Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anal Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
Overview
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.
Primary outcome measures
- Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer [Time frame: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy]
Secondary outcome measures (5)
- Gynecological findings at examination after radiotherapy for anal cancer [Time frame: 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 [Time frame: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy]
- Use of vaginal dilators, hormone treatment, and sexual counselling after radiotherapy [Time frame: 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 [Time frame: Retrospective analysis of radiotherapy plans after study inclusion]
- Patient satisfaction with guidance on gynecological and sexual side effects [Time frame: Single telephone interview within 3 months after study inclusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 3 centers
- Department of Oncology Aarhus University Hospital (AUH) — Aarhus
- Department of Oncology, Herlev and Gentofte Hospital — Herlev
- Department of Oncology Vejle Hospital, University Hospital of Southern Denmark — Vejle
Identifiers
NCT: NCT07296237 · 1-10-72-19-25 · 1-10-72-19-25