reflection 5 minutes). We expect them to perform 36 days of home-based practice of PFMT and yoga with 3 days/week of yoga for 40 minutes and PFMT for 15 minutes. The control group will receive regular care and relevant educational materials after data collection. Information will be collected at five time points: baseline and 4, 8, 12, and 24 weeks after baseline. Generalized estimating equation procedures will be used to examine the effects of the intervention. We hypothesized that the experimental group will display more significant improvements in genitourinary symptoms, symptom-related influences, and sexual function than those shown in the control group.

Eligibility criteria: Inclusion Criteria:

* Women aged 20-60 years
* Women with a confirmed diagnosis of breast cancer (Stages I-III) for ≥3 months
* Women who experience ≥1 genitourinary symptom(s)

Exclusion Criteria:

* Women with other types of cancer diagnoses (e.g., endometrial cancer and ovarian cancer)
* Women with inadequately managed chronic conditions (e.g., an individual with diabetes having HbA1c level \>7%)

Primary outcomes:
measure: Vulvovaginal Symptoms
timeFrame: Baseline
measure: Vulvovaginal Symptoms
timeFrame: 4 weeks after baseline
measure: Vulvovaginal Symptoms
timeFrame: 8 weeks after baseline
measure: Vulvovaginal Symptoms
timeFrame: 12 weeks after baseline
measure: Vulvovaginal Symptoms
timeFrame: 24 weeks after baseline
Secondary outcomes:
measure: Urinary symptoms
timeFrame: Baseline
measure: Urinary symptoms
timeFrame: 4 weeks after baseline
measure: Urinary symptoms
timeFrame: 8 weeks after baseline
measure: Urinary symptoms
timeFrame: 12 weeks after baseline
measure: Urinary symptoms
timeFrame: 24 weeks after baseline
Other outcomes:
measure: Sexual function
timeFrame: Baseline
measure: Sexual function
timeFrame: 4 weeks after baseline
measure: Sexual function
timeFrame: 8 weeks after baseline
measure: Sexual function
timeFrame: 12 weeks after baseline
measure: Sexual function
timeFrame: 24 weeks after baseline
measure: Quality of life and distress associated with pelvic floor symptoms
timeFrame: Baseline
measure: Quality of life and distress associated with pelvic floor symptoms
timeFrame: 4 weeks after baseline
measure: Quality of life and distress associated with pelvic floor symptoms
timeFrame: 8 weeks after baseline
measure: Quality of life and distress associated with pelvic floor symptoms
timeFrame: 12 weeks after baseline
measure: Quality of life and distress associated with pelvic floor symptoms
timeFrame: 24 weeks after baseline
Locations:
city: Taipei City
country: Taiwan
facility: MacKay Memorial Hospital
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Yuan-Mei Liao, PhD
role: PRINCIPAL_INVESTIGATOR
References: