Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
NCT ID: NCT07296237
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2025-11-13
2026-09-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 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
* Treated with electron beam radiotherapy
* Unable to speak or understand Danish
18 Years
FEMALE
No
Sponsors
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Department of Oncology, Vejle Hospital
UNKNOWN
Department of Oncology Herlev Hospital, Denmark
UNKNOWN
Aarhus University Hospital
OTHER
Responsible Party
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Johanne Hollands Steffensen
MD.
Locations
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Department of Oncology Aarhus University Hospital (AUH)
Aarhus, , Denmark
Department of Oncology, Herlev and Gentofte Hospital
Herlev, , Denmark
Department of Oncology Vejle Hospital, University Hospital of Southern Denmark
Vejle, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Johanne H. Steffensen, MD, PhD
Role: primary
Eva Serup-Hansen, MD. PhD
Role: primary
Lars U. Fokdal, MD, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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1-10-72-19-25
Identifier Type: OTHER
Identifier Source: secondary_id
1-10-72-19-25
Identifier Type: -
Identifier Source: org_study_id