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.
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
Previous pelvic radiotherapy for another disease
Treated with electron beam radiotherapy
Unable to speak or understand Danish
The study population includes adult women who have been treated with chemoradiotherapy for anal cancer in Denmark. Participants are recruited during routine follow-up visits at three oncology departments. All participants are between 6 and 36 months after treatment and are in cancer follow-up care
Cohort
Cross-sectional
Not listed
Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer
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.
Gynecological findings at examination after radiotherapy for anal cancer
This outcome measures physical changes in the vagina assessed during a standardised gynaecological examination. Findings include vaginal stiffness, scarring, fragile tissue with bleeding, small visible blood vessels, ulcers, and adhesions. All findings are recorded using a structured electronic clinical examination form based on established vaginal morbidity assessment methods.
Patient-reported sexual health and quality of life after radiotherapy for anal cance
Participants complete validated questionnaires covering sexual health and quality of life: * EORTC QLQ-C30 and EORTC QLQ-ANL27 for general and anal cancer-specific quality of life * EORTC QLQ-SH22 for sexual health, including vaginal dryness, pain, and sexual satisfaction * Female Sexual Function Index (FSFI) for sexual desire, arousal, lubrication, orgasm, satisfaction, and pain All questionnaires use fixed response scales and are scored according to official scoring manuals.
Use of vaginal dilators, hormone treatment, and sexual counselling after radiotherapy
This outcome measures how often participants use vaginal dilators, whether they use local or systemic hormone treatment, and whether they have received specialised sexual counselling after radiotherapy. Data are collected using a structured pattern-of-care questionnaire completed by participants.
Radiation dose to the vagina and its relation to vaginal stenosis
This outcome measures the radiation dose received by the vagina during treatment and examines its relation to moderate or severe vaginal stenosis. The vagina is outlined retrospectively on radiotherapy planning scans, and dose-volume data are extracted from treatment plans. These dose data are analysed in relation to clinical findings of vaginal stenosis.
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Aarhus University Hospital
Lead sponsor
Department of Oncology, Vejle Hospital
Collaborator
Department of Oncology Herlev Hospital, Denmark
Collaborator
