Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Vaginal dryness (NRS)
研究概览
简要总结
Breast cancer survivors (BCS) often face unique challenges during and after treatment, including the onset of menopause-related symptoms. Genitourinary Syndrome of Menopause (GSM) is a common concern in BCS undergoing endocrine therapy (ET). It is a chronic condition caused by estrogen deficiency, leading to vaginal and urinary symptoms such as dryness, irritation, pain during intercourse, recurrent infections, and urinary urgency.
The prevalence of GSM in BCS varies widely depending on factors such as the type of ET, individual patient characteristics, and the duration of treatment. As such, the prevalence of GSM in BCS can range from 13% to 95.2%. A recent systematic review performed by part of the investigators of this study concludes that GSM is a significant problem for breast cancer patients. However, most studies lack a control group, limiting the results' validity. Therefore, this study aims to determine the extent of the GSM burden in BCS using a prospective, controlled cohort study. This study will compare breast cancer patients receiving endocrine therapy (ET) with those undergoing chemotherapy (CT), as CT may also induce GSM-like symptoms. In addition, a comparison will be made with healthy controls.
For this study, two groups of participants are included: women with breast cancer and a healthy control group without breast cancer. Within the breast cancer group, a distinction is made between women receiving chemotherapy only and women undergoing hormone therapy only. All participants complete questionnaires. The control group completes these questionnaires once, whereas women with breast cancer are asked to complete the same questionnaires at multiple time points during their treatment and follow-up. This longitudinal approach allows us to assess how potential symptoms evolve over the course of treatment. By comparing responses between both groups, a clearer understanding of which symptoms occur more frequently in women with breast cancer as a consequence of their treatment can be obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women diagnosed with breast cancer stage 0, I, II, and III
- •Prior to CT/ET, receiving only one of both (no combination)
- •Age 18 years or above
- •Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
- •Dutch-speaking (be able to understand the informed consent and study-related questionnaires)
- •Signed informed consent
排除标准
- •Concomitant CT and ET treatment
- •Structural restorative therapies, such as photobiomodulation therapy (PBM) and fractional CO₂ laser treatment, are not permitted during the study period. During the study period, only symptomatic treatment of GSM (e.g., vaginal lubricants or moisturizers) will be allowed
研究组 & 干预措施
Healthy controls
The control group includes healthy biological women who are matched with the included breast cancer patients. Factors for matching include: Age; BMI; Menopausal status (for breast cancer patients: prior to treatment)
干预措施: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R) (Other)
Breast cancer patients receiving endocrine therapy
干预措施: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R) (Other)
Breast cancer patients receiving chemotherapy
干预措施: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R) (Other)
结局指标
主要结局
Vaginal dryness (NRS)
时间窗: From enrollment up till 12 months later.
The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal dryness. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
Vaginal pruritus (NRS)
时间窗: From enrollment up till 12 months later.
Description: The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal pruritus. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
Vaginal discharge (NRS)
时间窗: From enrollment up till 12 months later.
The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal discharge. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
Vaginal hemorrhage (NRS)
时间窗: From enrollment up till 12 months later.
The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal hemorrhage. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
Vaginal burning sensation (NRS)
时间窗: From enrollment up till 12 months later.
The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal burning sensation. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
次要结局
- Sexual Functioning Score(From enrollment up till 12 months.)
- Sexual Distress Score(From enrollment up till 12 months.)
- Quality of Life Score(From enrollment up till 12 months later.)
- Quality of Life Score - Breast Cancer Specific(From enrollment up till 12 months later.)
- Mental Health(From enrollment up till 12 months later.)