跳至主要内容
临床试验/NCT03935698
NCT03935698已完成不适用

Physiotherapy Treatment in Gynecological Cancer Survivors Suffering From Dyspareunia: a Mixed-Method Pilot Study

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Retention rate

研究概览

简要总结

Gynecological cancers represent more than half of female cancers. It has been clearly established that cancer survivors suffer from important health issues such as pain during sexual intercourse (dyspareunia) and sexual dysfunctions which sorely impact their quality of life. Although it affects more than 63% of cancer survivors, the available treatments remain limited and poorly studied. Cancer survivors are thus confronted with these health issues as well as relationship difficulties and psychological consequences, with limited treatment avenues. Addressing pelvic floor muscle dysfunctions and loss of vaginal elasticity, pelvic floor physiotherapy was shown to be effective in reducing or even alleviating dyspareunia and improving sexual function. Until now, no study investigated this treatment in gynecological cancer survivors with dyspareunia. Therefore, there is a need to examine pelvic floor physiotherapy to determine whether or not gynecological cancer survivors with dyspareunia could benefit from this treatment. The objectives of this single-arm mixed-method study are to evaluate the acceptability and feasibility of a physiotherapy treatment in gynecological cancer survivors suffering from dyspareunia and to explore treatment effects. This single-arm study using mixed methods will involve three data collections (pre- and post-treatment assessments). These assessments will be carried out by physiotherapists. Participants will receive physiotherapy treatment weekly in individual 60-minute sessions for 12 weeks. Thirty-one gynecological cancer survivors with vulvovaginal pain during sexual intercourse for at least 3 months will be recruited. The results of this study will bring new information regarding physiotherapy treatment for this population in preparation for a definitive randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
  • Scheduled oncological treatments completed with no signs of cancer for at least 3 months
  • Vulvovaginal pain during sexual intercourse for at least 3 months

排除标准

  • Vulvovaginal pain before cancer and not related to sexual intercourse
  • Medication recognized to affect pain
  • Refuse to stop other treatments until post-treatment assessment
  • Other conditions interfering with assessment

结局指标

主要结局

Retention rate

时间窗: Pre- to 2-week post-treatment assessment

To determine feasibility.

Adherence rates

时间窗: Pre- to 2-week post-treatment assessment

To determine acceptability.

次要结局

  • Change from baseline in sexual function(Pre- to 2-week post-treatment assessment)
  • Patient's global impression of change(2-week post-treatment assessment)
  • Change from baseline in pain(Pre- to 2-week post-treatment assessment)
  • Change from baseline in pelvic floor muscle function(Pre- to 2-week post-treatment assessment)
  • Change from baseline in quality of life(Pre- to 2-week post-treatment assessment)
  • Adverse events(Pre- to 2-week post-treatment assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mélanie Morin

Researcher and Associate Professor

Université de Sherbrooke

研究点 (2)

Loading locations...

相似试验