DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer
研究概览
简要总结
The goal of this observational study is to learn how radiotherapy for anal cancer affects the vaginal and sexual health of women after treatment. The study will also look at whether the radiation dose to the vagina is linked to the level of vaginal problems.
The main questions this study aims to answer are:
- How many women develop moderate or severe narrowing of the vagina after radiotherapy?
- Is there a link between the radiation dose and vaginal problems?
- How do vaginal changes affect sexual health and daily life?
- What care and support do women receive, and how satisfied are they with this support?
Participants are women aged 18 years or older who were treated with chemotherapy and radiotherapy for anal cancer and are 6 to 36 months after treatment.
Participants will:
Have a gynaecological examination to check the vagina for changes such as narrowing, stiffness, bleeding, or scarring Complete online questionnaires about quality of life and sexual health Answer questions about use of vaginal dilators, hormone treatment, and sexual counselling Allow researchers to analyse their radiotherapy scans to measure how much radiation the vagina received Some participants will also take part in a telephone interview about their experience with guidance and support after treatment
The study will include about 80 participants across three Danish hospitals. About 20 participants will take part in the interview part of the study.
The results from this study may help improve how doctors and nurses prevent, detect, and treat vaginal and sexual problems after radiotherapy for anal cancer. This may lead to better support and quality of life for future patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Women aged 18 years or older
- •Diagnosed with anal cancer
- •Treated with chemoradiotherapy with curative intent
- •Between 6 and 36 months since completion of radiotherapy
- •Able and willing to give written informed consent
排除标准
- •Previous pelvic radiotherapy for another disease
- •Treated with electron beam radiotherapy
- •Unable to speak or understand Danish
结局指标
主要结局
Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer
时间窗: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
This outcome measures how many participants have moderate or severe narrowing of the vagina after treatment for anal cancer. Vaginal stenosis will be assessed during a gynaecological examination using a standard clinical grading system CTCAE v. 5.
次要结局
- Gynecological findings at examination after radiotherapy for anal cancer(Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy)
- Patient-reported sexual health and quality of life after radiotherapy for anal cance(Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy)
- Use of vaginal dilators, hormone treatment, and sexual counselling after radiotherapy(Single questionnaire assessment at study visit, 6 to 36 months after completion of chemoradiotherapy)
- Radiation dose to the vagina and its relation to vaginal stenosis(Retrospective analysis of radiotherapy plans after study inclusion)
- Patient satisfaction with guidance on gynecological and sexual side effects(Single telephone interview within 3 months after study inclusion)
研究者
Johanne Hollands Steffensen
MD.
Aarhus University Hospital