Late Side-effects After Cervical Cancer Treatment - Prevention and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility - participants willingness to be included
研究概览
简要总结
Late side-effects following gynecological cancer are predominantly symptoms from the pelvic region originating from the bowels, urinary tract, lymphatic system, genitals and musculoskeletal system. Pelvic floor dysfunctions such as urinary- and anal incontinence, pelvic organ prolapse, vaginal stenosis as well as compromised sexual function and dyspareunia appear to be highly prevalent. The incidence of gynecological cancer in Norway was 1700 in 2020 and the survival rate in Norway is among the highest in the world. Most women with cervical cancers are treated with curative intension and life expectancy at 5 years after diagnosis is >80%.
A negative impact of pelvic floor disorders on psychosocial well-being and quality of life are seen in survivors of gynecological cancer, and in cancer survivors this is found to be directly linked with patients regaining continence. Pelvic floor muscle training has few or no side effects, and is acknowledged as first line treatment for all types of urinary incontinence in women. Even though less studied, there is evidence to support pelvic floor muscle training as a safe intervention to reduce symptoms of anal incontinence and improve sexual function. A recent comparative cross-sectional study found that survivors of gynecological cancer with dyspareunia had higher stiffness and lower flexibility, coordination and endurance of the pelvic floor muscles compared to women with a history of total hysterectomy but no pelvic pain. These findings suggest a possible role for pelvic floor muscle training in the prevention and treatment of pelvic floor disorders after gynecological cancer. However, the overall quality of evidence for strengthening the pelvic floor muscles to reduce symptoms of pelvic floor dysfunctions after treatment of gynecological cancer is low.
This study aims to assess the feasibility of a digital pelvic floor rehabilitation programme led by an experienced pelvic floor physiotherapist. Study subjects are women treated for cervical cancer within the past 5 years, and all included participants will receive the intervention due to the feasibility design. Participants will be assessed clinically at baseline and endpoint, partly to ensure proper pelvic floor muscle contraction. The digital intervention ensures residents in rural areas equal access to specialized pelvic floor rehabilitation.
详细描述
Introduction:
The primary goal of cancer treatment is to cure the disease or considerably prolong life, and secondary to improve the patient's quality of life. However, more than 500 distinct kinds of late side effects have been associated with modern cancer therapy ranging from minor, asymptomatic changes to life-threatening injuries and death. Many cancer survivors do not regain their previous level of health and functioning. Thus, as life expectancy after cancer is increasing, more people are living with substantial and permanent bodily changes negatively affecting quality of life. Based on this, the Norwegian Women's Public Health Association (N.K.S.) has identified a knowledge gap in cancer treatment, with a main focus on prevention and treatment on late side-effects in "cancer affecting women" in the strategic research plan for 2018-2024.
Gynecological cancer includes cancer in the cervix, uterus, ovaries/fallopian tubes and vulva with an estimated global prevalence of 1.31 million new cases each year. Women diagnosed with uterine-, ovarian/fallopian tube and vulvar cancer are on average aged >60 years, while women diagnosed with cervical cancer are younger with a median age of 45 years. The incidence of gynecological cancer in Norway was 1700 in 2020b and the survival rate in Norway is among the highest in the world. Most women with cervical cancers are treated with curative intension and life expectancy at 5 years after diagnosis is >80%.
Late side-effects following gynecological cancer are predominantly symptoms from the pelvic region originating from the bowels, urinary tract, lymphatic system, genitals and musculoskeletal system. Pelvic floor dysfunctions such as urinary- and anal incontinence, pelvic organ prolapse, vaginal stenosis as well as compromised sexual function and dyspareunia appear to be highly prevalent. According to a recent systematic review including 31 studies of pelvic floor disorders in gynecological cancer survivors, prevalence of urinary incontinence was reported up to 76%, fecal incontinence up to 37% and dyspareunia up to 58%. However, study quality tended to be poor, and the need for more comparative data on pelvic floor disorders among gynecological cancer survivors and the general population is highlighted by several studies included in the review. A negative impact of pelvic floor disorders on psychosocial well-being and quality of life are seen in survivors of gynecological cancer, and in cancer survivors this is found to be directly linked with patients regaining continence.
Pelvic floor muscle training has few or no side effects, and is acknowledged as first line treatment for all types of urinary incontinence in women, and mild-moderate pelvic organ prolapse. Even though less studied, there is evidence to support pelvic floor muscle training as a safe intervention to reduce symptoms of anal incontinence and improve sexual function. The pelvic floor muscles is a three-layered muscle group covering the inside of the pelvis constituting the "floor" of the truncus. This muscle group encloses the urethra, vagina and rectum, and is involved in the continence mechanism, elimination, sexual arousal and support of the pelvic organs. There is evidence that structured pelvic floor muscle training increases muscle volume and stiffness, closes the levator hiatus and elevates the resting position of bladder and rectum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed and treated for cervical cancer (surgery, radiation- or chemo therapy) within the last five years
- •Cancer stadium I-III
- •Adequate knowledge in Norwegian.
排除标准
- •- Previous pelvic radiation therapy or pelvic surgery.
研究组 & 干预措施
Digital pelvic floor exercise group
干预措施: Pelvic floor muscle training rehabilitation (Other)
结局指标
主要结局
Feasibility - participants willingness to be included
时间窗: The time frame is pre-defined as one year recruitment period
Participants willingness to be included (measured by inclusion rate i.e. how many are included out of the total number asked)
Adherence - participants adherence to the intervention
时间窗: From enrollment until the end of the treatment at 16 weeks
Participants adherence to the intervention, measured by how many group exercises they part-take in out of the total number of 32 group exercises
Compliance to home exercises
时间窗: From enrollment until the end of the treatment at 16 weeks
Participants compliance to the intervention. Participants are encouraged to do home exercises 3 times weekly (equals 48 exercise sessions over the intervention period). This is measured through reports in their training diary.
Participants impression of change
时间窗: From enrollment until the end of the treatment at 16 weeks
Participants impression of change following the intervention, measured by the Patient Global Impression of Change. Scale from 1-7, higher score indicating better outcome.
次要结局
- Symptoms of urinary incontinence(From enrollment until the end of the treatment at 16 weeks)
- Symptoms and severity of anal incontinence(From enrollment until the end of the treatment at 16 weeks)
- Symptoms of bowel dysfunction(From enrollment until the end of the treatment at 16 weeks)
- Symptoms of sexual dysfunction(From enrollment until the end of the treatment at 16 weeks)
- Pelvic pain symptoms(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Symptoms of sexual distress(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Quality of life questionnaire (EORTC QLQ-C30)(From enrollment until the end of the treatment at 16 weeks)
- Quality of life QLQ-CX24(From enrollment until the end of the treatment at 16 weeks)
- Symptoms of secondary lower limb lymphedema(From enrollment until the end of the treatment at 16 weeks)
- Pelvic floor muscle strength (digital palpation)(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Pelvic floor muscle strength (pressure manometer)(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Pelvic floor muscle resting tone(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Pain sensitization of the vestibulum(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Pelvic floor muscle morphology(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Physical activity (frequency)(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Physical activity (intensity)(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))
- Physical activity (how long)(From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention))