Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer (DACG VI)

Aarhus University Hospital

Status: Enrolling

Conditions: Anal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07296237

1-10-72-19-25 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design