Anal Cancer
Conditions
Keywords
anal cancer, Radiotherapy, Sexual dysfunction, Female sexual health, Gynecological side effects, Patient-reported outcomes
Brief summary
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.
Interventions
None listed
Sponsors
Department of Oncology, Vejle Hospital
Department of Oncology Herlev Hospital, Denmark
Aarhus University Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Previous pelvic radiotherapy for another disease * Treated with electron beam radiotherapy * Unable to speak or understand Danish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gynecological findings at examination after radiotherapy for anal cancer | Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy | 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 | Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy | 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 | Single questionnaire assessment at study visit, 6 to 36 months after completion of chemoradiotherapy | 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 | Retrospective analysis of radiotherapy plans after study inclusion | 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. |
| Patient satisfaction with guidance on gynecological and sexual side effects | Single telephone interview within 3 months after study inclusion | This outcome measures how satisfied participants are with the information and support they received about vaginal and sexual side effects after radiotherapy. Data are collected through semi-structured telephone interviews, which explore timing, clarity, and usefulness of the guidance. Interview data are analysed using thematic analysis. |
Countries
Denmark
Contacts
Primary ContactJohanne H. Steffensen, MD.
Outcome results
None listed