SPARC Study: A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy: a Randomized Multicentre Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 8
- 主要终点
- Change from 1 month in Sexual functioning at 12 months post RT/RTBT
研究概览
简要总结
The aim of this randomized controlled trial is to demonstrate that a nurse-led sexual rehabilitation intervention significantly improves sexual recovery and functioning among gynaecological cancer (GC) patients treated with radiotherapy (RT), compared with usual care (i.e., oral information by a nurse or doctor and written information).
Women with GC (n=220) who receive RT in one of the participating Dutch GC centres (n=9) will be randomized to either the sexual rehabilitation intervention (n= 110) or usual care (n= 110), stratified for combined RTBT vs. RT alone, and for having a partner (yes/no). Women are eligible for participation if they: have been diagnosed with either cervical, endometrial, or vaginal cancer; are treated with radiotherapy; are 18 years or older; and wish to retain their sexual activity on the short or long term.
The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT. Women who received RTBT will receive an additional appointment with the nurse (2 months after RTBT) to promote regular use of vaginal dilators in order to prevent stenosis. Participants are requested to complete questionnaires at baseline and at 1, 3, 6, and 12 months post-RT.
The primary endpoint is sexual functioning at 12 months. Secondary endpoints include vaginal symptoms and body concerns, fear of coital and non-coital sexual activity, sexual distress, treatment-related distress, generic health-related quality of life, psychological distress, and relationship dissatisfaction.
Hypothesis: The investigators expect women who receive the nurse-led sexual rehabilitation programme to report a greater improvement in sexual functioning from immediate post-radiotherapy to 1 year post-radiotherapy than women in the control group.
详细描述
The primary objective of this randomized controlled trial is to evaluate if the nurse-led sexual rehabilitation intervention improves sexual recovery and functioning in patients with gynaecological cancers (GC) who are treated with either external pelvic radiotherapy only (i.e., RT) or external pelvic radiotherapy combined with brachytherapy (i.e., RTBT) compared with usual care (Q1).
The secondary objective is to evaluate if the nurse-led sexual rehabilitation program decreases vaginal symptoms and body image concerns, fear of (non-)coital sexual activity, treatment-related distress, psychological and sexual distress, and vaginal physical symptoms (assessed during physical examination by the radiation oncologist), and improves/increases generic-related health related quality of life related to gynaecological cancer, relationship satisfaction, and frequency of dilator use, (Q2); to evaluate the cost-effectiveness of the intervention (Q3); and to evaluate whether an improvement in sexual functioning is moderated by treatment characteristics and pre-treatment patient characteristics, such as age or sexual functioning, and mediated by reduction of vaginal symptoms (and by regular use of dilators in women treated with RTBT) (Q4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •being diagnosed with on of the following gynaecological cancers: cervical cancer, endometrial cancer or vaginal cancer
- •18 years or older
- •receiving radiotherapy for gynaecological cancer (RT/RTBT)
- •wish to retain sexual activity in the short- or long-term.
排除标准
- •being unavailable for follow-up
- •having insufficient knowlegde of the Dutch language
- •having a psychiatric disorder (e.g. major affective disorder, psychotic disorder, substance abuse disorder (i.e., alcohol, drugs), or posttraumatic stress disorder resulting from abuse in the pelvic floor and/or genitals (e.g., sexual abuse)).
结局指标
主要结局
Change from 1 month in Sexual functioning at 12 months post RT/RTBT
时间窗: 12 months
The primary outcome measure is sexual functioning and will be assessed with the Dutch version of the 19-item Female Sexual Function Index (FSFI) questionnaire. The FSFI consists of 6 subscales measuring sexual desire (scoring range: 0.6 - 6.0), arousal (scoring range: 0 - 6.0), lubrication (scoring range: 0 - 6.0), orgasm (scoring range: 0 - 6.0), satisfaction (scoring range: 0.8 - 6.0), and pain (scoring range: 0 - 6.0). The scores of the questions are added per subscale, after which they are multiplied by a factor depending on the subscale ( sexual desire: 0.6; arousal: 0.3; lubrication: 0.3; orgasm: 0.4; satisfaction: 0.4; pain: 0.4) to give them a subscale score. By adding all 6 subscales together, the total score of the FSFI is obtained. The total score reflects overall sexual functioning (scoring range: 2.0 - 36.0). Higher scores indicate better sexual functioning. (measured at 1, 3, 6, 12 months post RT/RTBT and retrospectively (sexual functioning before diagnosis) at baseline
次要结局
- Change from 1 month Generic health-related quality of life related to gynaecological cancer at 12 months post RT/RTBT(12 months)
- change from 1 month in Psychological distress at 12 months post RT/RTBT(12 months)
- Changes from 1 month in Vaginal symptoms and body image concerns at 12 months post RT/RTBT(12 months)
- Change from 1 month in Fear of coital and non-coital sexual activity at 12 months post RT/RTBT(12 months)
- Change from 1 month in Level of sexual distress at 12 months post RT/RTBT(12 months)
- Change from 1 month in Treatment related distress at 12 months post RT/RTBT(12 months)
- Change from 1 month in Relationship dissatisfaction at 12 months post RT/RTBT(12 months)
- Change from baseline in Vaginal symptoms at 12 months post RT/RTBT(12 months)
- Change from 1 month in Frequency of dilator use at 12 months post RTBT(12 months)
- Cost-effectiveness(12 months)
研究者
MMterKuile
PhD, clinical psychologist, associate professor
Leiden University Medical Center