Actively Recruiting
DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
Led by Aarhus University Hospital · Updated on 2025-12-22
80
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
D
Department of Oncology, Vejle Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how radiotherapy for anal cancer affects vaginal and sexual health in women after treatment. It focuses on how often moderate to severe vaginal narrowing occurs, whether radiation dose to the vagina is linked to vaginal problems, and how these changes impact sexual health and daily life. The study also evaluates the care and support women receive after treatment and their satisfaction with it. Participants are women aged 18 years or older who received chemotherapy and radiotherapy aimed at curing anal cancer and are between 6 and 36 months post-treatment. Researchers will review radiotherapy scans to measure vaginal radiation exposure. Some participants will join a telephone interview to share their experiences with post-treatment guidance and support. During the study visit, participants will have a gynecological exam to check for vaginal changes like narrowing, stiffness, bleeding, or scarring. They will complete online questionnaires about sexual health and quality of life and answer questions about vaginal dilator use, hormone treatment, and sexual counseling. The main outcome measured is the prevalence of moderate to severe vaginal narrowing after treatment. The study plans to include about 80 women across several hospitals, with around 20 participating in interviews to better understand patient support needs.
CONDITIONS
Brief Title
Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Previous pelvic radiotherapy for another disease
- Treated with electron beam radiotherapy
- Unable to speak or understand Danish
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - One-time assessment between 6 and 36 months after completing radiotherapy
Participants undergo a single assessment to evaluate gynecological and sexual health after radiotherapy for anal cancer.
1 visit (in-person)
Duration - Within 3 months after study inclusion
Participants complete a telephone interview to assess satisfaction with guidance on gynecological and sexual side effects.
1 telephone interview
Trial Site Locations
Total: 3 locations
1
Department of Oncology Aarhus University Hospital (AUH)
Aarhus, Denmark, 8200
Actively Recruiting
2
Department of Oncology, Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
3
Department of Oncology Vejle Hospital, University Hospital of Southern Denmark
Vejle, Denmark, 7100
Actively Recruiting
Research Team
J
Johanne H. Steffensen, MD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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